Pfizer, BioNTech's COVID-19 vaccine on brink of full FDA approval

According to people familiar with the matter, the FDA is expected to grant full approval to Pfizer and BioNTech's COVID-19 vaccine BNT162b2 as soon as Monday, The New York Times reported. The sources suggested that the agency was aiming to complete the process by August 20, but was still working through a large amount of paperwork, as well as continuing negotiations with the companies.

BNT162b2 first received an emergency-use authorisation (EUA) last December for people 16 and up, with the EUA expanded more recently to include preventing COVID-19 in adolescents 12 through 15 years of age. Meanwhile, in July, the FDA granted priority review to Pfizer and BioNTech's application seeking full approval of the mRNA-based vaccine, setting a target goal date in January 2022. However, at the time, an agency official suggested a decision was likely to come within two months, with the regulator said to have set an unofficial deadline for approval of around Labor Day on September 6.

Off-label use as booster

If BNT162b2 gains full approval, then the vaccine would be eligible for off-label prescriptions, such as booster doses, according to the FDA. Last week, Pfizer and BioNTech submitted Phase I data to the FDA supporting the use of a third dose of BNT162b2, with the application coming just days after the agency saying that it would permit third doses of mRNA vaccines to be given to certain immunocompromised individuals for extra protection against COVID-19. Shortly afterwards, US officials indicated that health agencies in the country are preparing to widely distribute third doses of mRNA COVID-19 vaccines beginning the week of September 20, citing new data that point to waning protection over time.

Meanwhile, full approval would also likely allow Pfizer to market BNT162b2 to doctors, providers and the general public. The vaccine generated sales of $7.8 billion in the second quarter of the year, up from $3.5 billion in the first quarter, while annual revenue from the product is seen reaching $33.5 billion, lifted from an earlier estimate of $26 billion.