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 F.D.A. If the C.D.C. and F.D.A. sign off this week they will have acted quickly. 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.
This scenario would allow any adult who had received a second dose of vaccine at least six month earlier to be eligible for a booster as soon this weekend. The F.D.A. The F.D.A. is expected to make its decision without consulting its own expert panel. This panel has met often during the pandemic to review vaccine data, and make a recommendation before a regulatory decision.
The broad booster authorization has been seen as a given for several weeks. Several state and local officials have started to implement similar policies before F.D.A. 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.
Monday was Monday for New York City health officials who encouraged boosters-seeking adults to go to them. New Mexico, Colorado, Arkansas, and California have all expanded access.
Many Americans, no matter where they live, have taken the matter into themselves and sought additional doses even though they weren’t officially qualified.
F.D.A. in September downsized an initial request from Pfizer-BioNTech’s to fully approve booster doses for all adults. Instead, it made a limited population eligible, including people 65 and older, aswell as those with underlying medical conditions, or those at high risk because of their jobs.
Some estimates suggest that booster eligibility is still denied to at least 30-40 percent of vaccinated adults.
Over 30 million people have received additional shots. The daily number is often higher than the number of first shots across 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 C.D.C.’s gathering on Friday is scheduled to be briefer than recent meetings about Covid 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. This would suggest that there has been a significant shift in public health experts’ attitudes since August, when President Biden stated that he planned to offer booster doses to all adults.
Although Mr. Biden had hoped to launch the campaign in September, his announcement was heavily criticised by public health experts who claimed he was hurrying federal scientists and regulators to decide whether the data support such a move.
Key regulators and advisers had argued strongly that the two-dose regimen’s effectiveness, especially in preventing death and hospitalization, has not diminished. A New York study of nearly nine million people showed remarkable durability in the protection provided by all three federally approved vaccines.
But more recently, some federal regulators and scientists have said the evidence is increasingly clear that a reduction in vaccine efficacy against milder Covid cases, and in protective antibodies, has put Americans — especially seniors and those with medical conditions — at risk of harmful breakthrough infections as the Delta variant of the virus only gradually loosens its grip.
BioNTech and Pfizer stated last week that their request was based on data from a clinical study in the United States that involved more 10,000 volunteers. After a third dose, the vaccine’s efficacy rate against symptomatic disease had been restored to about 95 percent, they said. However, it is not known how long the booster shot will protect.
Moderna is expected soon to submit its own request for F.D.A. to increase eligibility for the booster. According to people familiar with the planning, for now, any adult can get the Pfizer boost if it is widely authorized.
Top federal health officials, including Dr. Anthony S. Fauci, have argued for months — often pointing to Israel, which started its booster campaign in late July and now offers extra shots to everyone 12 and older — that the case for boosting widely in the United States is clear. On Tuesday, Dr. Fauci told Reuters that the virus could be contained in the United States by the spring if boosters are made available for everyone.
Experts in vaccine have stated that antibody protection can only be one measure of how a vaccine confers safety. However, Covid vaccines are expected to lose their effectiveness. Some have warned that keeping antibody levels high would possibly require regular booster shots — a standard that would be difficult to sustain.
What you need to know about Covid Vaccines & Boosters
Experts agree that giving the first doses to those who are not vaccinated is more important than boosting.
While the F.D.A.’s expert committee is not expected to weigh in before the agency’s ruling, several members said last month at a meeting discussing booster shots that the agency should go ahead and lower the age eligibility.
A study in Israel published in The Lancet in October found that people who received a booster dose of the Pfizer BioNTech vaccine in August or September had a lower chance of severe illness.
Israeli officials reported to an F.D.A. Last month, officials from Israel reported at an F.D.A. meeting that third doses hadn’t caused any significant safety concerns. Pfizer was expected present this finding to the F.D.A. in its request to increase eligibility. Friday’s meeting of the C.D.C. The panel will likely review data provided by the company on side effects. Regulators were particularly concerned about possible links between Moderna and Pfizer BioNTech vaccines. Myocarditis is inflammation of the heart muscle that has been seen in younger men who received two doses.
A. Oveta Fuller (associate professor of microbiology, immunology, and microbiology at Michigan) is a member of F.D.A. According to the committee, although she was initially skeptical about clearing booster shots for so numerous adults based heavily upon data from Israel, she is now more convinced that millions have received the extra shots.
“Caution is always better,” she said. She said that if there were more adults who could get boosters, it would make the message about booster shots easier to understand.
Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the F.D.A. advisory committee, said that the American booster campaign thus far had been “helter-skelter.”
“Each of us have our own personal psychology and risk tolerance and belief systems, and people are moving sometimes backed by data, sometimes backed by emotion, fear,” he said.
Source: NY Times