Black and white microscope in a lab

Coronavirus:

COVID-19 News As It Relates to Autoimmune Disease

*Updated September 24, 2021

An ongoing timeline summarizing key COVID-19 scientific developments, especially as it pertains to autoimmune disease

Questions about COVID-19 vaccines and autoimmune disease? Check out our vaccine FAQ.

CDC Statement on ACIP Booster Recommendations

September 24, 2021

This morning, the CDC released a statement regarding who should get a Pfizer COVID-19 vaccine booster. In an unexpected move, the CDC overruled the Advisory Committee on Immunization Practices’ (ACIP) recommendations from yesterday, when they voted 6-9 against recommending a booster for those at high risk of occupational exposure (such as healthcare workers).

These are the updated CDC recommendations:

  • people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
  • people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

New study investigates COVID-19 vaccine in rheumatoid arthritis, scleroderma, myositis, and Sjogren’s syndrome patients

September 23, 2021

The University of Pittsburgh Medical Center is recruiting participants for a new study investigating the immune response to the COVID-19 vaccine in those living with autoimmune disease, to include rheumatoid arthritis, scleroderma, myositis, and Sjogren’s syndrome.

Autoimmune disease patients were not included in original COVID-19 vaccine clinical trials, and there is “little information regarding the COVID-19 vaccine’s effectiveness and overall safety for patients with autoimmune diseases.” The study will measure antibody levels against SARS-CoV-2, and track whether vaccination leads to disease flares, changes in symptoms, or adverse effects.

To learn more about the study, as well as information on participating, click here.

Results of Friday’s FDA advisory committee meeting

September 20, 2021

Last Friday, the FDA’s key advisory committee convened for an 8-hour meeting to discuss and vote on boosters for those 16+ years of age. 84% of committee members voted “no” on boosters for the general population, citing safety concerns and a lack of data on the reduction of transmission after a third dose. In an unexpected turn of events, the FDA advisory committee created and voted on a second question, as to whether the known and potential benefits outweigh the known and potential risks of the Pfizer Covid booster – at least 6 months after the primary series – for use in those 65+ and those at high risk of severe COVID-19. Panelists voted “yes” unanimously. 

Since “high risk” can be broadly interpreted, many Americans who wish to be given a booster may be eligible. Additional doses for immunocompromised persons, including those with autoimmune disease who may not have developed sufficient antibodies after their primary vaccination series, are eligible for a COVID-19 booster dose. 

The FDA typically follows the committee’s recommendations, but it is not mandatory that they do so. The FDA will most likely issue a decision this week, possibly before the CDC’s ACIP meeting on Wednesday. The CDC will develop vaccine policy based on the recommendations of the CDC advisory committee.

Autoantibodies can predict development of severe COVID-19 by up to 92.8%

September 16, 2021

A study published last week in Life Science Alliance analyzed blood samples from 115 patients hospitalized with SARS-CoV-2 and 42 uninfected controls and discovered the presence of autoantibodies in 36% of COVID-19 hospital patients. A strong association was made between the presence of these self-attacking immune system defense molecules and the more severe COVID-19 cases. Researchers focused on anti-DNA and anti-PS antibodies, determining that these antibodies could predict the later development of severe disease by 85.7% and 92.8%, respectively.

The authors went on to conclude that “anti-DNA and anti-PS autoantibodies may play an important role in the pathogenesis of COVID-19 and could be developed as predictive biomarkers for disease severity and specific clinical manifestations.” Their observations suggest that the most severe forms of disease observed in COVID-19 patients may be a result of the host response to infection, rather than a direct consequence of viral cytopathic effect (structural changes in host cells that are caused by viral invasion), which is similar to what occurs in some autoimmune diseases.

Risk of relapse is low for MS patients after COVID-19 vaccination, study finds

September 15, 2021

Research published in the Journal of Neurology, Neurosurgery, and Psychiatry has indicated that multiple sclerosis (MS) patients did not see a rise in symptoms following COVID-19 vaccination with the Pfizer vaccine. Cohort characteristics included 93.5% of patients having relapsing-remitting MS, 4.6% having secondary progressive disease, and 1.9% having primary progressive disease.

The study included 324 MS patients, of which six experienced relapses in the two months prior to vaccination, and seven encountered clinical relapses within two months after being vaccinated. “The incidence of relapses in the 2 months before and after vaccination was not statistically different.” The mean time between receiving the first vaccine and experiencing a relapse was 44 days, with no effect from factors such as age, gender, and duration of disease.

This is the first study to follow MS patients for at least two months after receiving the first dose of the Pfizer vaccine. Of the 324 participants included in the study, 322 received both doses.

What is a sarbecovirus and how can it help protect us against variants?

September 14, 2021

SARS-CoV-2 is a subspecies of virus within the subgenus of sarbecovirus, which are all respiratory viruses. The easiest way to picture the lineage is by thinking of a family tree with a grandparent, parent, and kids.

Chart depicting relation between the coronavirus, sarbecovirus, and SARS-CoV-2

Here we can see that the “grandparent” is the overarching genus of beta coronaviruses (one of four types of coronaviruses, which include alpha-, gamma-, and delta-). Following the family tree, we can think of the sarbecoviruses as being the “parent” and under that we have the group of “kids” which are the types of coronaviruses we have been battling in recent years (SARS in early 2000, MERS in the mid-2010s, and now COVID-19). They may all be in the same family tree and share a good amount of their genetic material, but as we have learned through the evolution of SARS-CoV-2 variants, they are not all identical. We know this because having COVID-19 does not mean you are protected against SARS or MERS, just as having a SARS or MERS infection does not protect you against COVID-19.

In a recent Nature article, researchers gave a COVID vaccine to a group of individuals who had previously experienced a MERS and SARS infection. They found that the subjects were not only able to develop antibodies against those viruses, but also another 8-10 of the virus’ variants. This led the team to explore the idea of developing a vaccine at the “parent” level as opposed to creating multiple vaccines against all the “kids” and their variants. The authors concluded their study by stating “we anticipate [this] data will guide future efforts to develop vaccines that overcome the emergence of SARS-CoV-2 variants and that are effective against all sarbecoviruses”. This means that if we focus on developing antibodies and creating vaccines one level up, they may provide protection against all the subtypes of coronaviruses that we are seeing now and may see in the future.

Hot off the press: “Considerations in boosting COVID-19 vaccine immune responses”

September 13, 2021

This morning, The Lancet published a viewpoint article regarding COVID-19 boosters; co-authors include Dr. Krause and Dr. Gruber from the Office of Vaccines Research and Review, Food and Drug Administration (FDA).

The authors begin by addressing boosters for immunocompromised persons, stating it is still unknown whether this population would receive worthwhile benefit from an additional dose of the same vaccine, or if implementing a mix-and-match method may complement the primary immune response more effectively.

Randomized trials and observational studies have not yet shown a need for boosting the general population. “A consistent finding is that vaccine efficacy is substantially greater against severe disease than against any infection… although the efficacy of most vaccines against symptomatic disease is somewhat less for the delta variant than for the alpha variant, there is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant.” Even if antibodies appear to decrease, their reduction does not necessarily predict reductions in vaccine efficacy against mild and severe disease. Protection against severe disease utilizes antibody responses as well as memory responses and cell-mediated immunity.

Developing variant-based boosters in the same way as the influenza vaccine will increase the likelihood of the vaccine remaining effective even if there is further strain mutation. As of now, the current vaccines elicit a humoral response against circulating variants.

Granulocytes may weaken the COVID-19 immune response

September 10, 2021

Low-density granulocytes (LDG) are a type of white blood cell known to circulate at increased levels in certain autoimmune diseases (such as rheumatoid arthritis) but are still poorly understood in relation to viral infections. The rise of SARS-CoV-2 highlighted the need to investigate these cells and their mechanisms, as they are known to be one of the first cellular responders to infection.

A study recently published in PLOS Pathogens sought to determine the role that LDGs may play in the disease progression of COVID-19. The study included 55 COVID-19 infected patients (34 hospitalized and 21 outpatients), along with 14 healthy age- and sex-matched controls. After measuring LDG levels, the researchers detected a significant increase in LDGs in the blood of COVID-19 patients compared to healthy control subjects and an even more prominent increase in severe COVID-19 cases.

Further testing demonstrated the immunosuppressive capacities of these cells. LDGs are typically associated with the early innate immune response, though researchers found that their involvement in the fight against COVID-19 included inhibition of the proliferation and division of T lymphocytes. This impairment of T lymphocytes subsequently weakens the adaptive immune response against the virus and research has shown that low levels of T lymphocytes are a major indicator of developing a severe COVID-19 case versus a milder infection.

COVID-19 Vaccination Responses in IMID Patients

September 9, 2021

Today, the Research Institute of the McGill University Health Center announced a new study evaluating the impact of COVID-19 vaccines in participants living with immune-mediated inflammatory diseases (IMID). Common IMIDs include lupus, rheumatoid arthritis, Crohn’s disease, and Type 1 Diabetes. The study will include 2,500 patients with IMIDs, testing antibody levels up to 12 months after a full dose of the COVID-19 vaccine.

The efficacy and safety of COVID-19 vaccines in those with IMIDs has yet to be thoroughly studied, but merits specific investigation as this population often requires immunosuppressive drugs as part of treating their disease. These drugs have been known to inhibit a sufficient antibody response to vaccination.

One study conducted in Germany analyzed vaccine responses in untreated, conventionally treated, and anticytokine-treated patients with IMIDs. The most common autoimmune diseases included in the study were spondyloarthritis, rheumatoid arthritis, inflammatory bowel disease, and psoriasis. 42.9% of patients received biologic or targeted synthetic disease-modifying anti rheumatic drugs, 23% were treated with conventional synthetic DMARDs, and 26.8% were not on any treatment.

181 of 182 control participants created anti-SARS-CoV-2 IgG antibodies. Of 84 patients with IMIDs, 76 developed neutralizing antibodies; 5 failed to respond to vaccination altogether. Of the eight who failed to develop neutralizing activity, three were taking Janus kinase inhibitors, two methotrexate, one was being treated with an interleukin-17 inhibitor, and two IMID patients were untreated. “Roughly 1 out of 10 patients with IMID fails to develop neutralizing antibodies after SARS-CoV-2 vaccination, while it is only 1 out of 100 in the controls.”

These results show that overall responses were delayed and reduced in IMID patients regardless of treatment method compared to controls. This may be due to the fact that “patients affected by immune-mediated inflammatory diseases (IMIDs) show aberrant immune responses, increased risk to infections and are exposed by drugs that interfere with immune pathways.”

Vaccination reduces risk of Long Covid by 49% 

September 8, 2021

According to a study published in The Lancet Infectious Diseases, those who are fully vaccinated against COVID-19 are 49% less likely to develop Long Covid in the unlikely event they contract COVID-19.

Researchers at King’s College London analyzed self-reported data on the UK ZOE Covid app from approximately 1.2 million participants who received a first dose, and 970,000 participants who received a second dose of the COVID-19 vaccine. Of these cohorts, 6,030 and 2,370 tested positive for COVID-19 at least 14 and 7 days after vaccination, respectively. Users reported a COVID-19 infection an average of 73 days after their first vaccination, and an average of 51 days after their second-vaccination. The most commonly reported co-morbidities were asthma and lung disease.

While almost halving the risk of Long Covid, researchers also found that there were 73% less hospitalizations and 31% less acute symptoms by those who were fully vaccinated versus those who were unvaccinated. Symptoms were milder and less frequently reported by vaccinated individuals, and most commonly included loss of smell, fatigue, headaches, cough and fever.

UK data indicates that mortality rates across all ages parallel that of the first wave (March-April 2020) in those who are hospitalized. “Data from the International Severe Acute Respiratory and Emerging Infection Consortium have shown a mortality of 27% (400 of 1482 died) in individuals hospitalized with COVID-19 in the UK more than 21 days after vaccination.” This suggests that while COVID-19 vaccination reduces the risk of severe COVID symptoms, mortality rates in COVID-19 hospital cases remain high, at least in the UK. 

Can GBS return following COVID vaccination?

September 7, 2021

research letter, published in JAMA Network last week, studied the rate of recurrent Guillain-Barré Syndrome (GBS) following vaccination with the mRNA Pfizer-BioNTech COVID-19 vaccine and found the risk to be extremely low. This retrospective cohort study utilized medical data from the second largest health maintenance organization in Israel,* including 579 previously diagnosed GBS patients who had received at least one vaccine dose, 539 who had received two doses, and 38 who had COVID-19 and needed only one dose according to the Israeli Ministry of Health guidelines. Of these 579 patients, 48 were seen in a hospital following vaccination, though only one needed “short medical care for relapse of previous syndrome, which represents a minimal risk” according to the researchers.

* The investigators point out that the study only included hospital visits, and that details on the reason for hospitalization remained vague. Additionally, the inclusion of hospital visits alone may “underestimate other symptoms that presented only in the community. Nevertheless, any significant serious neurologic concern would probably have been evaluated in a hospital setting.”

Experiences of COVID-19 Infection and Vaccination in those with Sjogren’s

September 3, 2021

This week, Rheumatology International published a study on the impact of COVID-19 infection and vaccination in patients with Sjogren’s syndrome

The study included 137 participants who completed an online questionnaire-based survey. 31 patients responded that they previously experienced a COVID-19 infection, one of which had been completely asymptomatic. 17 patients said their symptoms lasted for at least two weeks, with the most frequent long-lasting symptoms being fatigue (40%) and weakness (36%). While three participants were hospitalized, none required admission into the ICU. 

Symptoms specific to Sjogren’s patients included more severe eye, oral, and nasal dryness (32%, 40%, and 32%, respectively). 

Additionally, 53 participants received at least one dose of the COVID-19 vaccine, and cited pain at the injection site, weakness, and myalgia as the most prevalent side effects. 10% of the study’s participants reported experiencing joint pain and fever, as well as aggravated dryness-related symptoms.

The most common reason for not getting vaccinated was feeling unsure of how the vaccine would impact their Sjogren’s diagnosis. 

~89% of those with chronic inflammatory conditions produce antibodies following vaccination, despite immunosuppressant usage

September 2, 2021

The Washington University School of Medicine is conducting a study called COVaRiPAD (COVID-19 Vaccine Responses in Patients with Autoimmune Disease). The team just published research looking at the effect of immunosuppression on the efficacy of mRNA COVID-19 vaccines. They found that 88.7% of patients with chronic inflammatory conditions* (CID), including rheumatoid arthritis (28.5%), Crohn’s disease (16.5%), spondyloarthritis (15%), ulcerative colitis (13.5%), systemic lupus erythematosus (11.3%), multiple sclerosis (6.8%), and sjögrens syndrome (6%), produced detectable antibodies in response to the vaccine.

Researchers found that immune responses varied depending on the medication being taken, which included glucocorticoids, antimetabolites, tumor necrosis factor inhibitors (TNFis), B-cell depleting therapy (BCDT), and Janus kinase inhibitors (JAKis). All CID participants continued use of their immunosuppressive medications during the study per their treating physician, except for 3 who held methotrexate (antimetabolite) within 1 week of immunization. Those taking BCDT (60%) and glucocorticoids (65%) had absent or numerically lower antibody levels after both vaccinations, while the other immunosuppressives did not generate much lower antibody levels when compared to those not taking the drugs.

It should be noted that the antibody levels in CID participants were one-third of the levels seen in the healthy controls. The researchers highlighted the difficulty of determining whether the levels achieved by those on immune-suppressing drugs are high enough to protect them from severe COVID-19 given that a minimum level of antibodies required for protection against COVID-19 has yet to be established. Nonetheless, evidence supporting that vaccination does elicit a response in those with compromised immune systems is still encouraging for a population that has a high risk of serious illness.

 * Those with acquired or inherited immunocompromised conditions and those using systemic immunosuppression were excluded.

NIH launches clinical trial studying COVID‐19 booster response in Autoimmune Disease Non‐Responders

September 1, 2021

Earlier this week, the NIH announced that they are launching a new clinical trial to determine the antibody response of a booster dose in autoimmune disease patients who did not respond to an initial full dose of the COVID-19 vaccine. 

The NIH estimates that 8% of Americans live with an autoimmune disease and this population has experienced higher rates of severe disease from COVID-19 than the general population. “It is unclear whether this is attributable to the autoimmune disease, the immunosuppressive medications taken to treat it, or both” (1). 

The trial will include 600 participants, 18+ years of age, living with one of five autoimmune diseases: rheumatoid arthritis, pemphigus, systemic lupus erythematosus, systemic sclerosis, or multiple sclerosis. Participants must be taking one of three immunosuppressive therapies, including mycophenolate mofetil (MMF) or mycophenolic acid (MPA), methotrexate (MTX), or B cell-depleting drugs. These immunosuppressive therapies have been associated with low antibody production after the COVID-19 vaccine. 

Participants will receive an extra dose of the same COVID-19 vaccine as their original dose (Moderna, Pfizer, or Johnson & Johnson). Participants taking MPA or MTX therapies will be assigned to continue or pause their medication before and after receiving the booster dose at random. 

