FDA, Under Growing Pressure, Moves To Give Formal Approval To Covid Vaccines

The Food and Drug Administration is under tremendous pressure to expedite the process of granting Covid vaccines full approval, starting with Pfizer's.

The vaccines were approved for distribution under an emergency use authorization because Covid is a public health emergency. Experts believe full authorization will help convince the unvaccinated to overcome their fears and will give private and public sector organizations a stronger legal basis for mandatory vaccination orders. JL

Nicholas Florko reports in Stat:

With Covid-19 still raging, and its spread now fueled by the Delta variant, lawmakers and health experts urged the FDA to expedite full approval of Pfizer’s vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and give businesses and other entities a stronger legal foundation to impose vaccine mandates. Pfizer’s vaccine is under an emergency use authorization, which allows the company to sell the vaccine as long as Covid-19 is a public health emergency. “My expectation is that in the beginning of the school year, at the end of August, beginning of September they’ll get a final approval”

WASHINGTON — Under heavy pressure, the Food and Drug Administration center that reviews vaccines is planning to deprioritize some of its existing work, like meetings with drug sponsors and plant inspections, in an effort to accelerate its review of Pfizer’s application for the formal approval of its Covid-19 vaccine, a senior agency official told STAT.

Pfizer’s vaccine is currently cleared under a so-called emergency use authorization, which allows the company to sell the vaccine for as long as Covid-19 is considered a public health emergency.

But with Covid-19 still raging, and its spread now fueled by the Delta variant, lawmakers and prominent health experts have urged the FDA to expedite full approval of Pfizer’s vaccine, saying it would be a powerful tool in convincing the unvaccinated to get their shots and in giving businesses and other entities a stronger legal foundation to impose vaccine mandates.

The process requires FDA staff to review millions of pages of complex data, conduct plant inspections, and negotiate with Pfizer over issues including the terms of the FDA’s approved label and the company’s postmarketing responsibilities. Now, the senior agency official said, the agency will initiate a “sprint.”

Under the FDA’s new plan, the director of FDA’s biologics center, Peter Marks, will largely oversee review of the Pfizer application, taking over for Marion Gruber, a 32-year veteran of the FDA who currently heads the office of vaccine research and review within the larger biologics center, according to a second FDA source. A third source familiar with the plan, who like the others spoke on condition of anonymity, said Marks was heavily involved in the review, but did not comment on whether he was formally replacing Gruber in the agency’s chain of command.

The reprioritization of other work at the agency’s biologics center underscores the tremendous political pressure the agency is under to finish the Pfizer review as quickly as possible.

Eric Topol, the director and founder of Scripps Research Translational Institute, who has been among those critical of the agency’s perceived slowness in finishing the review, said he was “thrilled” about plans to expedite it. But he also said the FDA should have accelerated the process much earlier.

“We knew about Delta months ago ..and that’s when we should have pulled out all the stops,” he added.

Luciana Borio, a former FDA acting chief scientist, also said the sprint made sense but that it would likely mean other projects will have to be deprioritized.

“There should be no illusion that this comes at zero cost,” she said.

The FDA has publicly insisted that rushing the approval of the application could “undermine the FDA’s statutory responsibilities, affect public trust in the agency, and do little to help combat vaccine hesitancy.”

When asked about the sprint, FDA spokesperson Michael Felberbaum said in a statement: “We have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.”

The statement did not specifically mention the FDA putting off inspections or meetings with FDA sponsors.

It’s not clear how significantly the reprioritization of work will impact companies with other products before FDA’s biologics center, which reviews everything from vaccines and stem cells to gene therapies. The senior FDA official told STAT that the agency will strive not to miss promised milestones with other sponsors, but that some might hear from the agency that certain meetings and inspections will be pushed off by weeks or months. .

Janet Woodcock, the acting FDA commissioner, held a meeting with all FDA staff reviewing the Pfizer application on Monday, two sources confirmed to STAT.

Felberbaum, the agency spokesperson, said that Woodcock “has reiterated her appreciation for the diligence and integrity to this process and offered all agency resources to the team to make this happen.”

A typical review of an application like Pfizer’s takes 10 months. The agency granted Pfizer a “priority review” for its vaccine earlier this month, which signifies that staff will strive to finish the review of the application within six months. At the same time, he FDA has said it does not expect the process to take that long — a view echoed even by President Biden.

“My expectation …  is that sometime, maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval” Biden said last week when asked when the FDA would formally approve the Covid-19 vaccines, including the one developed by Pfizer and its partner BioNTech.

Jesse Goodman, who led the FDA’s biologics center from 2003 to 2009, said that the August-September time frame is “possible … if all goes smoothly.” He said the idea of a sprint is “reasonable,” so long the biologics center follows the normal chain of command for reviewing these applications.