FDA plans to authorize Pfizer boosters for all adults this week
WASHINGTON» The Food and Drug Administration is aiming to authorize booster doses of Pfizer-biontech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans.
The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the FDA and the CDC sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older.
Under that scenario, any adult who received a second dose of the vaccine at least six months earlier would be officially eligible to get a booster as soon as this weekend. The FDA is expected to rule without consulting its own expert panel, which has met frequently during the pandemic to review vaccine data and make a recommendation ahead of a regulatory decision.
The broad booster authorization has been viewed as something of a fait accompli for weeks. Some state and local officials have begun rolling out similar policies ahead of FDA action — responding to persistent virus case counts, including some breakthrough cases, and the eagerness of many Americans to seek additional protection ahead of holiday gatherings.
New York City health officials on Monday encouraged all adults who want boosters to seek them out. Arkansas, California, Colorado and New Mexico have also moved to expand access.
Many Americans, regardless of where they live, have taken the matter into their own hands and sought out extra doses even if they did not yet officially qualify.
The FDA in September downsized an initial request from Pfizer-biontech to fully approve booster doses for all adults. Instead, it made a more limited population eligible, including those 65 and older, as well as adults with underlying medical conditions or those at risk because of their jobs.
At least 30% to 40% of vaccinated adults are still excluded from booster eligibility, according to some estimates.
More than 30 million people have already gotten additional shots, with the daily number often outpacing that of first shots given around the country. Booster doses were also authorized in October for everyone who received the single-dose Johnson & Johnson vaccine, and for vulnerable groups who received Moderna’s two-dose shot.
The CDC’S gathering on Friday is scheduled to be briefer than recent meetings about COVID-19 vaccines, just three hours. It is expected to be straightforward, one federal official familiar with the planning said, in part because of how far the nation’s booster campaign has already come. That would suggest a significant softening of opposition among public health experts since President Joe Biden announced in August that he hoped to offer booster doses to all adults.
Biden wanted to start the campaign in late September, but his announcement was heavily criticized by public health experts, who said he was rushing federal scientists and regulators responsible for deciding whether the data supported such a move.