Preliminary results are expected in November of this year. 

The ACIP votes in favor of the Pfizer vaccine

August 31, 2021

Yesterday, the CDC’s Advisory Committee on Immunization Practices (ACIP) convened to discuss the FDA approval of Pfizer’s COVID-19 vaccine, booster shots, and updates around vaccine safety.

Committee members voted unanimously in favor of the vaccine for those 16+ years of age. Pfizer’s COVID-19 vaccine was approved by the FDA on August 23, 2021; the ACIP’s recommendation forms the basis of the CDC’s public health guidance around use of the vaccine.

A representative from Pfizer offered an overview regarding safety updates of the vaccine, as well as a study currently in the recruitment phase which will measure the efficacy of the booster dose. Results can be expected in 2022. A potential recommendation around boosters is expected to be made by September 20th.

The ACIP will be convening in September to discuss the efficacy of booster shots based on available data, as well as distribution amongst at-risk populations.

Study links risk of myocarditis with Pfizer vaccination but finds even higher risk of myocarditis following COVID-19 infection

August 26, 2021

A real-world case-control study from Israel, published yesterday, studied cohorts of individuals vaccinated with the Pfizer COVID-19 mRNA vaccine and unvaccinated individuals who became infected with SARS-CoV-2 for adverse effects. The vaccination cohorts included a mean of 884,828 vaccinated persons, with a median age of 38 years, and the SARS-CoV-2 infection cohort had a total of 173,106 persons with a median age of 34 years.

They found that the vaccinated cohort was associated with an increased risk of myocarditis (2.7 events per 100,000 persons) as well as lymphadenopathy (78.4 events per 100,000 persons), appendicitis (5.0 events per 100,000 persons), and herpes zoster infection (15.8 events per 100,000 persons). Researchers noted that vaccination was “substantially protective against adverse events such as anemia, acute kidney injury, intracranial hemorrhage, and lymphopenia.”

However, it should be noted that in a separate cohort*, an even higher risk of myocarditis was found to be associated with SARS-CoV-2 infection (11.0 events per 100,000 persons), in addition to other cardiovascular complications including acute kidney injury (125.4 events per 100,000 persons), pulmonary embolism (61.7 events per 100,000 persons), and intracranial hemorrhage (7.6 events per 100,000 persons).

* The researchers pointed out that “the effects of vaccination and of SARS-CoV-2 infection were estimated with different cohorts. Thus, they should be treated as separate sets of results rather than directly compared.”

RSV cases are too high and too early this year

August 23, 2021

Cases of respiratory syncytial virus (RSV) have been on the rise this summer, which is unusual given that RSV typically strikes in November and peaks in December/January. This unexpected increase prompted officials with the Ohio Department of Health to hold a briefing today discussing the rise in this common respiratory virus that typically produces mild, cold-like symptoms. Unlike the seasonal flu, which is caused by the influenza virus and has an annual shot available for protection, there is no RSV vaccine at this time. However, researchers have been working to develop one.

According to Ohio Department of Health Director Dr. Bruce Vanderhoff, it is not uncommon for children to be infected with two respiratory illnesses at one time and there have already been national reports of children simultaneously developing RSV and COVID-19. Not enough is yet known about the impact of having both viruses together and whether having COVID-19 can worsen the course of RSV.

Pfizer-BioNTech COVID-19 Vaccine receives full FDA Approval

August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.”

Moderna filed its requests for full approval after Pfizer, and Johnson & Johnson is expected to go through the same steps in the coming months.

AstraZeneca announces non-vaccine COVID prevention therapy with 77% efficacy

August 20, 2021

AstraZeneca just announced that they’ve developed a non-vaccine therapy, called AZD7442, which reduces the risk of developing COVID-19. This combination of two long-acting antibodies* (LAAB) is administered intramuscularly and was found to cut the risk of developing symptomatic COVID-19 by 77% compared to placebo in the clinical trial.

The trial included 5,197 unvaccinated participants and more than 75% had comorbidities, including those with immunosuppressive disease or taking immunosuppressive medications, diabetes, severe obesity or cardiac disease, chronic obstructive pulmonary disease, chronic kidney, and chronic liver disease.

* AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by recovering patients after SARS-CoV-2 virus infection.

Increase in JIA flare-ups seen during COVID lockdown in Italy

August 19, 2021

This week, a team of researchers reported online in Arthritis Care & Research that the rate of disease flares among juvenile idiopathic arthritis (JIA) patients* increased from 6.3% in 2019 to 16.9% in 2020. The elevation was seen even though the patients had adhered to their medication regimens and had been in a state of inactive disease.

While a small handful of researchers have been studying the pandemic’s effects on adults with autoimmune and inflammatory diseases, very little is known about the specific impact on pediatric patients. This gap in the research is what inspired this team of researchers to focus on this specific population. The researchers noted that “the physical inactivity associated with home confinement could be a possible explanation for clinical worsening in our patients” and emphasized the need for implementing personalized at-home exercise plans for JIA patients confined to their homes.

* A single-center retrospective study was conducted, including patients presenting inactive JIA between September 1st, 2018 and March 9th, 2019 (group A – 126 patients) and between September 1st, 2019 and March 9th, 2020 (group B – 124 patients).

Wildfire smoke exposure + COVID-19 = double whammy for the immune system

August 18, 2021

A study published Friday in Science magazine explored a notable association between wildfire smoke exposure and the sizable number of COVID-19 cases and deaths in Oregon, Washington, and California in 2020. There are numerous compounds that make up wildfire smoke, but one of the most prevalent and dangerous is called PM2.5 (particulate matter measuring 2.5 micrometers or less). Due to its small size, PM2.5 can penetrate deep into human lungs, unlike larger pieces of particulate matter. Identified by the Environmental Protection Agency as a health threat, PM2.5 has been found to compromise the immune system, particularly by clogging up the upper respiratory system and by prompting an immune attack from the body following lung penetration. Researchers proposed that having to respond to this PM2.5 attack distracts and overwhelms the immune system, leaving it more vulnerable to a COVID-19 infection.

Immune Response and Disease Flares low in SLE Patients Following COVID-19 Vaccination

August 17, 2021

Recently, the results of a study focusing on patients with systemic lupus erythematosus (SLE) who were fully vaccinated against COVID-19 was published, making it the first study of its kind. The 90 SLE patients participating in the study were recruited from the NYU Lupus Cohort and were compared against a group of 20 healthy controls with no known rheumatological diseases. Controls had only received the Pfizer-BioNTech and Moderna vaccines, whereas SLE patients received all three vaccines in the U.S., which includes the Johnson and Johnson vaccine. Overall, nearly 30% of SLE patients had a lower immune response to the COVID-19 vaccine than the control group. The low levels of response to the vaccine were likely associated with taking non-antimalarial immunosuppressant medications.

In addition to immune response following vaccination, disease flares were also assessed in the study. Flares were low post-vaccination, with 11.4% of patients reporting a mild to moderate flare, and 1.3% having a severe flare. 

First dose of Pfizer vaccine increases antibodies in those with prior COVID-19 infection

August 16, 2021

A team of doctors affiliated with the Rush University Medical Center recently wrote a research letter summarizing recent findings on Pfizer’s COVID-19 vaccine. Notably, the investigators “observed higher SARS-CoV-2 antibody levels in previously infected individuals after 1 dose of [Pfizer] compared with infection-naive individuals after two doses.” The study also found that those previously infected with COVID-19 saw an increased antibody response after the first dose, but did not see another significant increase following the second dose.

Cognitive Consequences of COVID-19

August 15, 2021

A recent study conducted in the UK sought to confirm whether there was an association between cognitive performance data from 81,337 participants and COVID-19 case data.

Data included in the study were collected between January and December 2020, and participants completed an extended questionnaire (with questions pertaining to COVID-19 infection), as well as a series of cognitive tasks via The Great British Intelligence Test. Researchers found that people who had recovered from COVID-19, including those no longer reporting symptoms, “exhibited significant cognitive deficits” compared to those in the control group.

Notably, the severity of cognitive deficits was associated with the degree of illness severity from COVID-19 infection. Those who were hospitalized and placed on a ventilator exhibited the greatest deficits. These deficits were even larger than the deficits present in those who had previously suffered a stroke or had learning disabilities.

The most pronounced cognitive deficits detected in the study parallel the cognitive symptoms present in “long Covid.” These deficits presented themselves in tasks involving reasoning, spatial planning, target detection, and problem-solving.

FDA authorizes additional dose for immunocompromised patients

August 13, 2021

Last night, the FDA authorized use of an additional dose of Pfizer-BioNTech and Moderna’s COVID-19 vaccines for those who are immunocompromised and may not have developed sufficient antibodies after a full dose of the COVID-19 vaccine. These patients include those who have received solid organ transplants, as well as “those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”

The statement added that those who are fully vaccinated do not need an additional dose of the COVID-19 vaccine at this time. The FDA is currently assessing the need for a booster dose amongst the general population and will consider whether this is needed in the future.

On August 10, the NIH launched a study testing the efficacy of a third COVID-19 vaccine in kidney transplant recipients. This pilot study aims to identify characteristics that can help distinguish kidney transplant recipients who will benefit from a third dose from those who will need a different means of achieving full protection. “The pilot study findings will inform a subsequent, larger phase of the trial that includes higher-risk strategies to induce a protective immune response against SARS-CoV-2 in solid organ transplant recipients who do not respond to a third dose of an mRNA vaccine.”

The CDC’s Advisory Committee on Immunization Practices (ACIP) will be meeting today to discuss further recommendations for immunocompromised patients.

Using Infliximab to treat COVID-19

August 12, 2021

Yesterday, the WHO announced that three drugs are being tested as effective treatments for COVID-19. The trial will include infliximab, which is currently approved to treat autoimmune diseases such as Crohn’s diseaseulcerative colitispsoriatic arthritis, and rheumatoid arthritis.

So far, infliximab has shown decreased mortality risks for those infected with COVID-19 when used as a treatment, regardless of whether they have an autoimmune disease. In fact, one study found that its use helped drop mortality rates for hospitalized COVID-19 patients by 35%. Other studies have also noted a marked improvement for infected patients being treated with infliximab.

The NIH and Tufts Medical Center are currently conducting a Phase 2 clinical trial testing whether TNF inhibitors like infliximab reduce the need for respiratory support in severe COVID-19 infections.

The Effect of Anti-CD20 therapies on SARS-CoV-2 Immune Responses in Multiple Sclerosis Patients

August 11, 2021

Researchers in France investigated the humoral immune response to COVID-19 in patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMO-SD). Humoral immune responses use antibodies to protect against reinfection when exposed to a foreign invader.

The results of the study showed a high seroconversion rate in patients with MS and NMO-SD after COVID-19. However, patients treated with anti-CD20 therapies had a seroconversion rate twice as low as untreated patients and patients receiving a different treatment. In other words, patients treated with anti-CD20 therapies exhibited a weaker antibody response against a COVID-19 infection. Some factors found to influence seroconversion rates included IgG levels and severity of COVID-19 infection. The time between the last anti-CD20 infusion and COVID-19 was also longer in seropositive patients.

Antibody development following COVID-19 vaccine in autoimmune disease patients

August 10, 2021

A study coming from the Netherlands looks at the immune response following COVID-19 vaccination in patients with autoimmune disease, focusing specifically on the effects of different immunosuppressive drugs on antibody development. Researchers used serum samples from 289 patients without autoimmune disease, who served as the control group, and 632 patients with autoimmune disease (including rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematous and multiple sclerosis). The mean age of participants was 63 years and 57% of participants were female.

Serum samples were collected from participants after their first or second dose of the COVID-19 vaccine (to include Johnson & Johnson, Pfizer, AstraZeneca, and Moderna). “Among participants without previous SARS-CoV-2 infection, seroconversion after first vaccination were significantly lower in patients than in [the] control,” mainly due to the use of immunosuppressive therapies in autoimmune disease patients (namely, methotrexate or anti-CD20 therapies versus prednisone or TNF inhibitors). Seroconversion is the transition from viral infection to antibody presence in the body.

After the second dose, seroconversion surpassed 80% in all patients regardless of treatment, except those treated with anti-CD20 therapies. In this treatment subgroup, 3 of 7 patients exceeded 80% seroconversion. Seroconversion rates and antibody titers were similar across autoimmune disease types and vaccine types included in the study, “suggesting that treatment with immunosuppressive medication, rather than the underlying autoimmune disease, is the main factor that influences immunogenicity of vaccines.”

Researchers did not observe a difference in seroconversion and IgG antibody titers between patients with a previous COVID-19 infection who received one dose of the vaccine and patients without a previous COVID-19 infection who received both doses.

Researchers also stated that a second or repeated exposure to SARS-CoV-2 via infection improves immunity in patients on immunosuppressive therapies. This is an interesting remark as studies and clinical data suggest the autoimmune disease population is at increased risk of developing severe disease from a COVID-19 infection (1, 2, 3, 4). That being said, “delayed second dosing of COVID-19 vaccines should be avoided in patients receiving immunosuppressive drugs.”

While the results of this study are informative and provide clarity for the autoimmune disease population, further studies should be conducted with younger patients. Additionally, the study did not measure the timing of anti-CD20 therapy prior to vaccination.

Pending authorization of COVID-19 booster for immunocompromised population

August 9, 2021

Last Thursday during a White House briefing, Dr. Fauci stated the need for a booster shot in immunocompromised persons, as they are often unable to produce sufficient antibodies against COVID-19. Dr. Fauci stated that CDC and FDA officials are working to get this population an additional dose “as quickly as possible,” with speculations that this may be possible within the next few weeks.

This group includes those who have received organ transplants, chemotherapy patients, and those who are currently on other immunosuppressive therapies.

In a joint statement released last month, the FDA and CDC stated that “people who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta.” The need for boosters amongst the general population has not reached a consensus within the scientific community, and as of now the FDA, CDC, and NIH’s position remains that “Americans who have been fully vaccinated do not need a booster shot at this time.”

Vaccine manufacturers have reported high levels of protection against the Delta variant (1, 2, 3).

Rheumatic Flares Uncommon Following COVID-19 Vaccination

August 6, 2021

A recent study published by Arthritis & Rheumatology evaluated disease flares and post-vaccination reactions in patients with rheumatic and musculoskeletal diseases (RMD) following two-doses of an mRNA vaccine. The most common diseases amongst patients in the study were inflammatory arthritis (47%), systemic lupus erythematosus (20%), and mixed connective tissue disease (20%). Types of inflammatory arthritis include ankylosing spondylitis, psoriatic arthritis, and rhuematoid arthritis

Of the 1,377 participants given two doses of the vaccine, 11% reported flares that required treatment. There were no reports of severe flares. Moreover, no participant required intravenous therapy or hospitalization.

Factors associated with flares requiring treatment included a previous COVID-19 diagnosis, history of a flare 6 months before the first dose of the vaccine, and the use of combination immunomodulatory therapy. 

Post-vaccination reactions commonly reported included pain at the injection site and fatigue. Reactions were heightened after the second dose with systemic reactions such as headache, myalgia, fatigue, and chills. It should be noted that none of the patients reported cases of anaphylaxis or a newly diagnosed SARS-CoV-2 infection during the study period. 

Antibody response in IBD patients after COVID-19 infection

August 5, 2021

Canadian researchers at the University of Calgary have published a study testing the antibody response after a COVID-19 infection in those with inflammatory bowel disease (IBD).

Many IBD patients take immunosuppressive therapies for their autoimmune disease, which may inhibit the development of antibodies after a COVID-19 infection or the vaccine. This population is also considered high-risk for severe disease outcomes from a COVID-19 infection.

Serosurveillance provides estimates of antibody levels against infectious diseases and is considered the gold standard for measuring population immunity due to past infection or vaccination. This serosurveillance study included 324 patients from October 2020 to April 2021; 279 patients were in the serosurveillance group and did not have a prior COVID-19 diagnosis. 45 patients had been previously infected and recovered from COVID-19. The majority of participants had Crohn’s disease; 60% of recovered patients and 48.5% of the serosurveillance group were on anti-TNF agents.

At baseline, 53.3% of recovered patients had positive nucleocapsid antibodies, whereas 1.08% of the serosurveillance cohort tested positive. Nucleocapsid proteins are the most sensitive target for serologicical diagnosis of a COVID-19 infection; neutralizing antibodies appear later in immune development (1).

“The proportion of patients who were nucleocapsid antibody positive was 80.9% from 0-90 days from diagnosis.” Only 21.7% of patients tested positive for antibodies after 90 days post-infection.

Regeneron's antibody cocktail authorized for use as prophylaxis

August 3, 2021

Last Friday, Regeneron announced the FDA’s decision to expand the EUA for their antibody cocktail as a prophylaxis (action taken to prevent disease, especially by specified means or against a specified disease). Previously, it was authorized for non-hospitalized patients aged 12+ who tested positive for a COVID-19 infection and were at risk of experiencing severe disease.

