US FDA to review full approval of Pfizer/BioNTech’s COVID-19 vaccine by January

The US FDA will review Pfizer and German partner BioNTech SE’s application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said.

The target action date does not mean the approval will not happen before January, the US Food and Drug Administration’s Acting Commissioner Janet Woodcock said on Twitter.

“Quite to the contrary, the review of this BLA (biologics license application) 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.”

The vaccine is among the three being used in the US under the FDA’s emergency use authorisation, alongside shots from Johnson & Johnson and Moderna Inc.

If approved, it would be the first shot to get the agency’s full approval based on longer-term data on safety and effectiveness, potentially helping ease vaccine hesitancy as the country witnesses new outbreaks in some parts, mainly due to the highly infectious Delta coronavirus variant.

Over 85 million Americans have been fully vaccinated with Pfizer’s vaccine, according to latest government data.

Pfizer/BioNTech finished submitting their application for a full US approval in May and the agency will review the data under its “priority review” pathway.

The FDA in May expanded the emergency use of the two-shot vaccine to children 12 through 15 years of age.

The companies said they intend to submit an application to support approval of the vaccine in this age group once the required data is available six months after the second dose.

Moderna filed for full US approval of its COVID-19 vaccine for adults early in June.

(Edits by EP News Bureau)