A panel of top US medical experts advising the government has voted to allow a booster dose of the Pfizer coronavirus vaccine for everyone 65 years of age and older, as well as for people at risk of developing severe symptoms.
The same committee rejected an initial proposal, made by Pfizer and supported by the administration of US President Joe Biden, to provide a booster dose for everyone aged 16 and over.
The committee's decision came after a full-day meeting that witnessed the presentation of data, as well as a charged discussion by the Food and Drug Administration.
Tens of millions of Americans will soon be eligible for a third dose.
Archana Chatterjee, dean of Chicago Medical College, said: “I think this should demonstrate to the public that the members of this committee are independent of the FDA, and that we are in fact bringing our voices to the negotiating table.
The panel, which included vaccine specialists, infectious disease researchers and epidemiologists, concluded that the balance between benefits and risks differs for young people, especially males at risk of developing myocarditis.
A booster-dose clinical trial of just over 300 people, which the panel deemed too small to draw firm conclusions about safety.
The committee voted 16 to 2, against granting the third dose full approval.
Then he presented them with a new proposal, and they voted 18 to none to grant emergency authorization of a third dose for people over 65 and people at high risk. They agreed that this would include health care workers.
The matter turns to another panel, this time called by the Centers for Disease Control and Prevention from Sept. 22-23 to further determine who is eligible for the third dose and decide whether to begin implementation.
Even before the meeting, the Food and Drug Administration had issued a cautious note, stating, "Data indicate that COVID-19 vaccines currently licensed or authorized in the United States still provide protection from severe corona and death from it."
Meanwhile, two senior Food and Drug Administration officials co-signed a view in The Lancet this week opposing booster to the general population, in what was seen as a rebuke to the White House for making a decision before consulting its scientific agencies.
At the meeting, Pfizer officials cited studies showing reduced immunity to infection several months after the first two doses.
However, a growing body of American research, including a data set presented by Pfizer itself at Friday's meeting, showed that two doses still give high protection against severe Corona, albeit at slightly diminished levels for the elderly.
Pfizer also provided data showing that the booster dose increased levels of antibodies against the delta variant, but an FDA scientist responded that these lab studies could not translate directly into efficacy estimates.
Sharon Aroy Press, an official in the Israeli Ministry of Health, provided data from her country, which campaigned for the booster dose after it was exposed to a delta wave and agreed to provide a third dose to everyone aged 12 years and over.
Jay Portnoy, a physician at Children's Hospital in Kansas City, said the Israeli experience should serve as a warning beacon and that the United States should follow suit.
But most members of the committee did not see the two countries as close. Because the overall vaccination rate in the United States is much lower than in Israel, the unvaccinated are the main driver of spread, not penetration among vaccinators.
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