In a Phase 3 trial, the cocktail reduced the risk of symptomatic infection by 81% when used as a post-exposure prophylaxis. This is the first monoclonal antibody treatment that can be used as both a treatment and prophylactic after exposure to COVID-19. The EUA applies to those 12+ who are exposed to someone with the virus, or through certain institutional settings.

“With this authorization, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mount an adequate response to vaccination, who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting.” It is estimated that approximately 3% of the U.S. may not respond to the COVID-19 vaccine due to certain health conditions or immunosuppressive therapies.

Regeneron noted the cocktail’s potency against the Delta variant in particular.

The Immunogenicity and Safety of the CoronaVac Vaccine in Patients with Autoimmune Rheumatic Diseases

August 2, 2021

Last Friday, Nature Medicine published the results of a Phase 4 trial on the CoronaVac vaccine, which took place in Brazil. This trial aimed to evaluate both the immunogenicity and safety of CoronaVac in 910 patients with autoimmune rheumatic diseases (ARD). Immunogenicity measures the ability of a vaccine to induce an immune response in someone who’s been vaccinated (1). In this particular study, immunogenicity was indicated by the presence of anti-SARS-CoV-2 IgG and neutralizing antibodies. The results found that the vaccine produced an immune response in patients with ARD, but at lower levels when compared to the control group.

Factors which contributed to negative anti-SARS-CoV-2 antibodies were older age and female sex. Old age was also more common among patients with negative neutralizing antibodies after complete vaccination.

In addition to immunogenicity, vaccine safety was explored as a secondary outcome in the study. Overall, there were no moderate or severe adverse events reported. General reactions such as back pain, nausea, joint pain, sweating, and fatigue were more frequently reported among the cohort. 

Breakthrough infections after Covid-19 vaccination

July 30, 2021

On Wednesday, the New England Journal of Medicine published a study evaluating data obtained from fully vaccinated healthcare workers at Israel’s largest hospital. The study focused on breakthrough Covid-19 infections, defined as detection of the SARS-CoV-2 virus via a RT-PCR test 11 or more days after receiving the second dose of the Pfizer vaccine. Of 11,453 vaccinated healthcare workers, 1,497 were tested for COVID-19 during the study, and 39 breakthrough infections were documented.

Of all the workers with breakthrough infection, 26 (67%) had mild symptoms at some stage, 13 were asymptomatic, and none required hospitalization.

The investigators of the study obtained antibody titers from 22 of the employees from before they were infected with SARS-CoV-2. Serological samples from breakthrough cases were matched with 4-5 samples from uninfected controls based on a series of factors (including age, sex, immunosuppression status, and the amount of time between receiving the second dose of the Pfizer vaccine to getting tested). The breakthrough cases showed lower levels of neutralizing antibodies. This is an important first step in discovering the threshold of neutralizing antibody protection that is needed to combat breakthrough infections.

Influence of sex hormones on long Covid

July 28, 2021

Recent scientific discussion has correlated Long Covid with estrogen-associated autoimmune disease

There has yet to be a consensus on the definition of “Long Covid.” That being said, it is widely acknowledged that Long Covid symptoms, including shortness of breath, persistent fatigue, brain fog, and GI disturbances, typically last more than 2 months after a COVID-19 infection. “Women appear to be twice as likely to develop Long Covid as men, but only until around age 60, when the risk level becomes similar.”

The authors of this article agree with the hypothesis that Long Covid from a SARS-CoV-2 infection can trigger an autoimmune reaction, “perhaps due to molecular mimicry with some components of our body… the autoimmune hypothesis could justify the higher incidence of this syndrome in women.” Read more about the autoimmune connection to COVID-19 here.

The authors also point out the immune response for genetic and hormonal factors are a “double-edged sword:” men account for higher rates of acute COVID-19 compared to women, whereas autoimmune reactions are more prevalent in women overall.

Specifically targeted research is necessary to better understand this connection, and can start with studying the specificity of autoantibodies in patient serum to create sex-specific treatments for Long Covid. Moreover, studying larger cohorts of Long Covid patients will enable researchers to identify trends within symptoms between the sexes.

Clinical research supports efficacy of COVID-19 booster for immunocompromised patients, federal authorization expected to follow

July 27, 2021

During an Advisory Committee on Immunization Practices (ACIP) meeting last week, CDC staff confirmed that a third dose booster may be on the horizon for those who are immunocompromised. This comes after promising data of a third dose eliciting a robust immune response in those who had previously received a full dose of the COVID-19 vaccine, but were unable to produce detectable antibodies.

The meeting referenced a study of 99 solid-organ transplant patients who received a third dose. In the study, the prevalence of anti–SARS-CoV-2 antibodies was 4% after the first dose, 40% after the second dose, and 68% 4 weeks after the third dose. 

“Among the 59 patients who had been seronegative (no presence of virus in blood serum) before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose.” Patients who did not elicit an antibody response were typically older, with a higher degree of immunosuppression, and a lower rate of kidney function.

No serious adverse events were reported by the cohort.

As of now, the use of a third dose would require a separate Emergency Use Authorization by the FDA. Once vaccines are FDA approved, doctors will be able to prescribe a booster to patients directly. Until then, patients may be able to access a third dose through investigational studies; some patients have also taken it upon themselves to obtain a third dose.

EMA authorizes the use of Moderna’s COVID-19 vaccine in children 12+

July 26, 2021

This past Friday, the European Medicines Agency (EMA) authorized the use of Moderna’s COVID-19 vaccine in children 12+ years of age. This will be the second vaccine manufacturer to be authorized for use in those 12+, alongside Pfizer. Children will be given two shots, four weeks apart, which is the same dosing schedule for adults.

The European Commission will take next steps to approve if and when the vaccine will be used in each of the E.U.’s countries. As of now, more than a dozen E.U. countries have been vaccinating children between the ages of 12 and 17 with the Pfizer vaccine.

The EMA’s decision was influenced by an ongoing pediatric study involving 3,732 children (2,163 of which received the vaccine and 1,569 receiving a placebo) showing that the Moderna vaccine “produced a comparable antibody response in 12 to 17-year-olds to that seen in young adults aged 18 to 25 years (as measured by the level of antibodies against SARS-CoV-2).” None of the 2,163 children who received the COVID-19 vaccine contracted the virus.

The Committee for Medicinal Products for Human Use (CHMP) noted that, at this time, “due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart).”

Are pericytes how the coronavirus can sneak past the blood-brain barrier?

July 23, 2021

Research and clinical observations have shown that the central nervous system (brain and spinal cord) is directly or indirectly affected by SARS-CoV-2 infection, though there has been no evidence of the virus infecting nerve cells themselves. In this recent study, an artificially grown mass of cells was created, mimicking a brain, and was infected with the coronavirus. The “cortical brain organoids” remained impervious to COVID-19. However, knowing that autopsy studies have shown that SAR-CoV-2 has the potential to spread throughout the brain, the researchers pressed on.

The main function of pericytes is to regulate blood flow in the brain, help maintain homeostasis within the body, and sustain the blood–brain barrier. What made these cells of particular interest to the researchers is that pericytes, unlike most neural cells, have high expressions of ACE2, the surface protein that SARS-CoV-2 uses to enter and infect cells. The researchers attempted to infect the cortical brain organoid again with the coronavirus, only this time they added pericytes, and an incredibly robust infection occurred. They found that the pericytes acted like ‘viral replication hubs’ following infection, allowing the virus to multiply and begin targeting astrocytes (immune cells crucial for several protective and regulatory functions in the brain). The researchers stated that the findings suggest that pericytes could potentially serve as an entry point for SARS-CoV-2.

Covid-19 vaccination in patients with SLE

July 22, 2021

Patients with systemic lupus erythematous (SLE) were excluded from COVID-19 vaccine trials. To better understand the tolerability of COVID-19 vaccines amongst patients with SLE, the international vaccination against COVID in systemic lupus (VACOLUP) study was initiated via online survey. Participants included those with a self-reported, medically confirmed diagnosis of SLE.

The study included 696 participants from 30 countries. All patients had received at least one dose by the time of the study, most commonly from Pfizer, Sinovac, AstraZeneca, and Moderna. 343 patients received a second dose.

316 participants reported side effects after the first dose; 181 of the 343 patients who received the second dose reported side effects. “Patients who received both vaccine doses and reported side-effects after the first dose were more likely to report side-effects after the second dose.”

3% of study participants reported a medically confirmed flare-up of SLE. “Having a flare during the past year before vaccination was associated with an increased risk of SLE flare after COVID-19 vaccination.” Approximately 50% of patients with SLE reported side effects that, more often than not, did not impair daily function. There was no difference in occurrence between those who received an mRNA vaccine versus a vaccine with a different method of delivery.

It is important to note that the short median time between vaccination and onset of flare-ups suggests that these side effects may parallel expected post-vaccine reactions, and that the “3% figure could be an overestimation of the actual flare rate.”

Breakthrough cases of COVID-19 in those who are immunocompromised

July 21, 2021

The European Society of Clinical Microbiology and Infectious Diseases published the results of a retrospective study of 17 hospitals throughout Israel. The study included 152 patients who tested positive for COVID-19 after being fully vaccinated with the Pfizer vaccine (breakthrough cases) and required hospitalization. This study aimed to “characterize vaccinated patients with breakthrough COVID-19 requiring hospitalization and define the main risk factors associated with poor outcomes in this group.” Notably, 40% of breakthrough cases included patients who were immunocompromised. 

Real-world data coming from Israel’s mass vaccination campaign parallels Phase 3 clinical trial data, supporting Pfizer vaccine’s 95% efficacy rate. That being said, efficacy was shown to be lower in those with multiple comorbidities and the immunocompromised. The most common causes of immunosuppression included chronic corticosteroid treatment, antimetabolite therapy, and anti-CD20 treatment (Rituximab, commonly used to treat rheumatoid arthritis, is an anti-CD20 biologic agent).

Overall, “comorbidities were more common in patients with vaccine breakthrough infections compared with large case series on unvaccinated hospitalized patients.” This reconfirms the hypothesis that the vaccine elicits a lower efficacy rate amongst those with certain comorbidities, especially if they are on immunosuppressive therapies. “Immunosuppression was not associated with a worse outcome, except for anti-CD20 treatment, which had a threefold higher odds ratio to be in the poor outcome group (13% versus 4%).” The overall mortality rate amongst these cases paralleled unvaccinated hospitalized COVID-19 patients.

Anti-NET autoantibodies may be a factor in severe covid-19

July 20, 2021

Recently, a study was published in which samples from 328 COVID-19 patients were measured for an autoantibody presence which protects neutrophil extracellular traps (NETs) from being destroyed.

NETs are extracellular webs of DNA and proteins that protect against infection, and have been implicated in the pathology of many immune-mediated diseases, including lupus, rheumatoid arthritis, and ANCA vasculitis.

Anti-NET antibodies disrupt the body’s ability to achieve immune homeostasis during a COVID-19 infection. These antibodies are also likely to contribute to the inflammatory storm which leads to severe COVID-19, including blood clots. Patients with increased levels of anti-NET antibodies were less likely to disintegrate the toxins, as the anti-NET antibodies coat the NETs, creating a barrier for the body to rid itself of the toxins. Additionally, patients who required ventilation had a “greater burden of anti-NET antibodies” than those whose symptoms did not require oxygen supplementation.

Anti-NETs have also been found in those with antiphospholipid syndrome, and present similar outcomes as COVID-19 patients. It is unknown how the body creates these autoantibodies; further studies may shed light on the persistence behind many long COVID symptoms, as well as the pathology of autoimmune disease.

Johnson & Johnson add autoimmune adverse reaction to COVID-19 vaccine warning label

July 13, 2021

Yesterday, Johnson & Johnson COVID-19 vaccine supplier Janssen Biotech, Inc. released a statement regarding the potential risks of their adenovirus vaccine. The updated disclaimer states:

“The reporting rate of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine has been highest in females ages 18 through 49 years; some have been fatal.”

This edit was meant to clarify the current understanding around the risk of clotting in females 18-49 years old. The notice also featured a new warning regarding the vaccine’s ability to trigger Guillain-Barré Syndrome (GBS) in recipients. GBS is an autoimmune condition where the body attacks its own nerve cells, causing muscle weakness and, sometimes, paralysis. Learn more about GBS here

It is important to note that GBS is typically triggered by a viral infection, and most people fully recover. 

In their recent press release, Janssen Biotech, Inc. explained that there are increased (but still very low) risks of developing GBS in the 42 days that follow vaccinations. VAERS cases were typically reported by males over 50 years of age, within two weeks of vaccination. The report recommends that those who are experiencing tingling in their legs or arms, troubles walking, or other symptoms seek medical attention immediately. 

Interestingly, the statement also noted that adverse reactions following vaccination are reported voluntarily. Preliminary reports have concluded that only about 8 people per million of those who had been vaccinated with the Johnson & Johnson vaccine experienced problems with GBS. This means that the frequency of reactions like the onset of GBS and blood clotting have still yet to be pinpointed as casual relationships. For this reason, Johnson & Johnson and the FDA consider this vaccine to be safe, and that the risks of COVID-19 infection outweigh the risks of the vaccine’s potential side effects at this time. 

Israel begins Pfizer booster shots for immunocompromised, including those with autoimmune disease

July 12, 2021

Israel is now the first country whose Ministry of Health is officially recommending the use of booster shots for those with compromised immune systems, who may be unable to develop sufficient antibodies after a full dose of the vaccine.

The majority of those currently hospitalized in Israel for COVID-19, who have already been vaccinated, include those in high risk groups. While organ transplant patients take priority for a third shot, people with autoimmune disease will be eligible.

Independent clinical cases have already shown an uptake in antibody production after a third dose in those who are immunocompromised. The Israeli government has not come to a decision regarding booster shots for the general population.

What makes COVID-19 affect people differently?

July 9, 2021

A study published yesterday in Nature, called Mapping the human genetic architecture of COVID-19, suggests that genetics may be the answer.

This is the biggest single genetic study in history looking at how the variances in DNA amongst individuals around the world respond differently to a virus. Researchers were able to identify and confirm 13 genes that seem to play a part in determining susceptibility to becoming infected as well as the severity of the infection. Some genes, particularly ones involved with lung-related phenotypes or autoimmune/inflammatory diseases, directly correlated with common coronavirus symptoms; other genes will require more investigation. Researchers are also hoping to use this information to investigate why some individuals develop long COVID while others don’t.

Clinical trial to commence testing COVID-19 booster shot in participants who are immunocompromised and living with autoimmune disease

July 6, 2021

Pfizer is planning a clinical trial on the efficacy of a third vaccine to boost the creation of antibodies in immunocompromised individuals. This trial will include 360 participants who are ages 2+ and immunocompromised (to include those on immunomodulator therapy for an autoimmune disease).

Those on immunotherapies are particular vulnerable to complications due to COVID-19 infection; however, this population group is often unable to produce detectible antibodies after a full dose of the COVID-19 vaccine. This will be the first study including those who are immunocompromised or living with an autoimmune disease to see if antibody production increases after a third dose of the COVID-19 vaccine. Clinical observations of patients getting a third dose show seemingly impressive antibody production, but must be considered on a case-by-case basis.

Around 5% of the US population is considered to be immunocompromised. While organ transplant and cancer patients have been a focus of COVID-19 and vaccine research, those taking Rituximab, corticosteroids and methotrexate – often taken by those living with certain autoimmune diseases – may be resistant to protection from the COVID-19 vaccine.

The clinical trial is estimated to begin September 2021 and conclude January 2023.

FDA Fact Sheets have been updated to include risk of Myocarditis and Pericarditis Following Covid vaccine

June 29, 2021

Last week, the CDC Advisory Committee on Immunization Practices convened to discuss the uptake in myocarditis and pericarditis cases in young adults following a COVID-19 vaccination. During the advisory meeting, it was stated that there was a “likely association.” FDA Fact Sheets have since been updated to include the risk of developing myocarditis and pericarditis, particularly following a second dose of the mRNA vaccine

The CDC Advisory Committee meeting was organized as over 1200 cases of myocarditis have been reported in young persons 30 years and younger. Because 300 million doses have been administered thus far, cases of myocarditis and pericarditis are still considered a rare adverse event. 

The majority of cases were presented in males, most often one week after the second dose; chest pain was the most common reported symptom. It was emphasized that heart inflammation and heart function are separate, and that heart inflammation was reduced with prescription medications, over-the-counter medications, or resolved on their own. It should also be noted that close to 1600 young athletes have undergone a cardiac MRI following a SARS-CoV-2 infection. 

It was recommended that those who experience myocarditis following their first dose should wait until symptoms resolve completely before receiving a second dose of the vaccine. Additionally, it was stated that the risk of side effects following an mRNA vaccine do not outweigh their benefits within this age group, as post-Covid conditions often pose a greater risk in children, such as the development of MIS-C. 

