A Food and Drug Administration advisory panel overwhelmingly voted Friday against giving Pfizer-BioNTech's Covid-19 booster shots to most people on Friday, agreeing only to distribute them to people ages 65 and up as well as those at high risk of severe illness.
The unanimous recommendation of boosters for a limited group of Americans was the second vote called by the Vaccine and Related Biological Products Advisory Committee, or VRBPAC, during its meeting Friday.
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The committee of outside experts was first asked whether a third shot of Pfizer's vaccine would be safe and effective for everyone ages 16 and older. Members overwhelmingly voted against that recommendation, citing concerns about the level of evidence showing the boosters are safe for younger people.
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Such feedback led to further debate among the committee members about specific age groups or populations that may be most appropriate for a third dose of vaccine. The panel subsequently narrowed the recommendation to those over age 65 and anyone at higher risk for severe illness.
People at high-risk of exposure at work, such as health care workers and teachers, will likely also be eligible for a booster dose.
The panel's recommendation will now go to the FDA, which is not required to follow VRBPAC's vote, but usually does. The FDA will decide whether to issue an emergency use authorization for the booster doses.
Though three Covid vaccines are in use, Friday’s vote focused on the Pfizer vaccine only, and would only apply to those who originally received the Pfizer shots. It does not apply to people who have received the Moderna or Johnson & Johnson vaccines.
The panel's ultimate recommendation was a measured response and "appropriate based on the data that was provided," said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting Centers for Disease Control and Prevention director.
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Still, the decision could put the FDA at odds with Biden administration officials who have been pushing to begin giving out booster shots to the general population starting the week of Sept. 20, essentially starting the countdown for the FDA and the CDC to act.
The booster question will now go to a group of advisers to the CDC, which will take up the issue in a two-day meeting next week.
Members of the FDA advisory committee struck a skeptical tone during the meeting Friday, questioning Pfizer’s conclusions that immunity is waning to the point that vaccinated people of all ages need an additional dose to protect against hospitalization and death six months after they’ve received their second dose.
Representatives from Pfizer said the need for a booster is based on data from Israel, which showed that severe cases increased tenfold from July to August, despite the fact that 60 percent of the population there was fully vaccinated.
But data from the United States, presented by the CDC, found the vaccines continued to provide high protection against severe disease, hospitalization and death.
Dr. Sara Oliver, an epidemic intelligence service officer at the CDC, noted that Israel and the U.S have different definitions for what’s considered severe disease. In Israel, she said, it is defined as lower oxygen levels and an elevated respiratory rate. In the U.S., severe disease refers to hospitalization or death.
The two countries also vary differently in population, pandemic and acceptance of vaccines. “You really have a very different situation in Israel than what we are facing here in the US at this point in time,” said Dr. Archana Chatterjee, an expert in pediatric infectious diseases at Rosalind Franklin University in Chicago.
The FDA advisory committee also raised questions about the safety of an additional dose, particularly in regard to the risk of myocarditis, a rare side effect that’s been seen primarily in males younger than 30.
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Israeli researchers reported Friday that among 2.8 million people who had been given a third dose, only one case of myocarditis had been reported. However, it’s only been two weeks since younger adults have been given a booster in Israel, and may not reflect the full scope of cases.
“I have a serious concern about myocarditis and young people,” Dr. James Hildreth, CEO of Meharry Medical College in Nashville, Tennessee, and a member of the advisory committee. “The booster shots induce a very strong response that is going to amplify the risk for myocarditis in those individuals.”
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Surgeon General Vivek Murthy said earlier Friday during a White House Covid task force briefing that the booster plan was always contingent upon the two agencies’ decision.
“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” he said. “We will follow that evaluation and their recommendations, we will make sure our final plan reflects it.”
Pfizer’s vaccine, sold under the brand name Comirnaty, received full FDA approval for ages 16 and older in August. This means doctors have the freedom to administer a third dose to patients they deem necessary for the shot; however physicians — and especially retail pharmacies and public health departments where the majority of Covid vaccines are administered — are sure to pay close attention to the outcome of Friday’s meeting.
The FDA previously OK’d an additional shot for people with compromised immune systems, who did not react strongly enough to the initial doses of the vaccines.
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