FDA Authorize Boosters for Some as CDC Expert Panel Considers Who Should Get Them

The FDA yesterday authorized booster shots of the Pfizer-BioNTech COVID-19 vaccine for people over 65 who have been vaccinated at least six months earlier with the two-dose shot.

The agency also updated Pfizer’s Emergency Use Authorization for booster shots for previously vaccinated individuals at risk of serious infections because of frequent exposure to the coronavirus in their workplace and for those younger than age 65 who are at high risk of severe infection due to existing comorbidities.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” Acting FDA Commissioner Janet Woodcock said in announcing the agency’s decision.

The FDA’s announcement came after the Biden administration had announced in mid-July that it would begin offering boosters to the general population Sept. 20.

A Centers for Disease Control and Prevention (CDC) expert panel said yesterday after a full day’s discussion that it would not make recommendations for who should get COVID-19 boosters until the FDA first made its decision on who should get the shots. That conclusion was made prior to the FDA’s decision on boosters late in the day.

The CDC’s Advisory Committee for Immunization Practices (ACIP) meets again today and may make recommendation on which groups in the general population should receive a booster now that the FDA has authorized boosters for some segments of the population. But inoculations can begin even if the CDC’s panel does not recommend boosters.

Last week, an FDA advisory panel declined to recommend approving a Pfizer/BioNTech COVID-19 vaccine booster for the general population. But the Vaccines and Related Biological Products Advisory Committee (VRBAC) voted unanimously 18-0 to recommend granting an updated Emergency Use Authorization allowing boosters in those 65 years and older and those at high-risk of progressing to severe disease because of existing comorbidities. The expert panel also recommended that frontline healthcare workers should get a third shot (DID, Sept. 20).

“We appreciated the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in announcing the FDA’s decision on boosters — for now. The agency has made clear that it may change its authorization on who can get the boosters as more data become available in coming weeks and months.

Summarizing the ACIP’s findings yesterday, Sara Oliver, an epidemic intelligence service officer within the CDC’s division of viral diseases, concluded that a booster may induce extra protection against infection for older populations, specifically those in nursing homes, and that vaccinating nursing home staff was also key for protecting this vulnerable population.

In addition, several ACIP panelists discussed whether mixing and matching booster shots with different vaccines would be a good idea. However, Doran Fink, the FDA’s deputy director of clinical within the division of vaccines and related products applications, remarked that the agency currently has no data to support such a use.

Until late yesterday, the only FDA-authorized segment of the population eligible to receive a COVID-19 booster are certain immunocompromised individuals, who can receive either a third Pfizer/BioNTech or Moderna shot (DID, Aug. 12). ― Jason Scott