4,018 MIS-C cases have been reported as of June 2, 2021, with 60-70% of patients being admitted into the ICU. 12-20 year olds account for 36% of cases. 

mRNa vaccine may produce long-lasting immunity to SARS-CoV-2

June 28, 2021

New research indicates that mRNA vaccines may produce long-lasting immunity. This morning, the medical school at Washington University of St. Louis released results from a study showing that the immune response to the Pfizer vaccine continued at high levels 15 weeks post-vaccination

Additionally, patients vaccinated with the Pfizer and Moderna vaccines produced high levels of antibodies three weeks after their first dose, which are effectively able to neutralize three strains of the SARS-CoV-2 virus. This response was even higher in those previously infected with COVID-19 and then vaccinated. 

This is the first study to show evidence of prolonged B cell production in germinal centers post-vaccination. Germinal centers are created within the lymphoid tissue and create memory B cells. The longer a germinal center remains active, the stronger the immune response will be. Once antibodies are created, they flow into the bloodstream. 

The study’s researchers sampled the germinal centers in the lymph nodes of 14 vaccinated patients, three weeks after the first dose. Samples were obtained at the four, five and seven week marks as well. 10 participants gave samples 15 weeks after their first vaccine. 

In the three-week sample, all 14 participants had formed germinal centers that were producing antibodies against SARS-CoV-2. This immune response peaked after the booster and decreased (yet remained detectable) at the 15 week mark.

Studies have found that antigen-specific B cells can persist for at least one year, though it should be noted that studies on the extended durability of vaccine-induced antibody responses are rare. “The persistence of S-binding germinal center B cells and plasma blasts in draining lymph nodes is a positive indicator for induction of long-lived plasma cell responses.”

“Future studies will be needed to examine whether mRNA vaccination induces a robust S-specific long-lived plasma cell compartment in the bone marrow.” It has been previously shown that a COVID-19 infection does in fact produce B cells which remain dormant in bone marrow. Further studies will elucidate the influence of a previous COVID-19 infection on germinal centers compared to vaccine-induced germinal center responses. 

Questions surround rare development of GBS after Covid-19 vaccination

June 25, 2021

Recently, reports have been published associating adenovirus vector COVID-19 vaccines and the onset of unusual variants of Guillain-Barré syndrome (GBS). Notably, experts highlight that there have been no findings suggesting COVID vaccines cause GBS. However, the timing of the condition’s onset occurring shortly after vaccination has raised questions among researchers. 

Within the past month, there have been three different reports linking the AstraZeneca and Johnson & Johnson adenovirus vector COVID-19 vaccines to unusual variants of GBS. Two studies published in the Annals of Neurology on June 10, 2021, linked the development of GBS with the AstraZeneca vaccines in Nottingham, England, and Kerala, India, and involved both men and women. Additionally, during a clinical trial, a woman with a history of migraines who had received the Johnson & Johnson vaccine experienced GBS-like symptoms but recovered after being treated for GBS.  

In each study, researchers found the cases to develop in people 10-22 days after their vaccination. This time period coincides with the maximal immune response to the vaccine,  the point at which the vaccine becomes fully effective. Traditional forms of GBS are characterized by muscle weakness and, sometimes, paralysis following infection with a virus or bacteria. Interestingly, reports of facial weakness were less common in these cases when compared to traditional GBS cases.

Cases of GBS have been reported to VAERS after vaccination with Moderna and Pfizer vaccines as well. While rare, reporting adverse events to VAERS notifies the CDC and FDA on which adverse events to investigate further. 

Can a SARS-CoV-2 Infection Trigger Celiac Disease?

analysis of remaining long-covid symptoms following recovery of initial infection

June 18, 2021

FAIRHealth published its eighth white paper study on COVID-19 this past Tuesday. This iteration of the report detailed findings regarding the experiences of long-haul COVID patients who were 30 days or more removed from their initial COVID-19 diagnosis. 

One key finding identified that 23.2% of patients who had COVID-19 experienced at least one post-COVID condition. Moreover, the severity of one’s COVID-19 case seemed to play a role in one’s susceptibility to long-haul COVID conditions. Regardless of whether a person was hospitalized or experienced no symptoms, at least some portion of those who had COVID-19 were found to be susceptible to developing long-haul COVID conditions. Specifically, 50% of patients were hospitalized for their COVID-19 symptoms, 27.5% of those who were symptomatic but not hospitalized, and 19% of asymptomatic patients developed a post-COVID condition.

The most common post-COVID conditions for these individuals across every age group included pain, difficulties breathing, hyperlipidemia, malaise and fatigue, and hypertension. In more refined sample populations, there were some notable variances. Specifically, there were some slight variations between the different age groups. For example, the pediatric population (those between 0 and 18) had intestinal issues as the third most common post-COVID condition rather than hyperlipidemia. 

The study also focused on the mental health implications of COVID-19. Four different mental conditions were also a focal point of the study. The research found that anxiety cases were the most common out of the four, with depression, adjustment disorders, and tic disorders following.

Notably, females were generally more affected by long-COVID conditions than males were, except for 12 specific conditions (including post-COVID cardiac inflammation). 

Mortality rates were the final focus of the long-haul COVID patient study. With this lens, researchers found that the severity of one’s COVID-19 experience played a role in their likelihood of surviving following 30+ days after their initial diagnosis. Specifically, the study found that those hospitalized and later discharged were 46 times more likely to die than those who had never been hospitalized. Additionally, those with intellectual disabilities who suffered from COVID-19 were the most likely group out of all preexisting conditions to die 30+ days after their COVID-19 diagnosis.

REGEN-COV Phase 3 Trial Improves Survival in Patients Hospitalized with Severe COVID-19

June 17, 2021

A Phase 3 RECOVERY trial in the UK found that Regeneron’s REGEN-COV antibody treatment reduced the risk of death by 20% in patients who had not mounted their own immune response against COVID-19. In addition, among patients without their own immune response, the median duration of hospital stay was 4 days shorter in the REGEN-COV group, and there was a greater proportion of patients discharged by 28 days. Research has also shown that the treatment remains effective against the main variants of COVID-19 in the United States. 

REGEN-COV is a mix of two monoclonal antibodies known as casirivimab and imdevimab. These antibodies block the infection ability of SARS-COV-2, the virus that causes COVID-19.

The results of the RECOVERY trial demonstrate that REGEN-COV can “alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital.” Regeneron is working with the FDA to expand its current EUA to other populations such as hospitalized patients.

Safety, Immunogenicity and Efficacy of the Pfizer vaccine amongst 686 patients with Autoimmune inflammatory rheumatic diseases

June 16, 2021

Israel has been a model for vaccination success against COVID-19, with over 56% of the country being fully vaccinated. On Monday, June 13, Israeli researchers published the findings of the largest observational prospective study confirming the immunogenicity, efficacy, and safety of the Pfizer vaccine amongst 686 patients with autoimmune inflammatory rheumatic diseases (AIIRD). 

Rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus (SLE), systemic vasculitis, Behcet’s disease, and Susac syndrome were included under the umbrella of AIIRD. Patients were instructed to continue all medications besides rituximab (pending physician’s recommendations). 

Healthcare providers made up the majority of the control group (121 participants), and all participants were given a complete dose of the Pfizer vaccine three weeks apart. Post-vaccination status and activity were assessed within 2-6 weeks following the second dose.

While the immunogenicity rates (immune response towards a vaccine over a long period of time) amongst those on immunosuppressive therapies such as rituximab and glucocorticoids were lower than average, there were no post-vaccination symptomatic COVID-19 cases amongst those with AAIRD. This data is concurrent with available data recorded in the US and short-term efficacy research published by the American College of Rheumatology.

The prevalence of adverse events was also similar between patients with AIIRD and the control group. Post-vaccination disease remained relatively stable in the majority of patients with AIIRD, and adverse events were typically mild in nature. Major adverse events included herpes zoster (6 cases), uveitis (2), pericarditis (1), and two deaths several weeks after receiving the second dose. 

AIIRD patients exhibited a reduced antibody production rate of 86% following the vaccine compared to 100% in controls. Patients with psoriatic arthritis, axial spondyloarthritis, systemic lupus erythematosus (SLE), and systemic vasculitis demonstrated a seropositivity rate (positive serum reaction when testing for antibodies) above 90%. The seropositivity rate amongst patients with rheumatoid arthritis was 82.1%. “The seropositivity rate in patients vaccinated within 6 months after rituximab treatment was below 20% but increased to about 50% in patients vaccinated 1 year after rituximab treatment.”

Treating MIS-C with Phase 3 Celiac drug

June 15, 2021

Even after a COVID-19 infection has passed, SARS-CoV-2 particles may linger in the gut and make their way into the bloodstream. This often triggers a cytokine storm and hyper-inflammatory response (MIS-C) within multiple areas of the body. These include the heart, lungs, kidneys, brain, and GI organs. 

A new study published in the Journal of Clinical Investigation focuses on the role of SARS-CoV-2 particles in the gut as the root cause of MIS-C weeks to months after a COVID-19 infection. The study tested the stool of 100 children, 19 of which had MIS-C and 26 who tested positive for a COVID-19 infection. 55 children served as healthy controls. 

18 of the 19 children who developed MIS-C had high levels of the SARS-CoV-2 virus in their stool. They also presented with high levels of zonulin, a protein that regulates the permeability of the digestive tract. “Increased circulating zonulin levels resulting in increased intestinal permeability have been reported in several diseases including auto-immune and hyper-inflammatory diseases such as celiac disease, inflammatory bowel disease, and Kawasaki disease.” 

Investigators obtained permission to treat one patient with Larazotide – a zonulin antagonist that strengthens the gut barrier and is currently in Phase 3 clinical trials for use in celiac patients. “Inhibition of intestinal permeability in a patient with MIS-C prevents SARS-CoV-2 antigens from trafficking into the bloodstream, conferring clinical benefit by addressing the underlying trigger for MIS-C rather than just the inflammatory consequences.” Researchers from this study are planning to conduct a clinical trial using Larazotide to treat MIS-C. They will use this as a starting point for the development of an effective treatment or even prophylaxis for COVID-19 infections amongst children.

Targeted COVID-19 therapy: What can we learn from autoimmune kidney diseases?

June 10, 2021

A study was recently published on the ability of antiphospholipid antibodies (aPLs) to bind to the “EPCR-LBPA” complex. Antiphospholipid antibodies are autoantibodies that target and attack phospholipid-binding proteins. This, researchers found, initiates a self-amplifying signaling loop related to the innate immune complement and coagulation pathways. 

The EPCR-LBPA complex contains lipid-proteins that are located on the interior of blood vessels involved in the innate immune and clotting systems. The complex activates in the face of antiphospholipid antibodies, and has been found to be involved in severe COVID-19 and systemic lupus erythematosus (SLE) cases. Once activated, the body’s inflammatory pathways and the primary pathway for blood coagulation are initiated. This initiation results in the exponentially increased production of autoantibodies as immune cell and B cell synthesis increases. 

This finding by the German-based research group has proved notable, particularly because of its implications for treating both SLE and COVID-19 patients. Specifically, the study group found that blocking the EPCR-LBPA signaling pathway in mice subjects helped prevent aPL-related blood clotting and an autoimmune response, further illuminating a potential treatment path for human patients. 

Oxford-AstraZeneca vaccine found to be associated with small risk of developing rare autoimmune blood disorder

June 9, 2021

A new study, published today in Nature, has reported the observance of a slightly increased risk of developing immune thrombocytopenic purpura (ITP) following inoculation with the Oxford-AstraZeneca vaccine. ITP is a rare autoimmune condition that results in excessive bruising or bleeding due to a decrease in the number of platelets in the blood.

The study looked at 2.53 million adults in Scotland who received their first doses of either the Oxford-AstraZeneca or Pfizer-BioNtech vaccine. There was no increased risk of blood disorders observed with the Pfizer-BioNtech vaccine. However, the Oxford-AstraZeneca vaccine risk of developing ITP was estimated at 1.13 cases per 100,000 people*. Risk factors found to be associated with developing post-vaccination ITP and other blood disorders included older age, male sex, smoking, and having other underlying conditions. 

* This very small risk is important but needs to be seen within the context of the overall benefits of receiving the vaccine for most people. ITP is still a very rare vaccine-induced adverse event and researchers plan to update their analysis as the vaccine program is extended to a larger demographic.

Can Vitiligo protect against the SARS-CoV-2 virus?

June 8, 2021

The Amsterdam Institute for Infection and Immunity has released a research proposal hypothesizing that non-segmental vitiligo, an autoimmune skin disorder, may protect against the SARS-CoV-2 virus developing into a COVID-19 infection.

The researchers hypothesize that vitiligo could lower the risk for COVID-19 development and clear the viral infection more efficiently. “Conversely, in case of COVID-19 development, vitiligo autoimmunity may influence the cytokine storm-related disease burden.” There is also a potential for a COVID-19 infection to increase vitiligo flare-ups, or increase the activity of the autoimmune condition. Read more about the influence of cytokine storms in the development of autoimmune disease in our article. 

Protection against COVID-19 relies on both innate and adaptive immunity. Patients with vitiligo display both adaptive and innate immune responses which, according to the study’s researchers, can result in clearing COVID-19 infections. To test this hypothesis, the researchers propose reviewing patient data registries while also employing a questionnaire study amongst patients with vitiligo and controls. Participants will range from ages 16-55, and the study will account for gender differences and co-morbidities with other autoimmune diseases in its analysis. “Since the history of autoimmune co-morbidities of both vitiligo patients and controls is also collected, we can subsequently determine the effect of other frequently found autoimmune diseases on COVID-19 disease development and severity.”

Due to the high prevalence of vitiligo worldwide, the study will be conducted internationally. 

Data from 1,500 rheumatic disease patients shows vaccine is well tolerated

June 7, 2021

Data recently sourced from the European League Against Rheumatism (EULAR) shows that the COVID-19 vaccine is well tolerated amongst patients with rheumatic disease. The registry was launched February 5, 2021, and includes reports from 28 countries across Europe. 1,519 patients were reported to the registry as of April 27, with close to two-thirds being from women. To learn why women experience side-effects from vaccines more often than men, check out our article. 

“The majority (91%) had inflammatory RMDs [rheumatic and musculoskeletal diseases]. Inflammatory joint diseases accounted for 51% of cases, connective tissue diseases 19%, vasculitis 16%, other immune mediated inflammatory diseases 4%, and non-inflammatory/mechanical RMDs 9%.” Reports of side effects were submitted most often from patients living with these common diseases: rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, and axial spondyloarthritis.

Potential vaccine side effects were reported by 31% of patients included in the registry, while disease flares – to include arthritis, joint pain, cutaneous flare, and fatigue – occurred in 5% of patients. 1.2% were labeled as severe flares. Mild symptoms included fatigue, headache, muscle pain and most commonly, pain at the injection site. 

Overall, experts are reassured by these safety profiles, as the majority of adverse events were similar to the general population, short-term and mild in nature. 

Covid-19 infection may lead to influx of autoantibody production

June 4, 2021

Yesterday, The University of Birmingham published the results of a study investigating the autoimmune response of COVID-19 patients. More specifically, researchers explored the type and frequency of autoantibody production in both short and long-term symptoms. Autoantibodies – antibodies produced by the immune system that can cause autoimmune disease by targeting one or more of the body’s own proteins – have recently been of particular interest to researchers looking into COVID-19. To learn more about autoantibodies in the development of autoimmune diseases, check out our article. 

Graphic explaining role of autoantibodies in autoimmune disease and covid-19utoantibodies in AD and COVID-19

In their study, researchers split test subjects into four cohorts to compare the common autoantibodies produced in COVID-19 patients versus non-COVID-19 patients. The first cohort consisted of a control group of non COVID-19 patients in the intensive treatment unit (ITU). The other cohorts included patients with acute cases of COVID-19 in the ITU and patients with previously severe cases of COVID-19 who had since left the ITU. The final test group included patients with mild cases of COVID-19 who had not been admitted to the ITU. For each of these groups, the researchers tested patient samples for specific autoantibodies. 

The study, supported by the National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI), found that COVID-19 patients had significantly more autoantibodies than those in the control group. The subgroups of COVID-19 patients who exhibited severe active or recovered cases also demonstrated significantly more frequent instances of possessing autoantibodies than the control group. Mild cases exhibited autoantibodies in their system less frequently but still more than the control group.

These findings imply that COVID-19 cases are still open-ended and do not necessarily resolve when patients are no longer contagious.

Immunocompromised patients exhibit low antibody response even after 2 doses of mRNA vaccine

June 3, 2021

This past March, results of a study monitoring the immune response to the COVID-19 vaccine in solid organ transplant patients indicated that antibodies were detected in only 17% of patients after the first dose of an mRNA vaccine. Since then, data from the same study has been published on the antibody response to the second dose of an mRNA vaccine in immunocompromised persons. Among 658 participants who received two doses of an mRNA vaccine, 15% had measurable antibody response after dose 1 and dose 2. Among 473 participants on antimetabolites, 8% exhibited an antibody response after dose 1 and dose 2. 

