FDA panel says yes to COVID boosters in older Americans, plus those at risk of serious disease
A key Food and Drug Administration (FDA) advisory panel unanimously voted to recommend the FDA authorize a third booster dose of Pfizer and BioNTech’s COVID-19 vaccine for people over the age of 65 as well as for other groups of people who are at high risk for COVID-19.
But the vote only occurred after the panel overwhelmingly voted against recommending the widespread use of boosters for everyone over the age of 16.
The targeted recommendation is much narrower than what the companies and top officials in the Biden administration had initially sought.
In a statement following the meeting, Kathrin U. Jansen, the head of Pfizer’s vaccine research and development, said the company will work with FDA to address the issues raised by the committee, “as we continue to believe in the benefits of a booster dose for a broader population.”
The meeting lasted all day, and the differing viewpoints offered by panel members could be a sign of the confusion ahead.
Ultimately, advisory panel members said they were concerned about the lack of safety data, especially for those on the younger end of the age spectrum.
What’s next: The FDA panel members did not vote to define who is considered high risk, but the panel members indicated they think the category ought to include health care workers as well as people with pre-existing conditions like diabetes, heart disease and obesity.
Should the FDA sign off on the recommendation, a Centers for Disease Control and Prevention advisory panel will meet next week to decide more details about who specifically should qualify for the boosters, and when they’ll be administered.
People with severely weakened immune systems are already eligible for a third dose, though the broader booster recommendation will only apply to the vaccine from Pfizer-BioNTech.
Left unanswered: What about everyone else? The panel did not address that. More than 67 million people have received the Moderna vaccine, and 14.5 million people received Johnson & Johnson. They’re not eligible yet, because the committee was only looking at the evidence from Pfizer and BioNTech. Moderna only submitted its evidence earlier this month, while J&J has yet to submit data. The company touted results in August and said it was working with regulators, but there hasn’t been much more information.
Biden brushback? The fact that the panel voted down the original recommendation is an unexpected setback for the Biden administration. Experts said it shows the process was rushed; the administration decided boosters would be available starting Sept. 20, but the data just wasn’t ready yet.
The committee made clear it was independent from the FDA. The panel’s vote is not binding, so FDA doesn’t have to accept the results. But if the agency doesn’t, it would likely raise significant questions of political interference.
