The FDA Is Not Authorizing a Booster for This One Vaccine
The agency has now approved extra doses of COVID shots for certain individuals.
Booster vaccines have been a topic of conversation since COVID shots began, as research shows that immune response can diminish over time, particularly in the face of more infectious variants. White House COVID adviser Anthony Fauci, MD, recently acknowledged that everyone will likely need a COVID vaccine booster eventually, but some will need it sooner than others. Now, the U.S. Food and Drug Administration (FDA) has decided to approve booster vaccinations for certain people, but not every vaccine will be asked to provide extra doses.
On Aug. 12, the FDA announced that they had authorized an additional vaccine dose for certain immunocompromised individuals—specifically, "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromised," the agency said. Only about 2.7 percent of U.S. adults are immunocompromised, per the Centers for Disease Control and Prevention (CDC).
"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," Janet Woodcock, MD, the acting FDA commissioner, said in a statement. "Today's action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19."
But the FDA has only amended the emergency-use authorizations (EUA) for two vaccines: Pfizer and Moderna. The agency's announcement made no mention of the Johnson & Johnson vaccine. According to The New York Times, the FDA has decided not to broaden the EU of the single-dose vaccine, partly because officials still want to see Johnson & Johnson's clinical trial data on the safety and efficacy of two doses first. The vaccine manufacturer is expected to release those results this month.
The FDA emphasized that this decision for an additional dose "does not apply to people who are not immunocompromised." Immunocompromised individuals who received either the Pfizer or Moderna vaccine are permitted to receive a third, additional dose administered at least 28 days following their second dose. But they must receive the same vaccine they got for their first two shots.
This amendment follows several studies over the past months that have shown immunocompromised people might benefit from an additional shot due to a lackluster immune response to just two doses. A May study published in the Journal of the American Medical Association found that almost half of organ transplant recipients produced no COVID antibodies following two doses of either mRNA vaccine, while a recent Canadian study found that a third dose of the Moderna vaccine significantly improved the immune response for this group. Another pre-print of a study released on medRxiv in July determined that about 44 percent of those hospitalized with breakthrough cases in the U.S. are immunocompromised.
"People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19," the agency's statement reads. "The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in these individuals and determined that the administration of third vaccine doses may increase protection in this population."
The CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet Aug. 13 to "discuss further clinical recommendations regarding immunocompromised individuals," according to the FDA's announcement.