However, the same committee rejected an initial proposal, put forward by Pfizer and endorsed by the administration of President Joe Biden, to fully approve the boosters for all people over 16 years of age.
The decisions were made after a one-day meeting filled with data presentations and, at times, a loaded debate that was convened by the Food and Drug Administration (FDA). Tens of millions of Americans will soon be eligible for a third vaccine.
“I think this should demonstrate to the public that the members of this committee are independent from the FDA, and that we do indeed bring our voices to the table,” said Archana Chatterjee, dean of the Chicago School of Medicine.
The panel, which included vaccinologists, infectious disease researchers, and epidemiologists, concluded that the benefit-risk balance differed for younger people, especially men at risk for myocarditis.
A clinical trial for the booster involved just over 300 people, who felt it was too small to be able to draw firm conclusions about safety.
The panel voted 16-2 against granting a third round of full approval.
Then a new motion was presented to them and they voted 18-0 in favor of granting emergency authorization for people over 65 and those at high risk. They agreed that this should be extended to healthcare workers and people at high risk of occupational exposure.
Now the issue goes to another committee, this time convened by the Centers for Disease Control and Prevention (CDC) September 22-23 to further define who is eligible and decide on implementation.
Pfizer will work with the FDA to address the committee’s questions as “we continue to believe in the benefits of a booster dose for a broader population,” Kathrin Jansen, the company’s head of vaccine research and development, said in a statement.
Even before the meeting, the Food and Drug Administration (FDA) had taken a note of caution.
In its information paper, the FDA stated, “Data indicates that Covid-19 vaccines currently licensed or licensed in the US still provide protection against severe Covid-19 illness and death.”
Meanwhile, two senior FDA officials jointly signed a point of view in The Lancet this week opposing the drivers for the general population, in what was seen as a reprimand to the White House for making a decision before consulting with their scientific agencies, effectively placing the cart before the horse. .
At the meeting, Pfizer officials cited studies that showed decreased immunity against infection several months after the first two doses.
“The proven safety and efficacy of a third dose supports the addition of a booster dose to the vaccination schedule,” said Donna Boyce, senior vice president of global regulatory affairs for Pfizer.
But a growing body of research in the US, including a dataset presented by Pfizer itself at Friday’s meeting, has shown that two doses continue to provide high protection against severe outcomes, albeit at slightly decreased levels for the elderly. .
Pfizer also presented data showing that boosters increase antibody levels against the Delta variant, but an FDA scientist responded that these laboratory studies could not be directly translated into efficacy estimates.
Sharon Alroy Preis, an official from the Israeli Ministry of Health, presented data from her country that ran a booster campaign after experiencing a delta wave, and has approved boosters for all people 12 years of age and older.
Jay Portnoy, a pediatrician at Children’s Mercy Hospital in Kansas City, said the Israeli experience should serve as a warning beacon and the United States should follow suit.
But the majority of the panel did not view the two countries as very similar. Because the US has a much lower overall vaccination rate, the unvaccinated are the main drivers of the spread, rather than advance cases among the vaccinated.