FDA grants priority review to Pfizer/BioNTech Covid-19 vaccine; agency official says approval decision expected within two months

By Jamie Gumbrecht, CNN

Pfizer and BioNTech said Friday that the US Food and Drug Administration has granted priority review designation to their application for full approval of their Covid-19 vaccine, and an FDA official said the decision will come “soon”.

The FDA official told CNN on Friday that a decision on full approval is likely to come within two months. The agency considers this matter a priority, said the official, who asked not to be named because they were not authorized to speak publicly on the matter.

Pfizer and BioNTech began the application for full approval of their Covid-19 vaccine — called a Biologics License Application — in May, and have completed the submission. The companies are seeking approval for the two-dose series for people age 16 and older, and expects to apply for approval for people ages 12 to 15 when the data are available. Moderna has also begun submitting data for approval of its two-dose coronavirus vaccine, and Johnson & Johnson is expected to seek FDA approval.

While the FDA must make its decision by January, it’s likely to come much sooner, acting FDA commissioner Dr. Janet Woodcock said. “…the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the … Goal Date,” Woodcock tweeted.

All three vaccines currently have emergency use authorization from the FDA.

In a letter to the New York Times this month, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, wrote that the review of applications for full approval of the Covid-19 vaccines is “one of the highest priorities” at the FDA, but it requires the evaluation of extensive manufacturing and clinical information.

“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” Marks wrote.

He noted that all three Covid-19 vaccines available in the United States have met the standard for emergency use authorization; Pfizer’s vaccine is authorized for use in people as young as 12.

“If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now,” Marks wrote.

Vaccine makers originally applied for emergency use authorization because the process takes less time than what would be required for full approval, but the safety and efficacy of the shots was tested in large trials and has since been confirmed by millions of doses administered since the vaccine rollout began late last year.

However, full approval could have an impact on vaccine mandates — several schools and business have suggested they would consider mandating Covid-19 vaccines once they are approved. It may also help sway skeptics hesitant to get the vaccines now.

A Kaiser Family Foundation survey of US adults released this week found that among the one-third of adults surveyed who are not yet vaccinated, 16% said the vaccine was too new, too unknown or not tested enough.

US Surgeon General Dr. Vivek Murthy said Friday that approval may encourage some to get vaccinated, but the vaccines have already been administered to millions around the world.

According to data from the US Centers for Disease Control and Prevention, more than 160 million people — 48.3% of the US population — are fully vaccinated against Covid-19.

“For some people the FDA approval process may make a difference, but I do think that we have a fair amount of experience right now, a tremendous amount of experience, that tells us that, again, the benefits of this vaccine far outweigh any risks,” Murthy said during a Washington Post event.

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CNN’s Maggie Fox and Virginia Langmaid contributed to this report.