The Food and Drug Administration pumped the brakes on Pfizer’s push to provide COVID-19 boosters-for-all two months ago, but the drugmaker has the wind at its back as it tries again.
This time, Pfizer is armed with new efficacy data and support from a Biden administration that wants to fully protect Americans from a potential virus spike this winter.
Mr. Biden has been pushing for booster shots since August, citing studies in Israel that showed waning immunity over time could lead to more infections. But an FDA advisory committee reined in Pfizer’s application at a September meeting, saying only the elderly and medically frail need them, not everyone 16 and older.
The drugmaker’s new application to boost those 18 and above is a second bite at the apple as millions of people line up for a booster program that was expanded in recent weeks. While some experts remain leery of the need to boost everyone, approval of extra shots could arrive well before the winter holidays.
“For those who are eligible for a boost now we would absolutely encourage that they get boosted,” Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Wednesday, one day after Pfizer submitted its request. “As you likely know, FDA is currently looking at the data for expanding boosters to all populations.”
Pfizer on Tuesday presented new data on safety and efficacy from 10,000 participants in the U.S., Brazil and South Africa with a median age of 53 who completed a two-dose series with the Pfizer vaccine. It found those who received a booster were far less likely to get sick.
SEE ALSO: Germany recommends Pfizer over Moderna for those younger than 30
“During the study period, there were five cases of COVID-19 in the booster group, and 109 cases in the non-boosted group,” the company said in a press release.
William Schaffner, an infectious diseases specialist at Vanderbilt University, said there isn’t any doubt that scientists and the leaders at Pfizer believe a booster should be part of the routine vaccination series for all adults.
“I think they believe that sincerely, but not everyone agrees with that,” he said. “I think the Pfizer folks are working in the slipstream of what I might call Washington permissiveness and encouragement.”
Dr. Paul Offit, a member of the FDA advisory committee, told The Washington Times that while the booster shot would create the antibody response the company says it does, the shots remain effective at preventing moderate to severely symptomatic disease and hospitalization for healthy, non-elderly adults.
For that reason, he would like to see the FDA schedule a meeting of the advisory panel for a robust, public discussion about whether the benefits for younger adults outweigh a rare side effect known as myocarditis, an inflammation of the heart muscle.
The FDA told The Washington Times it will determine whether to hold a meeting of the advisory panel, known as the Vaccines and Related Biological Products Advisory Committee, after its initial review of Pfizer’s request.
“While the agency cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible using its thorough and science-based approach,” said agency spokeswoman Alison Hunt. “As we have with all COVID-19 vaccines, we intend to be as transparent as possible with this process.”
Lawrence Gostin, a global health law professor at Georgetown University, said it would be in the FDA’s best interest to engage the panel.
“There are undoubtedly political dimensions and the president has long promised population-wide boosters. That is why it is important for the FDA to stick with the science and resist any political influence,” he said.
The New York Times reported that the agency is expected to grant the request by Thanksgiving, meaning it would go into effect before the Christmas travel period.
Coronavirus cases are down 50% from a delta-wave peak in September, though they are starting to plateau on the cusp of colder months. Hospitalizations also are down 12% from two weeks ago.
Federal officials say they want to be ahead of the curve in case a winter surge and waning immunity from long-ago vaccinations begin to morph into a problem.
“Biden is absolutely worried about the winter so I think a key weapon for him is to re-up on immunity and the supply to do so is there,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.
He said data from Israel, which got an early start on vaccination and collects centralized data, supports an extension at least to those 50 or older but the “market is huge”
“Pfizer knows this and that I believe is part of the push to over-18s,” he said.
The U.S. is allowing vaccinated persons to mix and match their booster shots, so 181 million vaccinated Americans would become eligible for a Pfizer booster under the plan.
As it stands, 13% of fully vaccinated persons have opted to get a booster dose of the vaccine.
Persons who are older than 65, adults with underlying conditions and people in high-risk jobs who received an initial series from Pfizer or Moderna may seek out a booster from any of the three vaccines if they are at least six months out from their second dose.
Any American adult who received a Johnson & Johnson vaccine at least two months ago may seek another dose of any vaccine, amid concerns the 15 million recipients need another dose to match the efficacy demonstrated by the other vaccines.
Dr. Walensky said getting holdouts to come forward for their initial vaccine series is the most critical aspect of the pandemic fight. Yet the administration is promoting boosters alongside first-time vaccination.
Earlier this month, Dr. Anthony Fauci signaled it was only a matter of time before the booster program was expanded.
“People who have a primary vaccination are still really quite protected against severe disease and hospitalization,” Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said at a Nov. 1 briefing. “But I think, in due time, we will have equity so that people will be able to get vaccine in a booster situation as needed.”
The number of people receiving a booster shot each day soared after the FDA expanded eligibility in late October. About 800,000 people, on average, are coming forward for a booster each day in November, according to White House COVID-19 Coordinator Jeff Zients.
That far outstrips the number of people initiating vaccination with a first dose, which is averaging around 300,00 per day over the past seven days.
U.S. officials and experts widely agree that getting unvaccinated people some level of protection is the most important thing they can do to control the virus, yet the booster debate may be hardening resistance among holdouts.
A September survey by the Kaiser Family Foundation found that most unvaccinated adults “see the booster discussion as a sign that the vaccines are not working as well as promised while most vaccinated adults see it as a sign that scientists are continuing to find ways to make vaccines more effective.”
For more information, visit The Washington Times COVID-19 resource page.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
Please read our comment policy before commenting.