After enduring weeks of criticism that it was dragging its heels, the Food and Drug Administration appears poised to fully approve Pfizer’s COVID-19 vaccine by early September, but public health experts are divided over whether the final endorsement will persuade reluctant Americans to get their shots.
Although President Biden said last week that he expected the FDA to approve the vaccine in early fall, the agency’s unofficial deadline is now Labor Day or sooner, multiple people familiar with the effort told The New York Times.
FDA officials gave no timetable Wednesday for completion of the review. But a spokeswoman said that because of the “urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach,” including providing additional personnel and resources to hasten the process.
That’s welcome news to public health experts. Several argued that Pfizer’s two-shot messenger RNA vaccine could have received final approval as early as May ― before the highly contagious Delta variant became the dominant strain in the United States ― removing a potential barrier for Americans who say they are wary about receiving a vaccine that has only received emergency use clearance.
“I can’t believe it’s taken this long,” said Dr. Monica Gandhi, an infectious diseases doctor at the University of California, San Francisco.
Pfizer was the first drug company to receive an emergency use authorization for a coronavirus vaccine from the FDA, on Dec. 11. The New York pharmaceutical giant then filed an application for full approval on May 7.
Two other drug makers, Cambridge-based Moderna and New Brunswick, N.J.-based Johnson & Johnson, followed Pfizer in receiving emergency use authorizations. Moderna filed for final approval of its vaccine on June 1 but is still submitting data. Johnson & Johnson has not yet applied.
Until the COVID-19 pandemic, the FDA had never cleared a new vaccine for emergency use.
Before granting full approval, however, the FDA will have to review much more clinical trial data than the agency did for emergency authorization. Regulators are also expected to consider real-world data on the safety and effectiveness of the vaccine, and will likely conduct inspections of manufacturing plants to ensure stringent quality controls are in place.
Dr. Walter A. Orenstein, a professor of medicine at Emory University and associate director of the Emory Vaccine Center, said approval of COVID-19 vaccines won’t sway “people who believe in conspiracy theories and don’t trust the government,” but it will persuade a significant number of hesitant Americans to get vaccinated.
Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, was more skeptical. Hotez has worked on vaccines for neglected tropical diseases afflicting the world’s poorest people and spent years debunking false claims, including that vaccines cause autism. (He wrote a 2018 book called “Vaccines Did Not Cause Rachel’s Autism: My Journey as a Vaccine Scientist, Pediatrician, and Autism Dad.)
Although he welcomes full approval of COVID-19 vaccines, he said a right-wing “disinformation empire” will roll out a dozen outlandish theories for why people shouldn’t get vaccinated, including unfounded allegations that the substances contains microchips, modify a person’s DNA, and are instruments of government control.
“It’s like playing a game of whack-a-mole,” Hotez said. Approving the vaccines “is the right thing to do, but as an approach to increasing vaccination rates, I don’t see it as a game changer.”
More than 165 million Americans have been fully vaccinated with one of the three vaccines granted emergency use authorization, according to the Centers for Disease Control and Prevention. But those authorizations are conditional and were given as part of an accelerated and streamlined approval process in a public health emergency. That’s become a talking point for many vaccine opponents who argue that the shots are experimental and potentially unsafe.
A recent poll by the Kaiser Family Foundation, which has been tracking public sentiment during the pandemic, found that three of every 10 unvaccinated people said that they would be more likely to get a shot with a fully approved vaccine. Importantly, of the subset of unvaccinated who described themselves as in “wait and see” mode, 49 percent told Kaiser that full FDA approval would make it more likely they would finally get an inoculation.
Gandhi, of UCSF, said that although some Americans mistakenly believe the vaccines already have FDA approval, others are aware that they have only been cleared for emergency use. They know that they have to sign a consent form to get a shot, which, she said, would not be the case once the vaccines are fully approved.
“That can be a deterrent,” she said. “Psychologically, it makes it feel like it’s experimental.”
Full approval would do more than remove that impediment, she added. It would give governments and businesses greater legal authority to insist that people be vaccinated if they want to return to work in person or participate in other activities, including eating in restaurants or visiting health clubs.
New York City Mayor Bill de Blasio announced Tuesday that his city will become the first in the country to require proof of at least one dose of a coronavirus vaccine for a variety of activities, to put pressure on people to get vaccinated.
Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in San Diego, expects to see more mandates across the country, especially after drug regulators give vaccines full approval.
Topol, who has served on multiple FDA advisory committees, found it unfathomable how slowly the agency has moved on licensing vaccines compared with the FDA’s approval in June of Biogen’s drug for Alzheimer’s, a contrast he explored in a recent essay published in The Times.
The FDA, he noted, approved the Cambridge biotech’s Alzheimer’s medication, Aduhelm, through an accelerated process despite limited evidence that it worked in two late-stage trials that enrolled about 3,200 volunteers. In contrast, more than 347 million doses of the three coronavirus vaccines have been administered in the United States, and they have proven overwhelmingly safe and effective. Yet the FDA has yet to act on Pfizer’s filing for approval.
“There’s no bigger health crisis in America than this, obviously,” he said. “Meanwhile, [regulators] are futzing around with the Alzheimer’s drug.”
Jonathan Saltzman can be reached at firstname.lastname@example.org.