Health experts welcome full approval of Pfizer COVID-19 vaccine in coming weeks – The Boston Globe

Thats welcome news to public health experts. Several argued that Pfizers 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 cant believe its 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 wont sway people who believe in conspiracy theories and dont 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 worlds poorest people and spent years debunking false claims, including that vaccines cause autism. (He wrote a 2018 book called Vaccines Did Not Cause Rachels 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 shouldnt get vaccinated, including unfounded allegations that the substances contains microchips, modify a persons DNA, and are instruments of government control.

Its 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 dont 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. Thats 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 its 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 FDAs approval in June of Biogens drug for Alzheimers, a contrast he explored in a recent essay published in The Times.

The FDA, he noted, approved the Cambridge biotechs Alzheimers 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 Pfizers filing for approval.

Theres no bigger health crisis in America than this, obviously, he said. Meanwhile, [regulators] are futzing around with the Alzheimers drug.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.

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Health experts welcome full approval of Pfizer COVID-19 vaccine in coming weeks - The Boston Globe