WASHINGTON — A federal health advisory panel wrestled Friday with whether to widely authorize a booster dose of Pfizer’s two-shot COVID-19 vaccine for most Americans, ultimately recommending that a third dose be offered only to older or higher-risk individuals.
The Biden administration had hoped that states could begin rolling out a wide national booster shot campaign as soon as Monday, and the Food and Drug Administration advisory committee’s decision threw up a roadblock for that goal.
Medical experts on the FDA panel debated the question for hours and expressed skepticism about whether the available data on effectiveness and safety warrant urging every vaccinated American to get another shot.
All but two of the panel’s 18 voting members rejected Pfizer’s request that the company be allowed to offer extra doses to anyone 16 and older, six months after their second dose.
The revised recommendation instead calls on the FDA to allow booster shots for those 65 and older, or at high risk of a severe COVID-19 infection.
The panel’s recommendation is non-binding, but typically followed by top agency officials.
Still, questions remain to be answered, including what happens next for Americans who got shots produced by the other authorized COVID-19 manufacturers, Moderna and Johnson & Johnson.
Interpreting who exactly is at high risk of severe COVID-19 — such as health care or other front-line workers — will be up to an advisory panel for the Centers for Disease Control and Prevention, which is set to meet Wednesday and Thursday.
That panel’s recommendation will come after the Sept. 20 date that the Biden administration targeted for a national booster shot campaign.
President Joe Biden and his pandemic advisers announced the administration plan for boosters in mid-August, leapfrogging the federal regulatory panels as the administration sought to tamp down another rise in infections and hospitalizations.
Administration officials said the booster plan was announced early to give states time to prepare for another round of shots. But the public announcement appeared to irritate FDA officials involved in the approval process.
Two of the agency’s top vaccine scientists have said they will retire this fall — with the booster process a contributing factor in that decision, according to multiple news reports.
As federal health officials have scrambled to assess data on whether booster shots are needed, the country has been facing a fourth wave of cases, with an average of 145,000 infections and 1,300 deaths per day.
The overwhelming majority of current COVID-19 cases, hospitalizations and deaths are among people who have not received a vaccine against the disease.
But a series of studies have suggested that while the protection offered by the three COVID-19 vaccines has remained strong against severe infections, that protection has waned when it comes to asymptomatic or mild infections. Read more