The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Comirnaty, Pfizer’s and BioNTech’s COVID-19 vaccine, in individuals 16 years of age and older, making it the first COVID-19 vaccine to be granted full licensure by the FDA. The vaccine had previously been authorized for emergency use. The companies also initiated a supplemental biologics license application (sBLA) to the FDA for the approval of a booster (third) dose of Comirnaty in individuals 16 years of age and older.

The vaccine continues to be available under emergency use authorization (EUA) in the US for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. The vaccine first received an EUA in individuals 16 years of age and older in December 2020, and the authorization was expanded to include those 12 through 15 years of age in May 2021.

For full FDA approval, Pfizer and BioNTech submitted a data package that included longer-term follow-up data from a Phase III trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted priority review in July 2021.

Filing for a booster dose and other updates

The companies also report that they intend to complete submission to the FDA of a sBLA for a booster (third shot) of their COVID-19 vaccine by the end of this week (as reported on August 26, 2021). They also plan to file data with the European Medicines Agency and other regulatory authorities globally in the coming weeks (as reported on August 26, 2021).

Separately, the FDA has updated the Pfizer/BioNTech EUA to support the extension of shelf-life of their COVID-19 vaccine stored at -90 degrees to -60 degrees Celsius from six months to nine months. The FDA says this extension is also applicable to batches that might have expired prior to the EUA amendment, provided the product was stored at the same temperatures.

Source: Pfizer (FDA approval), Pfizer (third dose), BioNTech (FDA approval), BioNTech (third dose), the US Food and Drug Administration (approval) and the US Food and Drug Administration (EUA extension)