A day after federal regulators authorized Pfizer-BioNTech coronavirus booster shots for Americans at risk of severe Covid-19, scientific advisers to the Centers for Disease Control and Prevention on Thursday recommended the booster shots for a wide swath of the country, including tens of millions of older Americans and those with certain medical conditions. But the panel excluded those at risk because of their jobs.
The Food and Drug Administration on Wednesday authorized boosters for older and high-risk recipients of the Pfizer vaccine at least six months after their second injection, as well as for people whose jobs leave them exposed to the virus, including health workers, teachers and grocery workers.
The C.D.C.’s science advisers unanimously supported the booster for adults older than 65 and for residents of long-term care facilities. And 13 of the committee’s 15 members also endorsed the shots for people aged 50 to 64 years with medical conditions that leave them at risk for severe Covid-19.
Some members urged the committee to include some flexibility for individuals under 50 to obtain boosters, based on their individual benefit and risk. But others pointed — with considerable frustration — to a lack of data supporting the need in the other groups.
After a protracted discussion, a majority of the panel recommended the boosters for adults aged 18 to 49 years with underlying medical conditions, based on their individual benefit and risk.
They disagreed most on whether some people in some occupations or settings are at heightened risk. By a close vote of nine to six, they voted to exclude people at risk because of their occupations. This measure would have applied to health care workers, teachers and other workers who do not meet the other criteria.
The Pfizer-BioNTech vaccine is approved for anyone over age 16, but the F.D.A.’s authorization for the booster includes only those over age 18.
The next step is for Dr. Rochelle Walensky, the director of the C.D.C., to make a formal recommendation. If she follows the guidance of the agency’s advisory committee, as is typically the case, the C.D.C. guidance may conflict with that of the F.D.A.
The number of Americans who will qualify includes only those who already received two doses of the Pfizer-BioNTech vaccine. The panel was not asked to judge whether people who received the Moderna and Johnson & Johnson vaccines should receive booster shots, which have not been authorized by the F.D.A.
Several experts nevertheless supported a mix-and-match strategy, and signaled that they would revisit the issue as new data emerge.
State health departments generally follow the recommendations of the C.D.C.’s Advisory Committee on Immunization Practices.
And anyone who wants a booster may simply be able to walk into a pharmacy and ask for one — many Americans already did so before the F.D.A.’s authorization, typically by finding a cooperative pharmacist or pretending to be unvaccinated.
The C.D.C. panel’s guidance followed weeks of internal disagreement and public debate among American health officials and advisers. In mid-August, President Biden announced plans for a booster rollout, but regulators significantly slowed the proposed timeline.
And public health experts criticized what they said were confusing public messages from the Biden administration, all the more notable because the F.D.A. does not have a permanent leader. Its acting commissioner, Janet Woodcock, said on Wednesday that the authorization would allow for booster doses “in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”
But some members of the C.D.C. panel said there was little evidence to suggest that vaccinated teachers, and even health care workers, are at risk of repeated exposure to the virus.
During a two-day meeting culminating on Thursday, the C.D.C.’s advisory panel wrestled with the public’s expectations for Covid vaccines, the safety of third doses and how a booster program would affect nursing home residents.
The advisers also grappled with the lack of clarity on the goal of the vaccines: Is it to prevent all infections, or only to forestall severe illness and hospitalization? Many suggested it should be the latter, and that thwarting all infections was a foolhardy goal.
Several members of the committee pointedly questioned why federal health agencies were focusing on booster shots for Pfizer recipients to begin with, given the higher risks facing the unvaccinated.
“We may move the needle a little bit by giving a booster dose to people,” said Dr. Helen Talbot, an associate professor of medicine at Vanderbilt University. But, she added, “the hospitals are full because people are not vaccinated.”
Pfizer scientists had argued to the committee that waning antibody levels in people who had received the shot indicated that their immunity was dropping.
And on Thursday, C.D.C. scientists presented models indicating that, if booster doses were to slightly increase people’s protection against hospitalization, the additional shots could prevent more than 2,000 hospitalizations for every million doses given.
But it is not at all clear how long any additional protection from a booster would last.
Some committee members doubted the wisdom of looking only at antibody levels to gauge immunity. The antibodies needed to prevent infection may naturally wane a few weeks to months after the injection, but the immune cells that prevent illness from progressing — but are harder to measure — remain stable many months after the second dose, according to data presented by one C.D.C. scientist.
Boosters can reduce infections in nursing home residents, who are among those at highest risk. Even so, cases in nursing homes will persist when community transmission is high, according to a modeling study presented at the meeting.
Scientists who presented data to the advisers noted that while a third dose would undoubtedly amp up antibody levels, it’s unclear how long those elevated levels would last, whether they translate to meaningful extra protection against severe disease, and whether they can significantly decrease transmission of the virus.
They also noted the paucity of safety data, especially among younger people.
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September 24, 2021 at 06:32AM
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C.D.C. Panel Recommends Pfizer Boosters for Many Americans, but Not Health Workers - The New York Times
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