FDA on Thursday is expected to amend the emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines to allow immunocompromised adults to receive an additional dose, sources familiar with the decision told Politico and the New York Times.

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Background

According to Axios, research indicates that people with weakened immune systems do not generate sufficiently high levels of protection against the coronavirus with the mRNA vaccines' initial two-dose regimen—but several smaller studies indicate that a third dose could help substantially.

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For instance, a study published in the New England Journal of Medicine on Wednesday found that patients who had received a solid-organ transplant experienced a significant increase in protection after they received a third mRNA vaccine dose, Politico reports.

Overall, according to CDC, there are roughly 7 million adults who qualify as immunocompromised, including solid-organ transplant patients, patients with cancer, and patients with HIV.

Amendment details

According to the Times, an official close to the decision said the amendments will allow providers to recommend people who have had solid-organ transplants or whose immune systems are similarly compromised receive an additional vaccine dose of either Pfizer-BioNTech or Moderna's vaccine.

Notably, sources close to the matter told Politico and the New York Times, among other news outlets, that only the EUAs for the mRNA vaccines will be amended to allow for additional doses; the agency does not plan to amend the EUA for Johnson & Johnson's (J&J) single-dose vaccine.

According to Politico, officials said they opted against expanding J&J's EUA because they believe relatively few immunocompromised adults received that vaccine, as it was authorized "well after" immunocompromised patients were permitted to receive one of the two authorized mRNA vaccines. Moreover, CDC has "long recommended" that immunocompromised people receive Pfizer-BioNTech or Moderna's vaccine, Politico reports.

Further, one official told the Times that public health officials are waiting to broaden J&J's EUA at least until J&J releases its clinical data on the safety and efficacy of receiving two doses of its vaccine—data which is expected to be released later this month.

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According to officials, the amended EUAs will not apply to otherwise healthy individuals who have been fully vaccinated. However, some Biden administration officials have indicated they are assessing whether more vulnerable members of the general population may eventually need booster shots, the New York Times reports—although several scientists and public health experts say the data does not yet indicate a booster shot for otherwise healthy, fully vaccinated populations is necessary.

ACIP to meet on Friday

CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on Friday to assess the latest data on providing an additional vaccine dose for immunocompromised individuals, Politico reports. The panel in July held off on recommending booster doses, Politico reports, largely because FDA had not yet authorized the vaccines for that purpose.

The committee is expected to formally recommend the practice tomorrow. However, while the anticipated approval is a critical endorsement of FDA's anticipated EUA amendments, the panel's recommendation is not required before additional doses can be administered, according to Politico.

Comments

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the White House's chief medical adviser, last week indicated the Biden administration was moving to issue these amendments, The Hill reports. During a White House briefing, he said, "It is extremely important to us to get those individuals their boosters, and we are now working on that and will make that be implemented as quickly as possible because for us and for the individuals involved, it is a very high priority."

Leana Wen, an ED physician and public health professor at George Washington University said FDA should go further, amending the EUAs for all three vaccines and issuing broader criteria to permit additional doses.

"I understand why to some extent the FDA may be hesitant to make a broad recommendation to 13 million people without definitive evidence," Wen said, referring to the number of Americans who have received the J&J vaccine. "But that's why they should allow people to get the advice from their individual doctors to get a booster dose. ... Why don't we allow them to do this in a way where they're not sneaking around?"

For its part, FDA in a statement to The Hill said, "The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals. The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future." (Vakil, The Hill, 8/11; Cancryn/Gardner, Politico, 8/11; LaFraniere/Weiland, New York Times, 8/11; Saric/Owens, Axios, 8/11)