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FDA vows ‘all hands on deck’ effort to get Pfizer coronavirus vaccine full approval as quickly as possible

As covid-19 cases rise, agency plans “sprint” to expedite approval and counter vaccine hesitancy

Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, testifies before a Senate committee on the pandemic in May. (Jim Lo Scalzo/EPA-EFE)

With coronavirus cases surging, the Food and Drug Administration’s top vaccine official said Friday the agency is redeploying staff and adding computer and other technical resources to accelerate an effort to grant the Pfizer coronavirus vaccine full approval as rapidly as possible.

“We have rolled out an all hands on deck” strategy to identify ways to expedite approval of the vaccine, which is currently being administered under the FDA’s emergency use authority, said Peter Marks, director of the Center for Biologics Evaluation and Research, in an interview.

He said the center — which, in addition to overseeing vaccines, regulates biologics, stem cells and gene therapies — is “thoughtfully reprioritizing” its work to focus on the vaccine as much as possible. Pfizer received emergency authorization for its two-shot vaccine in December and applied to the FDA for full approval May 7.

Moderna, whose vaccine also is being administered under emergency authorization, filed for full FDA approval June 1. Typically, it takes the agency at least several months to grant a full approval for a vaccine.

Marks would not speculate on when the FDA might grant full approval, but some agency officials have suggested it could be a matter of weeks, not months.

The move comes as the agency faces mounting pressure from lawmakers and some public health experts to fully approve a vaccine that has already been administered to millions of people in the United States, and more worldwide, without major problems.

Those pushing for quick approval say it could encourage vaccinations among people who have qualms about receiving what is still officially an experimental vaccine. They say it also could make governments, employers and other institutions more comfortable in mandating vaccinations.

“This will remove one more layer for the vaccine-hesitant,” Marks said. “If all this does is get five to 10 million more people vaccinations down south, that will save lives.”

The Kaiser Family Foundation, which is tracking sentiment toward the shots, reported in June that among unvaccinated adults who are aware that the vaccines are available under emergency use authorization, 32 percent said they would be more likely to get vaccinated if one of the vaccines were granted full approval by the FDA.

Stat, a news site that covers health and medical news, first reported the FDA’s reprioritization.

The need for a fully approved product is becoming more urgent as the start of the academic year approaches. Some governments and universities are interested in requiring vaccinations but are holding off until the FDA grants full approval to the vaccine.

The stepped-up effort is “essentially a sprint” using a team that focuses on one task at a time, rather than on multiple tasks, as FDA staff typically do, Marks said, adding that the agency would stick to its high standards for safety and efficacy.

Marks said the center would try to minimize delays that might affect other biologic products, because of missed meetings or slower action on applications — but couldn’t guarantee it.

“We are risk managers, and this is a matter of maximizing the potential benefit of getting the vaccine out,” he said.

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Coronavirus: What you need to know

Vaccines: The CDC recommends that everyone age 5 and older get an updated covid booster shot. New federal data shows adults who received the updated shots cut their risk of being hospitalized with covid-19 by 50 percent. Here’s guidance on when you should get the omicron booster and how vaccine efficacy could be affected by your prior infections.

New covid variant: The XBB.1.5 variant is a highly transmissible descendant of omicron that is now estimated to cause about half of new infections in the country. We answered some frequently asked questions about the bivalent booster shots.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. In the U.S., pandemic trends have shifted and now White people are more likely to die from covid than Black people. Nearly nine out of 10 covid deaths are people over the age 65.

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