“Poor humoral response was persistently associated with use of antimetabolite immunosuppression.” Unfortunately, this may mean that immunocompromised individuals, even after taking a full dose of the vaccine, will not exhibit protective immunity to SARS-CoV-2. “Although no threshold has been established for protective immunity, antibody levels were well below that which has been observed in immunocompetent vaccines.” To read more about how people living with autoimmune disease and taking medications with antimetabolites may be affected by the vaccine, check out our Vaccine and Autoimmune Disease FAQ page and recommendations for those with specific autoimmune diseases.

“If someone had no, or limited, immune response to two doses, will a third dose help? Should the third dose be of the sample platform or a different platform? Is it reasonable for some patients to reduce immunosuppression, risking rejection, just to achieve an immune response? How do B cell and T cell responses look in immunosuppressed people?” These are some questions the National Vaccine Research Study for Transplant Recipients hope to answer, which is ongoing and currently still open for enrollment.

The NIH begins trial on mixing Covid-19 vaccine boosters

June 2, 2021

A trial funded by the NIH has entered Phase 1/2 testing to study COVID-19 vaccine boosters from different manufacturers on fully vaccinated adults

While it has not been determined whether boosters will be necessary, Dr. Fauci has stated that “we need to prepare for the possibility… to counter waning immunity and to keep pace with an evolving virus” (1).

The trial includes 150 participants who have been fully immunized with either the Johnson & Johnson, Moderna, or Pfizer vaccine. “Twelve to 20 weeks following their initial vaccination regimen, participants will receive a single booster dose of the Moderna COVID-19 vaccine as part of the trial.” Those who have not been fully vaccinated are eligible to enroll as part of a separate cohort, in which volunteers will receive two doses of the Moderna vaccine and will receive a third dose of a vaccine 12-20 weeks later. 

“All trial participants will be followed for one year after receiving their last vaccination as part of the study,” and will provide blood samples to evaluate the antibody response to current and variant strains of SARS-CoV-2. The initial results are expected by the end of Summer 2021. 

This is the first US trial to test the effects of mixing vaccines, while the Com-COV study began earlier this spring. Com-COV is a “UK multi-centre, participant-masked, randomized heterologous prime-boost COVID-19 vaccination study,” monitoring the effects of mixing vaccine doses between AstraZeneca, Pfizer, Moderna, and Novavax (2). 

While participants are experiencing higher rates of adverse events, the vaccine is still being deemed safe as the side effects are not severe. Reported side effects include fever, chills, headache, fatigue, joint pain, malaise, and aching muscles. Symptoms have reportedly been “short lived, and there [are] no concerns from the limited hematology and biochemistry data available.”

Preliminary data shows that those vaccinated with both the AstraZeneca and Pfizer vaccines are producing robust antibodies to SARS-CoV-2. Studies incorporating the Moderna and Novavax vaccines are also ongoing. Data around the primary immunological outcome is planned to be released in June 2021. 

Update June 3*

Canada has also instituted a new policy in which citizens may receive a Pfizer booster after one dose of the AstraZeneca vaccine. This is due to vaccine shortages across Canada; currently less than 6% of Canada’s population has been fully vaccinated.

The National Advisory Committee on Immunization also stated that Moderna and Pfizer vaccines may be used interchangeably between doses, although it’s recommended that people complete their vaccination schedule using the same manufacturer.

Research on lasting immunity to SARS-CoV-2

June 1, 2021

New research published in Nature has shown that immunity to SARS-CoV-2 can last from one year to possibly a lifetime, as a “SARS-CoV-2 infection induces a robust antigen-specific, long-lived humoral immune response in humans.”

The research, conducted at Washington University in St. Louis, studied participants who had been previously infected with COVID-19. Blood samples from 77 participants who experienced mild Covid infection were studied at three-month intervals starting at one month post-infection. Antibody levels declined sharply during the first four months and then steadily thereafter, and remained detectable at least 11 months post-infection. Bone marrow samples were also taken from 18 participants 7-8 months after infection, 15 of which exhibited memory B cells. 

“Bone marrow plasma cells are a persistent and essential source of protective antibodies,” and memory B cells contained in the bone marrow remain dormant and ready to produce antibodies in case of re-exposure to the virus. This may even include variants. 

Immune memory after fighting a live virus from natural infection is different to vaccine immunity, in which the body is exposed to a deconstructed viral protein. Those immunized 6-12 months post Covid-infection may have a different immune response than those who have not experienced infection and get immunized. Thus, boosters are not necessary for those previously infected with COVID-19 who have also been inoculated with a full dose of the vaccine. To learn more about how each dose of the mRNA vaccine produces separate antibody responses, check out our article.

6 month effects of Multisystem Inflammatory Syndrome in children

May 27, 2021

Multisystem Inflammatory Syndrome (MIS-C) is a hyper-inflammatory response occurring in children following COVID-19 infection. While more research has been conducted on the symptoms of this syndrome, not much is known about its long term impact on the overall health of children.

The Lancet Child and Adolescent Health Journal published a study giving closer insight into the long term effects of MIS-C. The study followed the outcomes of 46 adolescents with MIS-C (known as PIMS-TS in the United Kingdom) 6 months after being discharged from the hospital. All of the children included in the sample experienced systemic inflammation, as well as gastrointestinal  and neurological symptoms.

The most notable symptoms among the findings were psychological distress such as “trauma and anxiety,” along with a reduction in “functional exercise capacity.” It is still unclear, however, if these symptoms are a result of preexisting physical and psychological  conditions or the impact of the COVID-19 pandemic in general. Nonetheless, the most severe symptoms from MIS-C were resolved by 6 months. Future research regarding outcomes of MIS-C beyond the 6 month mark will be necessary to further understand the long-term impact of this syndrome. 

Gastrointestinal issues persist in many, months after COVID-19 infection

May 26, 2021

Diarrhea and other gastrointestinal (GI) issues are known to be non-respiratory COVID-19 symptoms during an active infection. However, a team of researchers in Italy were curious whether their patients were continuing to experience these symptoms after their period of infection ended. Their study utilized a self-report survey, which was emailed to patients that had been treated for COVID-19 in March and May 2020 at Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico in Milan. Hospital workers who had tested negative for COVID served as controls. 164 COVID-19 survivors and 183 uninfected controls submitted their survey responses. The results indicated that loose stool was ranked as the most commonly experienced GI issue and it appeared twice as frequently in the responses of survivors when compared to controls.

Covid-19 and the development of autoimmune thyroid disease 

May 25, 2021

A recent literature review illuminated the association between both relapsing and newly diagnosed thyroid disease, to include Grave’s disease, following a COVID-19 infection. Graves’ disease is an autoimmune disease where the immune system attacks the thyroid, causing an overproduction of hormones (hyperthyroidism). 

Reports were usually documented one month after a COVID-19 infection. Cases showed that a COVID-19 infection may aggravate autoimmune thyroid disease through the development of a cytokine storm. Read more about cytokine storms, autoimmune disease, and COVID-19 infection in our article that dives into the juxtaposition of both the Sars-CoV-2 virus and autoimmunity.

Graphic explaining role of hyperferritinemia and cytokine storms in autoimmune disease and covid-19

Data accumulated in the literature review indicates that the thyroid hormone plays a role in protecting the lungs from injury, to include injury from COVID-19. Only a small fraction of the literature covers patients developing autoimmune hypothyroidism, and it has yet to be determined if these cases preceded infection or were triggered by it. The literature is also unclear whether COVID-19 definitively increases the risk of developing autoimmune hypothyroidism. That being said, the “known association between COVID-19, the development of cytokine release syndrome, and the triggering of autoimmunity, supports the hypothesis of COVID-19 triggering autoimmune thyroid disease, including autoimmune hypothyroidism.

There has been an influx of literature covering patients with Graves’ disease (one type of hyperthyroidism), including how these patients may experience enhanced symptoms of both Graves’ disease and COVID-19. Additionally, around 15% of patients experiencing mild to moderate cases of COVID-19 have experienced thyroid dysfunction.

Researchers from this study are calling out for thyroid function to be routinely assessed when caring for patients with a COVID-19 infection. Further research must be conducted to clarify whether a SARS-CoV-2 infection targeting the thyroid is influenced by patient co-morbidities, genetic factors, or disease history. 

Research developments on the World’s Prominent Covid-19 vaccines

May 19, 2021

Researchers around the world are creating and testing close to 100 vaccines in an effort to combat the novel coronavirus. The following Vaccine Comparison Chart provides a breakdown of leading vaccines which have shown promise through pre-clinical data, completed Phase 1/2/3 clinical trials, and have been authorized for emergency use.

Preclinical data is collected when testing a vaccine on cells and animals. If an immune response is detected, the study moves forward as a Phase 1 safety trial by testing the safety of the vaccine on a select number of people (typically around 20-80 people).

If the dosage is deemed safe and effective, the trial progresses to a Phase 2 expanded trial, in which hundreds of people receive the vaccine. At this stage, participants are split into groups to observe the vaccine’s efficacy and safety across a spectrum of ages.

A Phase 3 efficacy trial tests for vaccine efficacy against volunteers who receive a placebo. Thousands of participants are included in the trial, and an efficacy rate is determined for the vaccine against a virus.

Due to the nature of the coronavirus, some vaccine trials underwent combined phases (e.g. Phase 1/2) in order to accelerate development.

CDC announces recommendation of Pfizer Vaccine for 12-15 Year olds

May 13, 2021

There have been over 1.5 million cases of COVID-19 amongst children, with more hospital cases than the annual flu in an average year (1). Most children with COVID-19 have mild or no symptoms, however some children can develop multisystem inflammatory syndrome (MIS-C) after a COVID-19 infection and require hospitalization.

Yesterday, the CDC announced their recommendation to use the Pfizer vaccine in children ages 12-15 (2). While 12-15 year olds account for roughly 5% of the US population, their ability to transmit the virus is thought to increase with age, and inoculating this age group against COVD-19 will increase immunity as a whole. Reports from clinical trials submitted to the FDA and reviewed by the CDC’s Advisory Committee on Immunization Practices verify the dose used for adults is safe and effective in this younger age group. This means many of the unused vaccine doses can be redirected to inoculate children.

FDA extends Pfizer Vaccine EUA to children 12-15 years old

May 11, 2021

On Monday, the FDA granted Pfizer emergency use authorization of their vaccine in children ages 12-15 years old. This is the first vaccine authorized for persons 12+ years old. 

In a Phase 3 clinical trial, 2,260 participants ages 12-15 were given a placebo or two doses of the vaccine, 21-days apart. Eighteen cases of symptomatic COVID-19 were recorded in the placebo group, but none were recorded amongst children who received the vaccine. The trial showed a “vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses.” The vaccine was also “well tolerated,” and side effects were comparable to those seen in clinical trials amongst young adults, ranging from 16-25 years of age.

Pfizer is continuing to collect data on asymptomatic cases from clinical trial participants, and participants will be monitored “for long-term protection and safety for an additional two years after their second dose.” 

While the risk of children catching COVID-19 is low, the risk of developing multi-inflammatory syndrome (MIS-C) is higher than the potential risk of experiencing symptoms from the vaccine. Additionally, being vaccinated against COVID-19 mitigates the development and spread of variants

The CDC’s Advisory Committee on Immunization Practices will be convening shortly to review the clinical data and make recommendations on the vaccine’s use in adolescents. After their endorsement, immunizations can begin. The data from Pfizer’s trial has also been submitted to the European Medicines Agency and other regulators to extend the EUA.

The CureVac Vaccine

May 10, 2021

The German company, CureVac, is in the process of finalizing an RNA vaccine against COVID-19 with the culmination of its Phase 3 trial (1). The trial included 40,000 participants across Latin America and Europe. If the data shows the vaccine to be safe and effective, this may be the third RNA vaccine authorized for emergency use. Moreover, the CureVac vaccine is refrigerator-stable, making it more transportable than the Pfizer and Moderna vaccines. This gives CureVac an unique opportunity to supply vaccines to more remote locations, as well as locations that have yet to be supplied with ample doses, like lower and middle-income countries.

Data from the trial is expected by mid-May with promising results against variants such as the B.1.351 variant.

Pfizer submits application for FDA approval of COVID-19 vaccine

May 7, 2021

This morning, Pfizer-BioNTech submitted a Biologics License Application (BLA) to the FDA for approval of their COVID-19 vaccine. Currently, the Pfizer vaccine has been granted an EUA due to the state of the pandemic, which allowed them to provide safety and efficacy data from two months of trials versus the standard six months. “Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review” (1).  

The Pfizer vaccine has been readily available since mid-December 2020. Alongside their Phase 3 clinical trial, data regarding the vaccine’s safety and efficacy has been collected from the 170+ million doses administered in the U.S.

Pfizer is currently the only vaccine manufacturer authorized for people 16+ years of age. The approval would cover the same ages, even though Pfizer is currently applying for an EUA extending use of their vaccine to children 12-15 years of age. They expect to apply for final approval after acquiring six months worth of data after the second dose is administered.

Yale to begin study on Covid long-haulers

May 7, 2021

Yale Medicine is launching a collaborative study on Covid long-haulers and the Covid vaccine

Yale will be recruiting participants with long-term symptoms following a COVID-19 infection, who have not been vaccinated yet. Blood and saliva samples will be collected prior and post vaccination to compare and correlate immune responses in long-haulers and symptom changes (if any). Participants will evaluate any changes to their post-Covid conditions after being vaccinated. Researchers will also study the mechanisms behind how the vaccine resolves post-Covid conditions – whether the vaccine is stopping a harmful immune response, resetting the immune system, or is fighting against residual virus.

Reportedly, 30-40% of long haulers who receive the vaccine experience improvement of symptoms like brain fog, gastrointestinal issues, and shortness of breath. Autoimmune reactions are one possible reason why COVID-19 patients continue to experience symptoms 4+ weeks after infection, and those with compromised immune systems are thought to be more likely to experience long Covid.

Rare Skin Reactions Following COVID-19 Vaccines Are Being Studied

May 6, 2021

Recent findings from the COVID-19 Dermatology Registry, run by the American Academy of Dermatology (AAD) and the International League of Dermatologic Societies, helped shed some light on the skin reactions reported after Moderna and Pfizer COVID-19 vaccinations in some individuals. In this study, 414 cutaneous reactions were reviewed, ranging from minor injection-site inflammation to an episode of shingles.

This research is unique because it delves into a whole range of reactions that had not been reported in vaccine clinical trials. Detailed information was collected from registry participants, including which type of vaccine was received and when and the morphology, timing, duration, and treatment of the skin reactions. The most common morphologies seen in this study were “delayed large local reactions, local injection site reactions, urticaria, and morbilliform eruptions.”

The skin reaction seen most often following the Moderna vaccine was urticaria, also known as hives. Researchers have found that in 50% of patients who experience chronic idiopathic urticaria, the immune system behaves erratically and attacks the body’s normal tissues, causing hives. Could this be the same mechanism happening in these rare cases following the COVID-19 vaccine? What can these post-vaccine reactions tell us about the field of autoimmunity as a whole? While we wait for scientists to uncover these answers, the good news is that none of the patients who had skin reactions reported severe adverse events, and less than half did not experience a recurrence with their second dose.

FDA may expand EUA of Pfizer vaccine to include 12-15 year olds

May 4, 2021

In March, Pfizer released the results of a clinical trial announcing that their COVID-19 vaccine displayed 100% efficacy in adolescents ages 12-15 years of age. The FDA has been reviewing the results of this Phase 3 trial, and an amendment to the current Emergency Use Authorization (EUA) of Pfizer’s vaccine is said to be determined next week. While 22% of the U.S. population is composed of children under 18 years of age, Pfizer is the only vaccine manufacturer in the U.S. currently authorized for ages 16-18. If the EUA is amended, Pfizer will be the first vaccine manufacturer authorized for use in people ages 12-18.

The COVID-19 Vaccine and Immune Disorders

April 27, 2021

The NIH will be conducting a clinical trial testing COVID-19 vaccine responses in people with immune deficiencies. These will include primary and secondary immune system disorders. In addition to learning how this population responds to the COVID-19 vaccine, this study aims to fill the gap regarding the clinical presentation of COVID-19 in those with immune deficiencies, “especially those who have inborn conditions involving deficits or dysregulations in antibody or cell-based immune responses to infections.”

Because those with immune disorders were excluded from the COVID-19 vaccine clinical trials prior to emergency authorization, this study will “characterize the features and adequacy of immune responses to COVID-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes.” The study will include 500 participants, 400 of which have primary or secondary immune system disorders and are 16 years of age or older. If participants get vaccinated during the study, blood samples will be taken before and after vaccination and studied for “short-term immunological effects of immunization.”

Participants may voluntarily provide blood samples at different intervals following their last dose of the vaccine. Researchers will then assess the T-cell response and vaccine-induced antibody production in those with immune disorders compared to those without immune system disorders.

