FDA Grants Priority Review to Pfizer-BioNTech Vaccine; Full Approval Decision by January 2022

Quite to the contrary, 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 PDUFA Goal Date.

— Dr. Janet Woodcock (@DrWoodcockFDA) July 16, 2021

The US Food and Drug Administration (FDA) has agreed to a “priority review” of Pfizer-BioNTech’s COVID-19 vaccine for a full approval decision by January 2022.

According to FDA commissioner Dr. Janet Woodcock, action will likely come much sooner because regulators consider the review “among the highest priorities of the agency.”

A confidential FDA source told CNN that the agency will probably decide within the next two months. 

The FDA has not yet fully approved any of the three COVID-19 vaccines — Pfizer-BioNTech, Moderna and Johnson & Johnson — that it has authorized for emergency use in the US

Pfizer-BioNTech began submitting data to the FDA in May to support a Biologics License Application (BLA), which included the latest results from a clinical trial tracking participants 16 and older for six months after their second vaccine dose. 

The companies expect to seek full approval for use in people ages 12 to 15 once more data is available. The FDA expanded the vaccine’s emergency use authorization in May to include adolescents.

Moderna has also begun submitting data for full approval of its two-dose vaccine, and Johnson & Johnson is expected to begin the process soon.

Moderna has also been granted priority review of its application, which gives a six-month timeline for the approval process instead of the standard 10 months. 

The BLA would enable the companies to distribute and market the vaccine even after the official public health emergency ends. 

FDA approval could also help shape future vaccine mandates and prompt requirements from employers, schools and other institutions.

A poll in May found as many as one in four companies could mandate the vaccines once approved. There have also been reports that the military is planning a vaccination requirement once the shots get full approval. 

Public health experts believe such a requirement could help sway those who are skeptical of the vaccine to get their shot. 

US Surgeon General Dr. Vivek Murthy told The Washington Post on Friday, “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.” 

According to the US Centers for Disease Control and Prevention (CDC), more than 160 million people — 48.4% of the US population — are fully vaccinated as of Saturday. 

A June survey from the Kaiser Family Foundation found that 31% of unvaccinated adults said they would be more likely to get a vaccine if one of the shots currently authorized for emergency use got the full stamp of approval from the FDA.  

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Source: Equities News