WASHINGTON - An advisory panel for the U.S. Food and Drug Administration on Friday voted to reject a plan to offer a booster dose of Pfizer-BioNTech’s COVID-19 vaccine for Americans saying more data is needed to determine if boosters are safe and effective.
The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-12, with members expressing frustration that Pfizer had provided little data on the safety of extra doses. Many also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.
However, the panel did vote to endorse COVID-19 booster shots only for Americans 65 and over or at high risk for severe disease.
During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.
"I don’t think a booster dose is going to significantly contribute to controlling the pandemic," said Dr. Cody Meissner of Tufts University. "And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses."
Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: "At this moment it is clear that the unvaccinated are driving transmission in the United States."
Panel members also complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.
The U.S. has already approved an extra dose of both the Pfizer or Moderna vaccines to people who are immunocompromised, or those with severely weakened immune systems.
The need for boosters and who should get them has been a subject of debate in recent days among scientists inside and outside the government, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine supply for their first.
The FDA is also not bound to follow the advice of its independent panel. But if the agency overrules its own experts, that could stoke public confusion as President Joe Biden and his top health advisers have trumpeted a booster campaign they hoped to begin next week.
U.S. health officials are urgently looking to shore up Americans’ protection against the virus amid the highly contagious delta variant, which has fueled U.S. COVID-19 cases and deaths to levels not seen since last winter.
If the FDA decides the extra shot is safe and raises immunity levels, then the U.S. Centers for Disease Control and Prevention will have to decide who should get another dose. The CDC has scheduled a meeting of its own advisers for next week and has signaled it is considering a booster for certain people — such as older adults, nursing home residents and front-line health workers — rather than the general population.
Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters. It’s not clear how soon that could come.
FILE - A nurse prepares to administer a Pfizer COVID-19 booster shot at UCI Medical Center in Orange, California, on Thursday, Aug. 19, 2021. (Photo by Jeff Gritchen/MediaNews Group/Orange County Register via Getty Images)
In opening remarks to the advisory panel on Friday morning, Dr. Peter Marks — the FDA’s top vaccine regulator — acknowledged the intense disagreements.
"We know there may be differing opinions in interpreting the data," Marks said. "We strongly encourage all the different viewpoints to be voiced and discussed regarding the data, which is complex and evolving."
Israel already is offering boosters to its citizens, and Britain this week announced plans to start giving them to people over 50 and certain other vulnerable groups once they are six months past their second dose.
In the first presentation of the day to the panel, British researcher Jonathan Sterne laid out the numerous problems with ongoing studies in showing exactly how effective vaccines are at different times in different countries.
"We should be very cautious of the apparent short-term benefits of vaccination," he said.
Israeli health officials presented data from their experience offering extra doses to nearly 3 million adults since late July. The government launched that effort after signs that the Pfizer vaccine's protection fell from 97% early this year to 85% by July among the first people vaccinated.
Sharon Alroy-Preis of Israel’s Ministry of Health told the panel that the booster dose improves protection tenfold against infection in people 60 and older.
"It’s like a fresh vaccine," bringing protection back to original levels and helping Israel "dampen severe cases in the fourth wave," she said.
Pfizer was expected to present data suggesting immunity from its vaccine wanes. A Pfizer study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose but had dropped to 84% by around six months.
On Wednesday, the FDA posted much of the evidence that the panel is considering and struck a decidedly neutral tone on the rationale for boosters. The agency’s reviewers have suggested they would mainly look to research on how the vaccines are working among Americans, saying that "may most accurately represent vaccine effectiveness in the U.S. population."
Overall, the data show that the Pfizer and other U.S.-authorized COVID-19 vaccines "still afford protection against severe COVID-19 disease and death in the United States," the agency said, summarizing the evidence.
Dr. Anna Durbin of Johns Hopkins School of Public Health said it’s important to understand the FDA’s decision simply is whether an extra dose is safe and does what it promises — to raise immunity levels.
The broader issue: "What really is going to control the delta variant is vaccinating the unvaccinated, not boosters," Durbin said.
To date, 63.5% of Americans who are eligible for the shots are fully vaccinated, according to CDC data — meaning more than one-third of the eligible population still isn’t protected.
For the average person, the CDC says real-world data show protection against severe illness, hospitalizations and deaths is holding strong. But in one recent study, protection against infection slipped as the delta variant hit: It was 91% in the spring but 78% in June and July. The CDC also has seen a hint that for people 75 and older, protection against hospitalizations slightly declined in the summer.
Moderna also has asked FDA to allow a booster dose of its vaccine, and on Wednesday posted its own study of waning immunity.
President Joe Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots a month ago, targeting the week of Sept. 20 as a start date. They said boosters would be dispensed eight months after the second dose of the Pfizer and Moderna vaccines.
But that was before FDA staff scientists had completed their own assessments of the data. Some experts questioned whether Biden was breaking his own pledge to "follow the science" on COVID-19 by getting out ahead of government scientists.
Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said continuing studies show the shots are working well despite the delta variant.
While the U.S. has already approved booster shots for certain people with weakened immune systems, such as cancer patients and transplant recipients, some healthy Americans have also managed to get boosters. In some cases, they have simply shown up and asked for a shot, and health systems already are offering extra doses to high-risk people.
The U.S. booster plan has also raised ethical concerns about the fate of people in impoverished parts of the world. But the administration has argued that the plan is not an us-or-them choice, noting that the U.S. is supplying large quantities of vaccine to the rest of the globe.
The Associated Press contributed to this report. It was reported from Cincinnati.