For more information regarding the study and enrollment, visit clinicaltrials.gov and use the search code NCT04852276.

Johnson & Johnson's COVID-19 vaccine has been resumed

April 26, 2021

This past Friday, the CDC lifted the pause on Johnson & Johnson’s COVID-19 vaccine usage. During this pause, which was announced April 13, the CDC confirmed an additional 9 cases of women developing thrombosis with thrombocytopenia syndrome (TTS) – blood clots with low platelet count – after receiving the J&J vaccine. The pause was initiated after 6 cases were presumed to be linked to the J&J vaccine. 13 of the 15 women were between the ages of 18-49.

Before getting the vaccine, recipients are encouraged to review the Janssen COVID-19 Vaccine fact sheet for recipients and caregivers, which includes side effects and risk information. That being said, the FDA and CDC state this vaccine is safe and effective in preventing COVID-19, and that the potential risks are outweighed by the benefits of receiving the COVID-19 vaccine. Furthermore, “at this time, the available data suggests that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk” (1). 

The CDC and FDA continue to encourage those who have received the vaccine and experienced adverse effects to submit a report to the Vaccine Adverse Event Reporting System

6 patients with autoimmune inflammatory disorders develop shingles after mrna vaccine

April 20, 2021

The Tel Aviv Medical Center and Carmel Medical Center are conducting a study monitoring adverse events in patients with autoimmune inflammatory disorders. This includes patients with rheumatoid arthritis, vasculitis, myositis, Sjogren’s and spondyloarthritis for 6-weeks post COVID-19 vaccination. Of 491 patients with autoimmune inflammatory rheumatic diseases, six have been diagnosed with herpes zoster (shingles) for the first time after receiving an mRNA vaccine. Five cases occurred after receiving the first dose, and one after the second dose. Five of the six patients had not been vaccinated for shingles prior to receiving the COVID-19 vaccine. 

As of now, there have not been reports of shingles in clinical trials. That being said, there is limited data regarding the safety of COVID-19 vaccines in those with autoimmune and rheumatic disease, as immunocompromised participants were not included in clinical trials.

The authors of this study make it clear that these six cases do not determine a causal link, especially since other factors were likely to impact these outcomes. For example, the risk of shingles doubles in patients with rheumatoid arthritis. Risk also increases when taking high doses of prednisone, and doubles when being treated with certain anti-rheumatic drugs (such as tofacitinib, e.g. Xeljanz). “Potential mechanisms that might explain the pathogenetic link between mRNA-COVID-19 vaccination and herpes zoster reactivation are related to stimulation of innate immunity through toll-like receptors by mRNA-based vaccines” (1). 

Five patients received antiviral treatments which resolved their shingles; the five patients who had only received one dose before the onset of their symptoms received the second dose and did not experience other adverse effects.

Herpes zoster reactivation after vaccination has been studied with other diseases such as Hepatitis A and rabies (2). According to the authors of this study, these are the first reported cases of shingles reactivation after a COVID-19 vaccine. There has also been an uptick of shingles cases reported globally in the context of COVID-19 infection (1).

Further investigation and reporting of adverse events is crucial to understanding the prevalence of herpes zoster reactivation after COVID-19 infection. This study started in December 2020 and is ongoing.

Americans 16+ are eligible for COVID-19 vaccine

April 20, 2021

As of yesterday, Monday, April 19, all American ages 16+ are eligible to get the COVID-19 vaccine. According to the CDC’s COVID Data Tracker, over 132 million Americans have received one dose of the vaccine, and over 85 million have been fully vaccinated against the novel coronavirus. This 85 million figure represents 64.9% of Americans 65+ years of age. 

As of now, the Johnson & Johnson vaccine has been paused in all 50 states, with facilities distributing Moderna and Pfizer vaccines. During a press briefing this past Sunday, Dr. Fauci stated he expects a decision to be made by this upcoming Friday whether or not to continue the pause of Johnson & Johnson’s vaccine (1). This will be decided by the FDA. 

NIH funds clinical trial for new COVID-19 antibody therapy

April 19, 2021

The NIH is funding a Phase 2 clinical trial testing a monoclonal antibody for COVID-19 patients hospitalized with respiratory disease and low blood oxygen count. The FDA has previously issued emergency use authorization for COVID-19 antibody therapies by Eli Lilly and Regeneron

This new IC14 monoclonal antibody “binds to a human protein, CD14, that is found on the surface of immune cells circulating in the blood and airway fluid… CD14 helps immune cells recognize pathogens and injured or dying cells, alerting the immune system to danger and prompting it to respond” (1). 

CD14 may be one factor that induces a “cytokine storm.” Cytokines play an influential role in the immune response to a viral infection. Moreover, a cytokine storm provokes a severe immune reaction, and in COVID-19 patients, often causes “dangerous levels” of inflammation and tissue damage in the lungs, which can result in acute respiratory distress syndrome and failure (1). Blocking CD14 proteins using the IC14 antibody may decrease the immune system’s hyper response to a COVID-19 infection. To read more about cytokines and the overlap between a COVID-19 infection and autoimmune disease, check out our featured article. 

Researchers hope to determine whether the IC14 antibody decreases in-hospital recovery time for patients with COVID-19-induced respiratory disease, as well as its severity.

U.K. expands clinical trial for mixing COVID-19 vaccines between four manufacturers

April 16, 2021

The University of Oxford has expanded their clinical trial investigating the safety and efficacy of interchanging COVID-19 vaccines (1). While interchanging doses will primarily reduce vaccine shortages and allow for more rapid vaccinations, countries such as Germany have already updated vaccine recommendations for mixing vaccines. Those under 60 years of age who have received the AstraZeneca vaccine are recommended to get Pfizer or Moderna for their second dose. This is in response to several dozen blood clotting cases amongst German citizens under 60 years old (2). 

The U.K. clinical trial began in February, interchanging vaccine doses between AstraZeneca and Pfizer. As of this past Wednesday, it will expand to include the Novavax and Moderna vaccines. Participants will include women and men 50 years of age and older, who have already received one dose of the COVID-19 vaccine.

Investigators will observe any adverse reactions and compare efficacy rates between mixing doses versus using one manufacturer to complete the vaccine schedule.

NIH to study allergic reactions to mRNA vaccines

April 14, 2021

The NIH is sponsoring a clinical trial focusing on the risk of allergic reactions to Moderna and Pfizer’s mRNA vaccines. The COVID-19 mRNA vaccines are the first mRNA vaccines to be authorized by the FDA. 

This clinical trial will “determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.” A systemic allergic reaction is qualified as a vaccine reaction in one or more regions of the body outside of the injection site. A mast cell disorder occurs when mast cells (white blood cells) are overly active or behaving abnormally, causing allergic reactions. Investigators will also “examine the biological mechanism behind the reactions and whether a genetic pattern or other factors can predict who is at most risk.”

Investigators aim to enroll 3,400 adults, aged 18-69, across 35 allergy-research centers. Approximately 60% of participants will need to have a history of “severe allergic reactions or a diagnosis of a mast cell disorder.” Allergic reactions can be related to food, insect stings, or an allergen immunotherapy that requires treatment with an epi-pen (epinephrine). Participants may also enroll if they have a history of immediate allergic reactions to a vaccine or one or more drugs. This study plans to enroll more women than men, as women account for the majority of severe allergic reactions to the COVID-19 vaccine. 

The clinical trial is currently enrolling participants.

Adenovirus vaccines shown to have hematological side effect concerns

April 13, 2021

As of yesterday, 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered throughout the United States. As of today, the CDC and FDA announced that they are reviewing six reported cases of a “rare & severe type of blood clot in individuals after receiving the vaccine” and are recommending a “pause” in the use of the single-dose Johnson & Johnson COVID-19 vaccine until a more thorough investigation can be conducted. The CDC will convene a meeting of the Advisory Committee on immunization practices (ACIP) tomorrow, Wednesday, April 14th, to further review these cases and assess their potential significance, and this analysis will also be reviewed by the FDA.

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This is not the first time we’re hearing about rare blood clots forming following COVID-19 vaccination, as reports from the Oxford-AstraZeneca vaccine have shown similar concerns. As of this week in Europe, 34 million people have received their first dose of the AstraZeneca vaccine and there are at least 222 suspected cases of dangerous blood clots and low platelet counts. On April 7, the UK Medicines and Healthcare Products Regulatory Agency stated that it had been “investigating at least 79 cases of strokes and clotting events tied to the vaccine, at least 18 of them fatal.”

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The side effects being observed following vaccination are a combination of cerebral venous sinus thrombosis (blood clotting in the sinus that drains blood from the brain) and thrombocytopenia (low levels of blood platelets that stop bleeding). Researchers have concluded that the side effects resemble an autoimmune disorder called heparin-induced thrombocytopenia (HIT) and significantly all six cases occurred among women between the ages of 18 and 48

Some experts initially theorized that vaccine-induced immune thrombotic thrombocytopenia (VITT) was occurring as a result of the antibodies created to fight the virus’ spike protein cross-reacting with Platelet Factor 4 (PF4). PF4 is involved in wound repair and inflammatory responses. If this were the case, it would be a safety concern for all COVID-19 vaccines. However, there is currently no evidence that messenger RNA-based vaccines (such as Pfizer and Moderna), which have been received by tens of millions of people, are causing similar blood clotting and low platelet issues

Regeneron antibody cocktail protects against COVID-19

April 12, 2021

Regeneron published a news release this morning stating their REGEN-COV antibody drug demonstrated high levels of protection against COVID-19 in a Phase 3 clinical trial. Those eligible to enroll in the study were not infected with COVID-19, did not show symptoms, did not have SARS-Cov-2 antibodies, and were living with someone who tested positive for COVID-19 within four days of enrolling. Of 1,505 volunteers, the antibody drug demonstrated 72% protection against symptomatic infection in the first week, and 93% in weeks thereafter. Those who received the antibody drug were also 81% less likely to get sick with COVID compared to those who received the placebo. On average, those experiencing symptoms “resolved their symptoms in 1 week, compared to 3 weeks with placebo. Infected individuals also cleared the virus faster with REGEN-COV.”

The REGEN-COV cocktail combines two drugs which mimic the antibodies created by the immune system when exposed to the virus. These monoclonal antibodies block the COVID-19 infection and neutralize the virus by diminishing its ability to “escape treatment.”

Even though experts are hoping Regeneron’s antibody cocktail will be used as a preventative measure for those who are immunocompromised, this population was not included in the clinical trial. That being said, this can be used as another option for high-risk COVID patients, those who experienced an adverse reaction after receiving their first dose of the COVID-19 vaccine, or those currently on immunosuppressive therapies (whose immune system may not respond well to the vaccine).

Regeneron plans to seek emergency authorization by the F.D.A to use the antibody cocktail as a preventative measure against the coronavirus. They are also seeking approval to administer the cocktail via injection versus intravenous infusion. 

Risk of contracting SARS-CoV-2 from surfaces is less than 1 in 10,000

April 9, 2021

The CDC has updated their SARS-CoV-2 and Surface Transmission guidelines, stating that the chance of contracting the coronavirus from surfaces is less than 1 in 10,000.

This comes after mounting evidence that the virus primarily spreads through airborne droplets, which can remain in the air for minutes to hours. “The length of time [the] virus remains suspended and is infectious depends on numerous factors, including viral load in respiratory droplets or in small particles, disturbance of air and surfaces, ventilation, temperature, and humidity.”

The infection-rate within the community, the amount of viral shedding by those who are infected, and the interaction between virus particles and the environment, are some factors that can increase the risk of viral transmission. This reinforces the necessity of wearing masks, especially in closed spaces, to reduce the spread of the virus both in the air and on surfaces.

The CDC also states that “in most situations, cleaning surfaces using soap or detergent, and not disinfecting, is enough to reduce risk.” The envelope (the outer layer of proteins and lipids) housing the genetic material of the SARS-CoV-2 virus is easily altered and can “degrade quickly upon contact with surfactants contained in cleaning agents and under environmental conditions.” Cleaning agents alone can remove the virus from surfaces. However, to “substantially inactivate” the virus on surfaces, it must be treated with a disinfectant product. Increasing ventilation is one way of reducing the risk of airborne transmission. 

Vaccine and Immune Response Efficacy Against SARS-CoV-2 variants 

April 6, 2021

The NIH published a news release on a recent NIAID study evaluating blood samples of COVID-19 patients to determine the efficacy of vaccines and the immune system’s ability to recognize and combat new SARS-CoV-2 variants. 

The emergence of new SARS-CoV-2 variants have raised concerns across the scientific community in regard to variant severity. COVID-19 variants are mutations in the SARS-CoV-2 virus, which ultimately make the virus less recognizable to antibodies and have the possibility to impact immune response and vaccine efficacy in future COVID-19 infections.

The study focused on CD8+ T cells; these are critical in establishing adaptive immunity against the virus by recognizing and killing viral proteins. The NIAID’s findings determined that the CD8+ T cells “are largely not affected by the mutations found in these variants, and should offer protection against emerging variants.” Prime immunity through vaccination and antibody creation require strong CD8+ T cell responses to recognize and protect against evolving SARS-CoV-2 strains. Investigators noted that more research is needed in understanding T cell defense against current and variant strains of SARS-CoV-2. That being said, this study provides a greater understanding of the SARS-CoV-2 virus, which is critical in developing vaccines with high efficacy rates against variants. 

Neon Turquoise colorized scanning electron micrograph of a T cell
Colorized scanning electron micrograph of a T cell. Credit: NIAID, NIH

 

Vaccine Eligibility by State 

April 5, 2021

As eligibility requirements expand to include more occupations and health statuses, those living with autoimmune disease will have access to the COVID-19 vaccine. Many states have already instituted universal eligibility, with others set to expand eligibility requirements in April. Check out this vaccine eligibility tracker updated regularly by the New York Times to view vaccine eligibility by state.

Changing Vaccine Manufacturers between Doses

April 2, 2021

The UK has established a vaccine protocol allowing patients to receive their first and second vaccine doses from different manufacturers. This is permissible if a second dose of the vaccine is unavailable or the manufacturer of the first dose is unknown. Currently, the only vaccines authorized for emergency use in the UK are by Pfizer, Moderna, and AstraZeneca.

The government protocol adds that “this option is preferred if the individual is likely to be at immediate high risk or is considered unlikely to attend again” (1). It is not required that patients receive a second dose if it means using a vaccine from a different manufacturer than the first dose. 

It is important to note that the Pfizer and Moderna vaccines use lipid nanoparticles (non-water-soluble liquids) to deliver the mRNA, whereas AstraZeneca uses an adenovirus to deliver a coronavirus spike protein. The double-stranded DNA is a “cousin” of mRNA, and the vehicles for delivery are unique. 

Trials are currently underway studying the safety and efficacy of mixing vaccines from different manufacturers. 

The CDC has made it clear that patients in the US should receive doses from the same vaccine manufacturer. The only time vaccines should be mixed is after receiving an mRNA vaccine and using a single-dose of Johnson & Johnson’s (J&J) vaccine as the second dose. The protocol for changing vaccine manufacturers between doses has not been tested and should be limited to “exceptional situations;” for example, where the patient experienced an adverse reaction after receiving the first mRNA vaccine (2). The J&J vaccine may be administered 28+ days after the first mRNA COVID-19 vaccine. Patients are encouraged to view the CDC’s list of Contraindications and Precautions beforehand if they’ve experienced an adverse reaction to the mRNA COVID-19 vaccine and are hoping to get the J&J vaccine. To learn more about getting vaccinated when you have an autoimmune disease and why contraindications can occur, check out our article. 

Because the vaccines deliver genetic material through different methods, use different fillers, and are designed to induce an immune response over a two-step process using the same delivery method, it is not yet possible to say whether interchanging vaccines will offer the same rate of efficacy or safety demonstrated in clinical trials.

Pfizer Confirms High Efficacy and Safety 6 months following second vaccine

April 1, 2021

Today, Pfizer released a statement confirming their vaccine has exhibited “high efficacy and no serious safety concerns through up to six months following [the] second dose.” 

The Pfizer vaccine has demonstrated a 91.3% efficacy rate against COVID-19 from seven days through up to six months after delivery of the second dose. The vaccine was 100% effective against severe COVID-19. The vaccine also demonstrated 100% efficacy against the B1.351 variant. This data provides “the first clinical results that a vaccine can effectively protect against currently circulating variants.” 

“Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose.” Over the six month period, no serious safety concerns were observed after receiving the second dose.

It should be noted that “immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine,” according to the U.S. FDA Emergency Use Authorization Prescribing Information. Data on Pfizer’s COVID-19 Vaccine administered to immunocompromised patients and people with autoimmune disease are incomplete, and are insufficient in informing risks for this population group. That being said, the FDA has said that those living with autoimmune disease may receive the COVID-19 vaccine. Patients should speak with their doctors regarding their healthcare plan before receiving the vaccine.

