Update: FDA Authorizes mRNA Booster Shot for Immunosuppressed Individuals

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Note: this article has been updated with new information that became available on August 12, 2021.

The US Food and Drug Administration (FDA) on August 12, 2021, announced an amendment to the emergency use authorizations (EUAs) granted for COVID-19 vaccines from both Pfizer-BioNTech and Moderna to allow use of an additional dose in "certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise," according to an agency statement.

The Centers for Disease Control and Prevention's Advisory Council on Immunization Practices will meet today as planned to discuss additional recommendations regarding immunocompromised persons.

It is important to note that the FDA statement reiterates the information below, offered by Dr Anthony Fauci, MD: Today’s action does not apply to people who are not immunocompromised.

Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, while speaking this morning on NBC’s “Today” show, said that the third or booster shot, which he expects the FDA to move on “imminently,” will be recommended for those who have been fully vaccinated but whose immune response is weakened by immune-suppressing treatment for cancer or other disease or for organ transplants, according to a report from the Associated Press.

The consideration comes as findings mount to suggest that COVID-19 variants are more likely to arise from patients whose partial immune response prevents full recovery from COVID-19 infection, creating an environment for immune selection pressure in favor of more “transmissible or more pathogenic SARS-CoV-2 variants,” according to authors of an article published in the New England Journal of Medicine.

“The virus can persist for weeks or months in immunocompromised individuals, leading to viruses that carry a constellation of mutations – they sometimes look like the variants of concern that are currently threatening to our control efforts,” said Morgane Rolland, PhD, a viral geneticist with the US Military HIV Research Program at Walter Reed Army Institute of Research and senior author of the article, in a press statement.

“The medical community needs to develop more precise guidelines for monitoring, treating and preventing COVID-19 infections in immunosuppressed patients to reduce both the risk to these patients and the potential emergence of variants of concern,” said Larry Corey, MD, virologist at Fred Hutchinson Cancer Research Center and leader of the COVID-19 Prevention Network, in the statement.

Asked during the “Today Show” interview about additional immunization for other high-risk groups, such as the elderly or those living in extended care facilities, Fauci referred to ongoing data gathering across a range of vulnerable populations that will identify whether or when vaccine protection drops below a “critical level,” and “that’s when you’re going to be hearing about the implementation of boosters” for other groups.

He also pointed out that while an FDA decision will support booster shots now only for those who are immunosuppressed, the time will come when we will all “have to get boosts” because “no vaccine, at least not within this category, is going to have an indefinite amount of protection,” reported the Associated Press.

The Advisory Committee on Immunization Practices of the CDC will meet on Friday, August 13, 2021, to discuss additional COVID-19 doses for immunocompromised individuals.