FDA panel endorses COVID-19 booster shots for older Americans, rejects widespread use

A federal advisory panel on Friday unanimously voted to recommend the Food and Drug Administration (FDA) authorize a third booster dose of Pfizer and BioNTech’s coronavirus 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 that vote only occurred after the panel overwhelmingly voted against recommending the widespread use of boosters for everyone over the age of 16. The move represents a rebuke of the Biden administration and deals an unexpected blow to the president’s plan to administer booster doses to all Americans over 16 beginning Sept. 20. 

The targeted recommendation is much narrower than what the companies and top officials in the Biden administration had initially sought.

“The incremental benefit to the younger population has not been shown at all,” said panel member Michael Kurilla, ​a clinical director at the National Institutes of Health.

“We just can’t simply be in a position where we would just be vaccinating people every time we think there’s a problem.” 

The panel’s vote is not binding, so the FDA doesn’t have to accept the results. But if it doesn’t, it would likely raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.

Peter Marks, the agency’s top vaccine regulator, noted that the recommendation could be tweaked.

Should the FDA sign off on the recommendation, a Centers for Disease Control and Prevention (CDC) advisory panel will meet next week to decide more details about who specifically should qualify for the boosters, and when they’ll be administered. 

The FDA panel members did not vote to define who is considered high risk, but the category will likely include health care workers as well as people with pre-existing conditions like diabetes, heart disease and obesity.

Following the panel’s vote, the White House said it was ready to move forward.

“Today was an important step forward in providing better protection to Americans from COVID-19. We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week,” assistant press secretary Kevin Munoz said.

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.

People who received Moderna’s vaccine and the Johnson & Johnson vaccine will not be eligible until FDA gives those companies the green light. Moderna submitted booster data at the beginning of September, and Johnson & Johnson has not yet submitted evidence. 

In an unusual move last month, President Biden and top health officials, including Surgeon General Vivek Murthy, acting FDA Commissioner Janet Woodcock and CDC Director Rochelle Walensky, publicly announced a booster shot program would begin next week, well before the FDA and CDC examined the evidence.

While officials have been careful to say the booster program is contingent on the FDA and CDC giving the green light, they have been criticized by some public health experts for speaking as if the approval was a given.

The increasingly contentious issue of boosters has divided outside scientists as well as some inside the FDA.

Research in the U.S. indicates that immune response does wane over time, but the current COVID-19 vaccines still afford protection against severe COVID-19 disease and death. 

CDC scientist Sara Oliver presented data showing that while protection against milder infections has waned over time, protections against severe disease remained strong. Unpublished data from CDC through July showed people over age 75 were 88 percent protected against hospitalization. 

Panel members felt that level of protection was enough, and they disagreed with the importance of vaccinating to stop mild infections.

“It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data,” said Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

FDA’s Marks noted that many other vaccines are used to prevent mild infections. He also mentioned the importance of preventing the spread of the virus to vulnerable populations such as children who are currently too young to be vaccinated.

Updated at 7:08 p.m.