Update 8/13/2021 9:30 am ET: Just before midnight on Thursday, the Food and Drug Administration updated the emergency use authorizations for both the Pfizer/BioNTech and Moderna COVID-19 vaccines, allowing immunocompromised people to receive a third dose of vaccine at least 28 days following the two-dose regimen to further boost protection. The FDA said the change applied specifically to "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."
In a statement, Acting FDA Commissioner Janet Woodcock said, “The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines."
Woodcock further emphasized that, for now, only certain immunocompromised people need an additional dose. "As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.” Health officials expect that booster shots may be needed for the general population at some point in the future, but it's unclear when.
The CDC's Advisory Committee on Immunization Practices (ACIP) will meet later today to make clinical recommendations for administering the third doses for immunocompromised people. The original story follows.
8/11/2021 8:16 pm ET: The Food and Drug Administration is expected to announce Thursday (or soon after) that it is authorizing a third COVID-19 vaccine dose for some people with compromised 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 a green light for a third dose of both the Moderna and Pfizer/BioNTech mRNA vaccines. The authorization for the third shots would come by way of updates to the vaccines' emergency use authorizations.
Left out of the update is Johnson & Johnson's one-shot COVID-19 vaccine. According to Politico's sources, this is because federal officials believe very few immunocompromised people actually received the Johnson & Johnson vaccine. The shot was authorized well after immunocompromised people were initially eligible for vaccination, and health care providers have since recommended that the immunocompromised seek the Moderna or Pfizer/BioNTech vaccines.
The third doses of the two mRNA vaccines are expected to help boost protection in the immunocompromised, which includes cancer patients, organ-transplant patients, and people with HIV. Studies have found that people with compromised immune systems, including those taking immunosuppressive drugs, produce relatively poor immune responses after two standard doses—and that a third dose can help.
Boosted protection
Researchers published results Wednesday in The New England Journal of Medicine on a double-blind randomized controlled trial involving 120 organ-transplant recipients. The trial found that those who received a third dose of the Moderna vaccine had "substantially higher" levels of antibody and virus neutralization than the placebo group, which had only received two doses. Likewise, a smaller study published last month in the Annals of Internal Medicine found that a third vaccine dose could produce an antibody response even in some transplant recipients who had no detectable antibody levels after the second dose.
For now, it's unclear which groups of immunocompromised patients will be authorized to receive a third dose. An estimated 7 million adults in the US are immunocompromised overall.
"We've been concerned about these [immunocompromised] individuals," Surgeon General Vivek Murthy said Wednesday afternoon on CNN. "The FDA has been working hard to basically do the evaluation around safety, make sure that we have everything we need to make these additional doses available to people. The CDC is also looking into making sure that guidance is clear and available for immunocompromised individuals."
Once the FDA authorizes the change, a committee of expert advisers for the Centers for Disease Control and Prevention will set official federal recommendations for administering the third doses. That committee—the Advisory Committee on Immunization Practices (ACIP)—has already planned a meeting for this Friday, August 13, in which committee members will discuss additional doses of COVID-19 vaccines for immunocompromised individuals.
The World Health Organization has called for a temporary moratorium on COVID-19 booster shots, but it has said that the moratorium does not apply to necessary extra doses for immunocompromised people.
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