The Johnson & Johnson COVID Vaccine + Autoimmune Disease
February 16, 2021
In early February 2021, Janssen Pharmaceutical Companies of Johnson & Johnson requested emergency authorization from 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 the 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).