The Food and Drug Administration is likely to authorize Pfizer-BioNTech booster shots this week for many Americans at high risk of falling seriously ill from the coronavirus, now that a key advisory committee has voted to recommend the measure.
On Friday, a panel of experts endorsed offering Pfizer booster shots for people 65 and older, and for people 16 and older who are at high risk of getting severe COVID-19 or who work in settings that make them more likely to get infected.
The agency, which often follows the committee’s advice but is not required to, is expected to decide early this week. An advisory committee of the Centers for Disease Control and Prevention is scheduled to meet Wednesday and Thursday to discuss booster shots before that agency — which sets vaccine policy — issues its recommendations.
On Monday, Jen Psaki, the White House press secretary, defended the federal regulatory process for signing off on booster shots and urged patience from those eager for an additional dose.
“That process is in place for a reason so that you can trust what the final recommendation and the final outcome is,” she said, noting that President Joe Biden would receive a booster shot on camera after they are cleared by federal regulators.
The decision on Pfizer booster shots is just one of a series of key questions that the agency is expected to consider in coming weeks. Officials have said they expect to soon have data on whether boosters are needed for people who got the Moderna and Johnson & Johnson vaccines.
Also expected this fall is a decision on a shot for children ages 5 to 11, an intensely watched issue given that about 48 million children are not yet eligible for a vaccine but have largely returned to classrooms.
On Monday, Pfizer said a trial showed that its vaccine produced a strong immune response in children ages 5 to 11. Pfizer and BioNTech plan to apply to the FDA by the end of the month for authorization to use the vaccine in these children. If the regulatory review goes as smoothly as it did for older children and adults, millions of elementary school students could be inoculated before Halloween. Officials have said they expect results from Moderna’s children’s trial later this fall.
Interviewed on Sunday-morning news shows, Dr. Anthony Fauci, the nation’s top infectious disease doctor and an adviser to Biden, asked Americans to be patient and not to get a booster shot until they were eligible. That includes people 65 and older who received the Moderna and Johnson & Johnson vaccines.
“We’re working on that right now to get the data to the FDA, so they can examine it and make a determination about the boosters for those people,” he said on NBC’s “Meet the Press.” “They’re not being left behind by any means.”
Last month, the Biden administration proposed a plan that would have made vaccinated Americans eligible who received the Pfizer and Moderna vaccines for a booster shot eight months after their second shot. Officials had also hoped to get boosters to recipients of the one-shot Johnson & Johnson vaccine as more data came in.
But the expert panel concluded that boosters were not necessary for most younger, healthier Americans, unless their jobs put them at special risk for infection.
Jobs in that category would include health care workers, emergency responders and teachers, according to Dr. Peter Marks, who oversees the FDA’s vaccine division.
Whatever the FDA decides about boosters this week, Fauci predicted it will probably be revised as more data comes in.
“In real time, more and more data are accumulating,” he said on ABC’s “This Week.” “There will be a continual reexamination of that data and potential modification of recommendations.”
Dr. Francis Collins, director of the National Institutes of Health, echoed those remarks on CBS’ “Face the Nation,” saying that the category of who is eligible for an extra shot was likely to be expanded in the “coming weeks.”
FDA officials will also spend the coming weeks and months evaluating vaccines for children under 12. On Sunday on ABC, Fauci said a decision on children’s vaccines would certainly come “this fall,” adding, “sometime in the mid- to late fall, we will be seeing enough data from the children from 11 down to 5 to be able to make a decision to vaccinate them.” A decision on vaccines for children under 5 would come after that.
The flurry of decisions comes as public health officials hope to avoid a repeat of last fall and winter, when a surge of infections led to peak levels of hospitalizations and deaths in the United States.
The extremely transmissible delta variant now accounts for more than 99% of cases tracked in the country, according to the CDC. Although hospitalizations and new cases have started to trend slowly downward, deaths have topped an average of 2,000 a day for the first time since March 1, according to a New York Times database. Vaccinations have been shown to protect against severe illness brought on by the variant.
Fauci said Sunday that the key to avoiding a fall and winter surge would be encouraging adults who were eligible but still unvaccinated to change their mind.
“I believe if we get that overwhelming majority of the people vaccinated as we enter into the fall and winter, we can have good control over this and not have a really bad winter at all,” he said on “Meet the Press.”