FDA Expected to Authorize 3rd Dose of COVID Vaccine for Immunocompromised People

The Food and Drug Administration is expected to announce Thursday (or shortly thereafter) that it is authorizing a third dose of the COVID-19 vaccine for certain people with weakened immune systems, according to people familiar with the FDA’s plans.

The plans were first reported by NBC News and confirmed by CNN and Politico.

The FDA is expected to give the green light for a third dose of Moderna and Pfizer / BioNTech mRNA vaccines. The authorization of the third injections would go through the updating of the authorizations for emergency use of the vaccines.

Johnson & Johnson’s unique COVID-19 vaccine is excluded from the update. According to Politico sources, this is because federal officials believe that very few immunocompromised people have actually received the Johnson & Johnson vaccine. The shot was cleared long after immunocompromised people were initially eligible for vaccination and healthcare providers have since recommended that immunocompromised seek Moderna or Pfizer / BioNTech vaccines.

The third doses of the two mRNA vaccines are expected to help strengthen protection in immunocompromised people, including cancer patients, organ transplant patients and people living with HIV. Studies have shown that people with weakened immune systems, including those taking immunosuppressive drugs, produce relatively weak immune responses after two standard doses, and a third dose may help.

Reinforced protection

Researchers published the results of a double-blind randomized controlled trial involving 120 organ transplant recipients on Wednesday in the New England Journal of Medicine. The trial found that those who received a third dose of Moderna vaccine had “significantly higher” levels of antibody and virus neutralization than the placebo group, which received only two doses. Likewise, a smaller study published last month in the Annals of Internal Medicine found that a third dose of vaccine could produce an antibody response even in some transplant recipients who did not have detectable antibody levels after. the second dose.

At this time, it is not known which groups of immunocompromised patients will be allowed to receive a third dose. It is estimated that 7 million adults in the United States are immunocompromised overall.

“We were concerned about these [immunocompromised] individuals, ”Surgeon General Vivek Murthy told CNN Wednesday afternoon. “The FDA has worked hard to basically do the safety assessment, to make sure we have everything we need to make these extra doses available to people. The CDC also seeks to ensure that the guidelines are clear and available for people with immunosuppression. “

Once the FDA clears the change, an advisory committee for the Centers for Disease Control and Prevention will establish formal federal recommendations for the administration of the third doses. This committee – the Advisory Committee on Immunization Practices (ACIP) – has already scheduled a meeting for this Friday, August 13, during which committee members will discuss additional doses of COVID-19 vaccines for immunocompromised people.

The World Health Organization called for a temporary moratorium on COVID-19 booster injections, but said the moratorium did not apply to additional doses needed for people with compromised immunity.