FDA Authorizes Additional Dose for Immunocompromised Patients

August 13, 2021

Last night, the FDA authorized the 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.