The Health 202: The FDA could boost vaccinations by fully approving Pfizer's vaccine.

There's one thing that could make an immediate impact on vaccine uptake: Granting full FDA approval to Pfizer's shot.

It's been eight weeks since Pfizer and BioNTech applied to the Food and Drug Administration for full approval of their coronavirus vaccine, but the agency has yet to act. Pressure is growing for the FDA to move faster to license the vaccine.

"Tens of millions of Americans will get vaccinated once this is approved," said Eric Topol, director and founder of the Scripps Research Translational Institute.

Topol argues that full approval will reduce vaccine hesitancy and make it easier for employers, universities and the military to mandate vaccines. The lack of authorization, he said, "is the singular thing holding us back as a country right now."

Ashish Jha, dean of the Brown University School of Public Health:

But the FDA has given little sign of when to expect full authorization.

The three coronavirus vaccines in use in the United States were approved under the FDA's emergency use authorization last winter.

The companies behind two of those products have since requested full authorization: Pfizer and BioNTech submitted data for full approval of their vaccine on May 7, while Moderna followed suit on June 1. Johnson & Johnson, which received emergency use authorization later than the other vaccine makers and has since faced troubles with its manufacturing operations, is further behind.

So far, the FDA has not given a timeline for when it plans to pursue full authorization. At a recent news briefing, Anthony S. Fauci, President Biden's chief medical adviser, refused to speculate.

We don't want to get ahead of the FDA. They have their process where they need to cross all the t's and dot all the i's," Fauci said.

Those pushing the FDA to move faster say full approval could be game-changing.

A Kaiser Family Foundation poll in May found that nearly a third of unvaccinated Americans said they would be more likely to get the shot once it was fully approved. That response dwarfs the portion of unvaccinated people who said they would be swayed by time off work or free incentives.

Other people may get the vaccine because they are required to do so. The U.S. Army has indicated that it will make coronavirus vaccines mandatory starting in September, if they have full FDA approval. And full approval would also make it easier for employers and schools to mandate vaccines.

The lack of full authorization has been a core part of the messaging and litigation strategy of anti-vaccine groups. And while a federal judge upheld at least one large Texas hospital's mandate for its employees, many employers are cautious about inviting litigation.

Dorit Rubinstein Reiss, a professor at the University of California Hastings College of the Law, argues that employers should be able to legally mandate vaccines that are under emergency use authorization, but she admits they'll have an easier time of it with full approval.

"The anti-vaccine movement has been working to scare people from covid-19 vaccinations long before the emergency use authorization. … They're not going to stop," Reiss said. "However, it will make litigation against mandates significantly harder because the [emergency use authorization] is one of the few things that hasn't been litigated before and that has some legal uncertainty behind it."

Calling the vaccines "experimental" has become a scare-tactic.

Anti-vaccine groups have seized on the emergency use authorization to portray the coronavirus vaccines as experimental, but experts say that's inaccurate.

While it's true that the emergency use designation can be used to authorize drugs or other products with a lower standard of evidence — some experts point to the brief approval of hydroxychloroquine under the Trump administration — that's not the case with the coronavirus vaccines.

The clinical trials for the coronavirus vaccines are larger than other historic vaccine trials used to support full FDA approval, according to Joseph Ross, a physician and expert in FDA approvals at the Yale School of Medicine.

While some centers of the FDA allowed for lower standards for emergency use in the early days of the pandemic, Ross said, the center in charge of vaccine approvals, known as the Center for Biologics Evaluation and Research (CBER), set a high standard.

"I think to our good fortune, the center on vaccines, CBER, said we can't misstep with the vaccines and set high authorization standards, almost what you need for a full approval," Ross said.

Since then, more than 300 million doses of mRNA vaccines have been distributed with great success.

"There's never been a vaccine in history that's had this scrutiny," Topol said.

But the process of approving a vaccine is not usually quick.

A study of novel vaccine approvals over the past decade by Ross and his colleagues at the Yale School of Medicine found the median FDA review period was 12 months.

In addition to reviewing clinical data, regulators also inspect and gather data about the facilities producing the vaccines.

"Seven weeks is not a lot of time," said Reiss, the University of California professor. "I expect they will try to move faster than the typical 12-month average, but I think we are still looking at months and not weeks."

Reiss said that in the long-run, it behooved the FDA to be "careful, thorough and conservative."

Critics say the FDA should move faster.

Topol argues that the May 7 filing from Pfizer was the culmination of six months of conversations, which should have given the agency time to get ahead on the momentous task of reviewing data for approval.

"This is a global crisis. We're starting to head into another phase that's not good," Topol said. "I think it's irresponsible that they haven't even made a public statement, giving us a timeline."

Washington Post, July 6, 2021 By Alexandra Ellerbeck with Paige Winfield Cunningham


July 8, 2021

Voices4America Post Script. Though calling the vaccines "experimental" is baloney and a scare-tactic, we all wait for a painfully slow FDA to give #FullApproval. It will affect about 1/3 of the unvaxxed. The FDA just moves slowly. Now that you have read all about it, share this so others will know.

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