Pfizer vaccine demonstrates 100% efficacy in 12-15 year olds

March 31, 2021

Today, Pfizer-BioNTech published a press release announcing the results of their Phase 3 clinical trial in adolescents. The trial enrolled 2,260 participants in the United States, aged 12 to 15, with 1,129 participants in the placebo group and 1,131 participants in the vaccinated group. In the trial, 18 cases of COVID-19 infections were observed in the placebo group. Comparatively, none of the participants from the vaccinated group contracted COVID-19.

The vaccine is currently only authorized for people aged 16 and older in the United States, so this data may play a role in amending the vaccine’s emergency use authorization. It is important to note that while this data is still under review, this is promising news. The next steps include requesting expansion of the Emergency Use Authorization (EUA) by the FDA in the United States.

UK begins first COVID-19 Human Challenge Trial

March 30, 2021

On February 17, 2021, the UK approved the world’s first COVID-19 human challenge trial. The trial includes infecting up to 90 healthy participants with the virus and tracking just how it affects the human body, in an effort to aid the development of new vaccines and treatments for the novel coronavirus. This trial differs from typical clinical trials in that participants are not receiving an experimental vaccine but rather the pathogen itself. 

As of March 25, three volunteers who had been exposed to SARS-CoV-2 via nasal droplets finished quarantining at the Royal Free Hospital in London, and will continue to be monitored by a clinical team (1). These three patients did not experience unexpected issues or complications, and “are in good health(1). While further details of the study – including symptoms – will be kept confidential, researchers are recruiting more healthy volunteers between the ages of 18-30 to “establish the lowest possible dose of virus needed to cause viral replication in the nose and throat” (1). This study will also assist in understanding the progression of the virus once inside the body, natural immune response, and transmission.

COVID-19 versus seasonal influenza outcomes in autoimmune disease patients 

March 29, 2021

A recent multi-national study evaluated 30-day outcomes in hospitalized COVID-19 patients living with autoimmune disease (AD). Data was aggregated from centers including Columbia University Irving Medical Center and Information System for Research in Primary Care-Hospitalisation Linked Data in Spain. 133,589 patients diagnosed and 48,428 hospitalized with COVID-19 and living with autoimmune disease were included in the study.  

This international study used inpatient electronic health records (EHR) to collect and compare data of autoimmune disease patients infected with COVID-19 (between January and June 2020) to those infected with seasonal influenza (between 2017-2018). The most prevalent autoimmune diseases reported in the study were psoriasis, rheumatoid arthritis, and vasculitis. 

Data showed that roughly 30% of patients infected with COVID-19 were hospitalized while roughly 17% of influenza patients were hospitalized. On average, 30% of COVID-19 patients developed acute respiratory distress syndrome (ARDS) compared to 22% of seasonal influenza patients. Overall, hospitalized patients with COVID-19 and living with autoimmune disease experienced higher mortality rates and intensive care requirements compared to seasonal influenza patients (1).

This study highlights the prevalence of respiratory complications in COVID-19 patients versus influenza patients. It is clear that patients with autoimmune disease are at risk of more severe outcomes, complications and higher mortality rates after COVID-19 infection compared to influenza. This data is especially significant to confute assertions that the severity of COVID-19 parallels seasonal influenza; those who are immunocompromised should continue to take proper prevention measures to decrease risk of infection. 

Astrazeneca's COVID-19 vaccine demonstrates 76% efficacy

March 26, 2021

AstraZeneca has released an updated statement revealing their vaccine demonstrates 76% efficacy against symptomatic COVID-19 and 100% efficacy against severe COVID-19 and hospitalization. They previously stated a 79% efficacy based on data through February 17, 2021. Experts credit this discrepancy to a rounding error (1).

These results have been submitted for review to the Data Safety Monitoring Board, and will be the “basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks” (2).

Some immunosuppressants dampen vaccine’s ability to create immune response

March 24, 2021

Last week, researchers at Johns Hopkins released the results of a cohort study measuring the antibody production of 436 solid organ transplant recipients following their first dose of an mRNA vaccine. Immunocompromised patients were excluded from mRNA clinical trials. The results of this study – although they’re exclusive to solid organ transplant recipients – can shed light on antibody production for those on immunosuppressant therapies. 

Participants collected blood samples at home with a TAII blood collection device or standard venipuncture in a medical office, which was then tested for antibodies against the SARS-CoV-2 spike protein. Tests were conducted 14-21 days after receiving the first dose of the Moderna or Pfizer vaccine. 

The median time since transplant was 6.2 years, and participants reported taking tacrolimus, corticosteroids, mycophenolate, azathioprine, sirolimus and everolimus as part of their maintenance regimen. Mycophenolate and Azathioprine have antimetabolite agents and can be used to treat autoimmune diseases such as lupus, rheumatoid arthritis, and IBD (1, 2). 

Antibodies were detectable in 75 of 436 participants following the first dose of the vaccine. This is approximately 17% of participants. Transplant recipients on antimetabolite therapies like Mycophenolate and Azathioprine were around 5x less likely to develop an antibody response than those not receiving such immunosuppression therapy. 

Overall, younger participants who were not under antimetabolite maintenance immunosuppression and received the Moderna vaccine were more likely to develop antibodies. Those who received the Moderna vaccine were more likely to develop antibodies than those who received the Pfizer vaccine (60% versus 31%). While clinical trials observed a 100% antibody response for both the Moderna and Pfizer vaccines, this vast discrepancy shows the impact of immunosuppressants on the vaccine’s ability to create a robust immune response. 

Vaccine recipients taking immunosuppressants should be made aware that they may still be high-risk to COVID-19. Dr. Segev, associate vice chair of surgery at Johns Hopkins University School of Medicine and Bloomberg School of Public Health, as well as a co-author of the study, is calling for the CDC to update their guidelines to reflect the ongoing risk immunosuppressed people, as well as certain autoimmune patients, may have to COVID-19 even after vaccination (3). This study is ongoing and researchers are in the process of collecting data on antibody production after receiving a second dose of the vaccine, as well as T-cell and B-cell responses when antibodies are scarce.

3-D rendering of B cell antibodies attacking COVID-19 cellGraphic rendition of yellow B cells (antibodies) attacking a COVID-19 cell

 

NIH Releases Statement Regarding AstraZeneca Vaccine

March 23, 2021

The National Institute of Allergy and Infectious Diseases (NIAID) published a news release today regarding AstraZeneca’s COVID-19 vaccine clinical trial, after being notified by the Data and Safety Monitoring Board that outdated information “may have provided an incomplete view of the efficacy data” (1). Which information is outdated has not been specifically disclosed. This statement was released one day after the NIH published a media advisory that the investigational AstraZeneca vaccine prevents COVID-19

The placebo-controlled trial included 32,449 adult participants across the US, Chile, and Peru, with approximately 20,000 receiving the vaccine versus 10,000 receiving a placebo. The vaccine was administered as two doses, four weeks apart, and demonstrated 79% efficacy in preventing symptomatic COVID-19. The vaccine showed 100% efficacy in preventing severe symptoms. 

Symptomatic COVID-19 was defined as having a SARS-CoV-2 infection and at least one respiratory symptom, or at least two of the following: loss of taste and/or smell, fever, muscle pain, fatigue, vomiting and/or diarrhea, and cough. Severe symptoms included a SARS-CoV-2 infection and at least one of the following: signs of severe systemic illness, respiratory failure, shock, significant acute renal, hepatic or neurologic dysfunction, ICU admission, and death. 

Similar to Johnson & Johnson’s COVID-19 vaccine, the AstraZeneca vaccine uses an adenovirus to deliver incomplete SARS-CoV-2 genetic material to the body; it does not carry a live SARS-CoV-2 virus. 

AstraZeneca published an update this morning following NIAID’s follow-up statement, stating they will “immediately engage” with the Data and Safety Monitoring Board and share the most up-to-date efficacy data within the next 48 hours (2). Any updated information provided by AstraZeneca will be reviewed by independent advisory committees to ensure accuracy before the FDA and CDC start the authorization process for the use of AstraZeneca’s vaccine in the U.S. It is currently available for use in over 70 countries (3).

Some states are lifting vaccine eligibility requirements

March 19, 2021

The following states will be lifting eligibility requirements for residents to be vaccinated: 

 

March 2021:

Utah (week of March 21, 2021)

Ohio (starting March 29, 2021)

 

April 2021:

Connecticut

Illinois

Kentucky

Maryland 

Missouri 

Rhode Island

 

Alaska and Mississippi have already instituted universal eligibility. 

As of today, March 19, 39.6% of adults 65 years and older have been fully vaccinated in the U.S. View more stats and daily updates regarding vaccine distribution in the U.S. with this COVID Data Tracker by the CDC. You can also check out this resource by The Wall Street Journal for a state-by-state guide on vaccine eligibility requirements.

Some long-haulers find relief after getting the COVID-19 vaccine

March 18, 2021

Long-haulers are sharing stories of symptom relief after receiving the COVID-19 vaccine. While anecdotal as of now, patients from across the country are reporting that their symptoms have improved or even resolved after getting their first dose of the COVID-19 vaccine. Survivor Corps, one of the largest patient communities advocating for COVID-19 long haulers, recently released a poll on Facebook asking members how they felt post-vaccination. As of March 18, 2021, 40% of participants said that their long-COVID symptoms improved after being vaccinated (1). 

University of California San Francisco is currently conducting a clinical trial studying the long-term impact of a COVID-19 infection. This observational study is investigating the “clinical consequences of a SARS-CoV-2 infection” to include immune activation, changes in immunologic function, and the development of medical conditions (2). The NIH also announced February 23 that they will be allocating more than $1.1 billion over the next four years to study the impact long-COVID.

Typically, long-haulers experience fatigue, shortness of breath, body aches, inability to concentrate, headaches, loss of taste and/or smell, as well as other symptoms continuing 6+ weeks after a COVID-19 infection (3). Experts are unsure as to why or how vaccination is leading to symptom relief for some long-haulers. Long COVID has been likened to Lyme disease, and the production of autoantibodies leading to autoimmune disease has also been discussed as a theory behind some long-COVID symptoms. Some hypothesize that the immune system may be getting a “boost” from the vaccine to resolve persistent symptoms (1, 4). 

You can find more news on long-haulers through the Survivor Corps website.

Updated CDC Guidelines on Vaccinations

March 10, 2021

The CDC updated their COVID-19 guidelines on March 8, 2021 for people who are vaccinated. Those who have been fully vaccinated are safe to: 

  • Gather indoors with other fully vaccinated people without masks
  • Gather indoors with unvaccinated people from one other household without masks
  • Do not need to quarantine after exposure to someone with COVID-19 unless symptoms are present

Of course, those who are immunocompromised or have an increased risk of severe COVID-19 symptoms should continue to take extra precaution.

It is still unclear how long immunity lasts after being vaccinated, how effective these vaccines are against certain variants, and just how much vaccines mitigate the spread of COVID-19 from person-to-person contact. Bearing these unknowns in mind, the CDC cautions everyone to continue wearing a mask in public places, maintaining physical distancing, avoiding crowded spaces, as well as getting tested if COVID-19 symptoms occur, even if they are fully vaccinated (1).

Type 1 Diabetes patients become eligible for covid-19 vaccine in 12+ states

March 5, 2021

The Colorado Department of Health along with 11 other states just raised vaccination eligibility requirements for type 1 diabetes patients as a “high risk” group (2, 3). In Colorado, anyone between the ages of 16-64 who have T1 diabetes and one other high risk condition will be eligible to get the coronavirus vaccine as early as today, March 5. They will be included in the 1B.3 vaccine group (1). This comes after Juvenile Diabetes Research Foundation’s (JDRF) extensive lobbying efforts to list T1 diabetes as a high risk condition alongside T2 diabetes (2).

As of now, the CDC’s vaccine recommendation includes frontline essential workers and people 75 years and older in Phase 1B. Persons 65 years and older and those at high risk for severe COVID-19 symptoms are included in Phase 1C. 

This can be seen as encouraging news for the autoimmune disease community, as health authorities begin taking certain high risk autoimmune diseases into account for vaccination priority. The rollout of Johnson & Johnson’s vaccine will undoubtedly aid these efforts by increasing vaccine availability. 

To find vaccine eligibility and prioritization criteria by state, view this resource by Kaiser Family Foundation. 

Autoimmune diseases reported to be triggered by SARS-CoV-2

March 4, 2021

The group at the Zabludowicz Center for Autoimmune Diseases of the Sheba Medical Center and the Laboratory of the Mosaic of Autoimmunity at Saint Petersburg State University have comprehensively investigated and reported the association between various common pathogenic viruses and the development of autoimmune and chronic inflammatory diseases. In light of the current global pandemic, they have also shifted their focus to include a recent (December 2020) review of the appearance of autoimmune diseases reported to be triggered by a SARS-CoV-2 infection. (1)

A list of Autoimmune Diseases and Autoantibodies associated with COVID-19 Infection

Table 1: Halpert, G., & Shoenfeld, Y. (2020). SARS-CoV-2, the autoimmune virusAutoimmunity reviews19(12), 102695. https://doi.org/10.1016/j.autrev.2020.102695

The Johnson & Johnson COVID Vaccine Receives Emergency Use Authorization by the FDA

March 2, 2021

The Johnson & Johnson COVID vaccine received emergency use authorization (EUA) by the FDA this past weekend. This single-shot vaccine is the third COVID vaccine to be released in the United States, with plans to deliver 16 million doses to the federal government by the end of March. Due to production issues, this will be significantly less than the 37 million dose figure released by Johnson & Johnson while recommendation by the FDA was still under review. The first 3.9 million doses, created in Johnson & Johnson’s Netherland factory, are expected to arrive in America by today, March 2 (2).

“A committee of independent advisors to the Centers for Disease Control and Prevention voted as expected to recommend distribution of the Johnson & Johnson vaccine to all adults in the United States” (2). That being said, it has not been decided whether states should prioritize this particular vaccine for certain population groups – including at-risk and immunocompromised groups – over others. 

The Johnson & Johnson vaccine has shown an 85% efficacy rate against severe COVID-19 cases, with complete protection against hospitalizations and death as of 28 days. A concern from officials and patients alike, it “appears to do well against the highly contagious B.1.351 variant” (3). 

In addition to being a single-dose, this vaccine can be stored in standard refrigerators instead of freezers, making it easier to transport and distribute. The Johnson & Johnson vaccine has also been shown to trigger less side-effects than Pfizer and Moderna; the side effects are usually more prevalent after the second dose has been administered (3). Again, this will not be an issue as Johnson & Johnson’s vaccine only requires one dose. That being said, Janssen Pharmaceuticals (owned and operated by Johnson & Johnson), instructs patients to let their medical provider know if they have “allergies… [and/or] are immunocompromised” before getting the Johnson & Johnson vaccine, and that “there is a remote chance that the Janssen COVID-19 vaccine could cause a severe allergic reaction… [usually] within a few minutes to one hour after getting a dose of the Janssen COVID-19 vaccine” (4). 

Check out this Vaccine Tracker by the New York Time for up-to-date information regarding vaccine research, production, testing and approval for around the world.

The VAXICOV study, autoimmune disease and vaccination concerns

February 25, 2021

The results of the international VAccinations against COVid-19 (VAXICOV) study were published this week, revealing patient concerns and expectations around receiving the COVID-19 vaccine.

Patients with systemic autoimmune or inflammatory rheumatic diseases were asked to participate in the online survey across 56 countries. Health care workers were also included as a control group.

The most commonly documented autoimmune conditions were systemic lupus erythematosus, spondyloarthritis, and rheumatoid arthritis. The median score for patients who reported “being afraid to get infected” with COVID-19 was 8, and afraid to “develop severe COVID-19” was 9 (1). That being said, only 54.2% of patients with systemic autoimmune or rheumatic disease were willing to get vaccinated against COVID-19 prior to seeing their specialist. 32.2% of patients were uncertain and 13% stated they were unwilling.

67.5% of patients were recommended by their specialist to get vaccinated – this is confirmation that the medical professional community at large is in favor of vaccinations for otherwise at-risk patients. Willingness to get vaccinated jumped to 67.5% post recommendation from their specialist. Uncertainty decreased to 28.4%, and unwillingness to 8.8%.

Additionally, the VAXICOV study confirms that patients with systemic autoimmune and inflammatory rheumatic diseases are generally willing to get vaccinated against COVID-19. “Willingness” to get a COVID-19 vaccine was associated with fear of getting a COVID-19 infection, not with fear around comorbidities or immunocompromised status. “These results show that a significant proportion of patients with systemic autoimmune or inflammatory rheumatic diseases who are at risk of severe COVID-19 do not perceive themselves as such, and highlight the importance of increasing patient education in this context” (1). Main concerns included a lack of context around COVID-19 vaccine data and testing, especially in regards to the new use of mRNA vaccines, as well as the risk of flare-ups and side effects.

Given the broad span of participants from across the globe, it is reasonable to consider these answers representative of the general population living with autoimmune and rheumatic diseases.

