FDA panel limits COVID booster recommendation to elderly, high-risk
An advisory panel to the US Food and Drug Administration (FDA) has overwhelmingly voted against recommending a broad COVID-19 vaccine booster program for all American adults at this time. Instead, the panel unanimously recommended boosters for those in high-risk groups or over the age of 65.
In mid-August the White House announced plans for a large COVID-19 vaccine booster program commencing in late September. The plan was to offer all Americans over the age of 16 a third vaccine shot.
The unusual announcement preceded any formal recommendations from independent FDA or CDC panels convened to determine the safety or effectiveness of vaccine booster programs. On Friday, September 17, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to consider the proposal and officially voted against recommending the government’s broad booster program.
The panel spent hours reviewing the data on COVID-19 boosters, with presentations by both Pfizer and scientists from Israel arguing for broad administration of third doses in all adults at this current time. Data from Israel, which began administering booster shots to all adults over the age of 16 in late July, suggests third doses significantly improve waning protection against COVID-19 infection.
However, the VRBPAC ultimately voted against recommending boosters for all adults, with a majority of 16 for and only two against. The two main factors cited in the decision were the lack of safety data for third vaccine doses in young adults and strong evidence showing current vaccine protocols are still significantly effective against severe disease, hospitalization and death.
"A third dose is likely beneficial," said VRBPAC panelist and Harvard scientist Ofer Levy. "That's already true for the immunocompromised. It's likely beneficial, in my opinion, for the elderly and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data."
The committee did unexpectedly vote on another booster proposal during the meeting. In a unanimous vote the committee recommended boosters be administered to those over the age of 65 and those in certain high-risk categories.
An upcoming meeting of the CDC’s Advisory Committee on Immunization Practices will clarify exactly who those high-risk groups will be. It is likely they will cover those with medical vulnerabilities but also potentially include certain occupations such as healthcare workers and teachers.
VRBPAC’s decision is only a recommendation but it is unlikely the FDA will not follow the advice. Anthony Fauci, the White House chief medical adviser, says VRBPAC’s recommendations were “good” but “not the end of the story.” Fauci, who co-signed the August White House announcement calling for a broad booster program, says the issue of third vaccine doses is more likely a question of when rather than if.
“I don’t think they made a mistake, but people need to realize that data is coming in, literally on a daily and weekly basis, and they’re going to continue to look at this literally in real time,” Fauci said to CNN following the decision. “It is entirely conceivable and maybe likely that ultimately the proper regimen for protection, optimal protection and durability of protection would be more than just the prime and the boost followed by three to four weeks, that it might actually entail a third boost.”
In response to the VRBPAC decision the White House said those elderly and high-risk groups would have initially been prioritized for booster shots anyway, so if the FDA moves ahead with the program as recommended the coming weeks will essentially play out as initially planned back in August.
"Today was an important step forward in providing better protection to Americans from COVID-19," said Kevin Munoz, White House spokesman. "We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week."