COVID-19, Autoantibodies, and Multisystem Inflammatory Syndrome in Children

February 23, 2021

Throughout the pandemic, cases have been reported of children experiencing a hyper-inflammatory response after a COVID-19 infection (1, 2). What was first described as a cluster of intense symptoms, has since come to be known as Multisystem Inflammatory Syndrome in Children (MIS-C). 

The pool of data around SARS-CoV-2 infection and MIS-C is still small, and a lack of consistency in clinical presentations of MIS-C make it easy for clinicians to misdiagnose symptoms for other conditions where hyperinflammation is prevalent, like Kawasaki disease, toxic shock syndrome, and macrophage-activation syndrome (MAS). Due to the general ambiguity around MIS-C’s cause and development, as well as its mechanisms for tissue damage, the CDC and WHO have constructed different clinical criteria for the diagnosis of MIS-C (3).

The American Academy of Pediatrics (AAP) recently published the results of an international survey detailing MIS-C cases from April-June 2020. Data was provided from 33 hospitals and included 183 pediatric patients ages 1.2 months to 18 years. In the clinical presentations of MIS-C, all patients presented with a fever (>100.4 F) and over 60% had gastrointestinal symptoms. The second most common symptom was cardiovascular. These findings coincide with previously published reports and classification criteria for MIS-C; other common clinical manifestations include dermatologic/ mucocutaneous symptoms, cardiovascular symptoms, respiratory symptoms, and neurologic symptoms (4). Examples can include rash, swelling of hands and/or feet, change to oral mucosa, pink eye, and swollen lymph nodes. It is unknown why a hyperimmune response occurs, and why autoantibodies against endothelial, gastrointestinal, and immune cells are produced. One study conducted by the Icahn School of Medicine found that MIS-C may share some pathophysiology with autoimmune disease. 

114 of the 183 patients included in the AAP survey tested positive for current or recent SARS-CoV-2 infection (3). Patients who did not test positive for COVID but presented symptoms concurrent to MIS-C may have experienced a COVID-19 exposure 2-6 weeks prior to the onset of symptoms (4). 

Continued research studying this occurrence will help to shed light on the long-standing damage this hyperimmune response may have on the body. Additionally, as criteria for clinical diagnosis is standardized, children experiencing MIS-C can have more immediate access to tailored therapies and treatment, to mitigate the often severe symptoms that accompany MIS-C. 

The Johnson & Johnson COVID Vaccine + Autoimmune Disease

February 16, 2021

In early February 2021, Janssen Pharmaceutical Companies of Johnson & Johnson requested emergency authorization by the FDA to distribute their COVID-19 vaccine. Come the end of the month, the FDA will be reviewing their request; if approved, the Janssen COVID-19 vaccine could be rolled out across the U.S. as early as the end of March. 

According to the press release on their website, this single shot vaccine is “85% effective overall in preventing severe disease, demonstrat[ing] complete protection against COVID-19 related hospitalization and death as of Day 28” (1). 

Within the trial, “moderate” COVID was defined as having received a lab-confirmed COVID diagnosis as well as experiencing the following symptoms: pneumonia, DVT (deep vein thrombosis), shortness of breath and/or abnormal oxygen and respiratory rates. “Severe” COVID includes “signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death” (1).

No anaphylaxis was observed during the clinical trials, and overall serious adverse events reported were actually higher from placebo groups than those who received the vaccine. While the population size was not released, it was confirmed that immunocompromised participants were in the study (1).

Janssen’s COVID-19 vaccine uses an inactive virus to deliver SARS-CoV-2 proteins to the body. These proteins are recognized as invaders by the body, signaling the production of antibodies as an immune response. This particular vaccine uses an adenovirus (which causes the common cold) as a vector (a device used to deliver genetic material) containing incomplete genetic material of the coronavirus. The genetic makeup cannot replicate; therefore, patients are not at risk for infection of SARS-CoV-2 from inoculation (2). 

Rheumatology International recently published a scientific review on the range of SARS-CoV-2 vaccines as they pertain to autoimmune inflammatory diseases. As of January 2021, there has been “no experience of viral-vector based vaccines against infectious agents in patients with [autoimmune inflammatory disorders]” (3). While this may spark initial concern, available data on vector-based vaccines in immunocompromised patients shows that these vaccines are not only well tolerated, but even more, severe adverse events are unlikely to occur (4). At the time of publication, only patients with rheumatic diseases have been included as an autoimmune disease population group in the most recent stage of clinical trials. While “well-known vaccines can provide guidance and partial confidence for the use of the ‘new vaccines,’” including more varied population groups going forward will ensure vaccine efficacy and safety for those living with autoimmune disease (3). 

The B.1.1.7 Coronavirus Variant

February 11, 2021

The B.1.1.7 coronavirus variant was first identified in the UK this past fall, emerging in Colorado soon thereafter. According to the CDC, there have been upwards of 1,000 cases caused by the B.1.1.7 variant across 34 states as of February 9, 2021. California and Florida, two states that have taken vastly different approaches for containing the novel coronavirus, have both reported the highest numbers of B.1.1.7 cases. 

While a preliminary report by the UK government’s NERVT advisory group indicates “there is a realistic possibility that…B.1.1.7 is associated with an increased risk of death,” research has yet to officially state if the B.1.1.7 variant causes more severe COVID symptoms (1). That being said, this variant has the potential to become the dominant strain of SARS-CoV-2, as its mutation is associated with a higher transmission rate than its predecessors. According to preliminary data, the B.1.1.7 variant is doubling in frequency every 9-10 days across the U.S. Moderna and Pfizer have released preliminary data verifying that their vaccines are likely to neutralize the B.1.1.7 variant; however, the efficacy rate may be negatively affected.

For regularly updated information and news on coronavirus mutations and variants, check out this comprehensive tracker created by The New York Times.

Scanning electron microscope image of SARS-CoV-2 emerging from the surface of cells.Scanning electron microscope image of SARS-CoV-2. Credit: NIAID-RML

 

clinical trial tests new antibody cocktail in patients with covid-19

February 10, 2021

On February 8, the NIH released a news statement announcing the implementation of a Phase 3 clinical trial for a new combination of antibodies as a therapy treatment for COVID-19.

“Antibodies are infection-fighting proteins naturally made by the immune system… [they] prevent viruses from infecting cells, usually by binding to the surface of the virus” (1). AZD7442 antibodies are the third antibody combination to be studied in patients currently hospitalized for COVID-19, being tested under a “master protocol” which allows investigators to trial multiple antibody combinations at the same time. This means less patients are receiving the placebo while providing a more robust pool of results on the efficacy of antibodies as a therapeutic measure.

AZD7442 antibodies work for a longer period of time once administered in patients infected with COVID, and may also function as a preventative measure against SARS-CoV-2.

Similarities Between COVID-19 and Autoimmune Disease

February 6, 2021

Recent studies have demonstrated the distinct relationship between the infectious disease COVID-19 and autoimmune disease. The review titled “COVID-19 and Autoimmune Diseases” by Yu Liu, Amr Sawalha, and Qianjin Lu delves into the most recent research on the similarities, which include: dysregulated immune responses, the promise of immunomodulatory drugs to treat both conditions, the detection of certain autoantibodies, and the development of autoimmune diseases after SARS-CoV-2 infection. Investigating the relationship between these diseases is critical in preventing and treating COVID-19, as well as understanding the risks for individuals living with autoimmune disease.

In some individuals, SARS-CoV-2 infection triggers immune system dysregulation with the overproduction and release of pro-inflammatory cytokines and, in effect, damage to one or multiple organ systems. Cytokines are proteins that signal the immune system to fight infection, but in excess they indicate the breakdown of self-tolerance. Similarly, autoimmune disease involves increased levels of pro-inflammatory cytokines, a loss of immune tolerance, and subsequent organ injury. As stated in the review, this parallel story between COVID-19 and autoimmune disease suggests that medications effective in treating autoimmune disease can have a similar impact on COVID-19. In fact, immunomodulatory drugs targeting excess cytokines (such as corticosteroids) are now being used to dampen the immune response in autoimmune disease as well as in severe COVID-19 in cases. While aiding in treatment of the disease, the fact that SARS-CoV-2 triggers immune dysregulation may also “have important implications in the development of vaccine strategies against this virus,” state the authors of the review (1).

Another likeness between autoimmune diseases and COVID-19 is the release of autoantibodies, which are proteins that can target and attack the body’s own immune system and organs (2). Antinuclear antibodies (ANA) and antiphospholipid antibodies (APL) are examples of autoantibodies found in both autoimmune disease and COVID-19 patients. The results of one study “showed that 45% of the [COVID-19] patients were positive for at least one autoantibody and patients with positive autoantibodies tended to have a worse prognosis” (1).

We are also beginning to learn that a loss of immune tolerance from COVID-19 can lead to full-blown autoimmune diseases such as Guillain-Barre syndrome (GBS) and systemic lupus erythematosus (SLE) (1). While more of these post-infection autoimmunity cases are likely to be discovered, researchers are still unsure whether individuals with preexisting autoimmune diseases are at higher risk of SARS-CoV-2 infection in the first place. Studies around the world have returned with conflicting results, and thus no clear consensus on the issue.

As the scale is poised to tip in either direction, the authors of the review urge autoimmune disease patients to continue physical distancing, washing their hands, wearing masks, and sticking to their medical protocols – including any prescribed immunosuppressive drugs – to prevent flare-ups and avoid potential organ damage. While there are still unknowns about COVID-19 and its connection to autoimmune diseases, the evolving clues about their relationship bring us hope in understanding and characterizing COVID-19.

The Development of Autoantibodies after Contracting COVID-19

February 3, 2021

While COVID-19 short-term impacts have been identified, the long-term effects of the disease are still widely unknown. Many new studies have shed some light on the potential long-term consequences of COVID-19, focusing on autoimmunity. A recent study from The University of Stanford School of Medicine directly links COVID-19 to autoimmunity and autoantibody development. This suggests that severe cases of COVID-19 can lead to a progression of “symptomatic classifiable autoimmunity in the future” (1). The linking of coronavirus to an increase in autoimmunity indicates significant concerns, especially for those with autoimmune diseases, whose immune systems are already impacted.

Many autoantibodies were found in this study’s COVID-19 patients, but the most common was Immunoglobin G (IgG) autoantibodies. IgG antibodies make up most of our blood’s antibodies, protecting us from infection, meaning that IgG autoantibodies pose potential threats as they could be pathogenic. The study used protein chips to track protein interactions that measure distinct IgG autoantibodies associated with connective tissue disease (CTD), anti-cytokine antibodies (ACA), and anti-viral antibody response.

This study’s findings signify that over 58% of the COVID-19 patients had at least one ACA that targeted interferons (IFN), which are proteins that inhibit virus replication. This emphasizes that the autoantibodies produced by infection from COVID-19 attack the vital proteins needed to protect the immune system. This study also measured autoantibodies levels throughout the patient’s sickness period, distinctly showing that the levels of autoantibodies increased in many patients over time. This is particularly important because it demonstrates that infection from COVID-19 can lead to the development of new autoantibodies.

Throughout this pandemic, many discoveries have been found, including one linking COVID-19 to autoimmunity. Such studies are leading scientists to a better understanding of the COVID-19 virus and the rise to autoimmunity and other diseases.

The P.1 Coronavirus Variant

January 25, 2021

A coronavirus variant (called P.1) that was first detected in Brazil was just confirmed by the Minnesota Department of Health as being the first documented case of the variant in the United States. (1) This variant has been particularly worrying scientists because of the mutations it has that let the virus spread faster and evade the immune system more effectively. This evolution could make it easier for COVID-19 survivors to contract the disease again and could potentially impede the effectiveness of vaccines. (2) While this is a daunting premonition, Marion Pepper, an immunologist at the University of Washington, wants us to remember that “even though everyone is obviously concerned about a virus evolving, your memory B cell responsiveness also evolves over time.” (3

So, let’s talk about these hero memory B cells how do they actually help fight our battles? The main function of the memory B cells is to retain and recall an infection (when presented with one that the body has experienced before) and react accordingly by producing corresponding antibodies. This sounds great, but what about when the body is presented with a new virus variant like the P.1 variant? The way these cells keep up with ever-evolving viruses is by randomly generating new antibodies that are similar to ones they’ve created in the past. (3) This essentially gives our immune system an unlimited defense arsenal. For more information on memory B cells, check out this great summary created at Arizona State University.

Blue and green colorized scanning electron micrograph of a human B cell.
Colorized scanning electron micrograph of a human B cell. Credit: NIAID, NIH

 

The mRNA Vaccine

January 19, 2021

These are truly novel times that we are experiencing, and the scientific community is no different. Interest in messenger RNA (mRNA) continues to grow within the medical community, especially since the developments of breakthrough COVID-19 vaccines. It is important to note that even after 30 years of research, mRNA vaccines have never before been approved for use in any disease, until now (1). However, researchers in Germany recently used mRNA technology to reduce disease activity in mice with Experimental Autoimmune Encephalomyelitis (EAE), a disease similar to multiple sclerosis (2).

mRNA vaccines involve using a small strand of distinct genetic material that carries the instructions for building a specific part of a cell. In the case of COVID-19, the mRNA vaccine contains instructions for building the virus’s “spike” protein. When a person receives the mRNA vaccine for the virus that causes COVID-19, their own cells are able to build the spike protein. This ramps up an immune system response against the virus. 

This response is especially important when it comes to battling the virus that causes COVID-19 because the SARS-CoV-2 virus in particular has the ability to dampen the immune system response while it is still replicating. This can lead to infected individuals spreading the virus to others while still asymptomatic. This technique has never been seen before. Virologist Benjamin tenOever of the Icahn School of Medicine at Mount Sinai stated that “it’s something I have never seen in my 20 years of studying viruses” when discussing the virus’ ability to commandeer cells’ genomes (3).

Although it may be quite a while before human clinical trials become a possibility, this research is significant. It shows the potential of mRNA vaccines to treat disease-specific autoimmunity without relying on therapies that suppress immune system function as a whole.

Vaccines and Autoimmune Disease

January 12, 2021

As distribution continues, experts are working diligently to uncover everything we need to know about the safety and efficacy of the emerging COVID-19 vaccines. The CDC advises the following: “People with autoimmune conditions may receive an mRNA COVID-19 vaccine. However, they should be aware that no data are currently available on the safety of mRNA COVID-19 vaccines for them. Individuals from this group were eligible for enrollment in clinical trials.” (1)

Despite lingering questions and uncertainties, there is one concern that researchers have been able to adequately address: Do vaccines cause autoimmune diseases? Check out Deplatform Disease’s article outlining what we already know about immunological function, autoimmune disease, and the science of vaccines. (2)

The illustration shows a coronavirus membrane decorated with spike glycoproteins. Red protein sequences indicate a potential target for vaccines to neutralize the coronavirus.
Credit: NIH Image Gallery

 

Increase in Coronavirus Variants and their Effects on the Vaccine

January 7, 2021

Recent developments concerning the COVID-19 virus are leading to an increase in questions and unknowns about it. While various vaccines are being distributed across the globe, recent findings on SARS-CoV-2 variants are worrying many. Some of these variants are known to spread faster and transmit more efficiently than other variants of the virus. Three of the most wide-spread variants are the UK variant (D614G), the Y453F mutation found in minks, and the N501Y cluster spreading in England. The research article “Genetic Variants of SARS-CoV-2—What Do They Mean?” explains that while the specific manifestation of these variants differs, the Y453F brings into question other evolutionary challenges, such as an abundance of a new COVID-19 from other mammals to humans. What makes these coronavirus variants even more worrisome is that they are advanced concerning “viral replication, transmission, and escape immunity,” making them even more difficult to contend with than the original COVID-19 virus (1).

One primary concern is the vaccine effectiveness of these variants. The variants are mostly mutations in the spike protein; therefore, scientists have to consider if the vaccines, which stimulate an immune response to the spike protein, are still effective. Thus far, the major consensus regarding vaccine effectiveness is that since current vaccines target the entire spike protein, they are effective regardless of the few changes in the variant. It is also important to note that while the mutations are considered efficient for the virus, they can make it inefficient in the future. To be certain, the evolution of SARS-CoV-2 must be carefully monitored over time. In addition, regulation of mask mandates and physical distancing guidelines is essential in stopping the spread of COVID-19 and all of its variants.

Understanding Long COVID

December 22, 2020

Signs or symptoms that continue or develop after a COVID-19 infection is known as long COVID. A recent study indicated that as many as 1 in 20 people will develop an illness that persists for weeks or months after they’ve had COVID-19. (1) Long COVID symptoms vary greatly from person to person, and in some cases, bear a close resemblance to autoimmune-related diseases like myalgic encephalomyelitis (ME/CFS).

Researchers across the world are working to answer key questions, like who is at risk for long COVID? What is the link between COVID-19 and autoimmune disease? What are the most useful treatments for long COVID? Check out our latest article, “Understanding Long COVID” for a breakdown of this condition and how the experts are working to address it.

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