July 19, 2021 -- The U.S. Food and Drug Administration has granted priority review status to the Pfizer/BioNTech coronavirus vaccine for people 16 and up, meaning the two-shot vaccine could gain full government approval by January 2022 at the latest.
However, full approval will probably come earlier, the FDA said in a news release. The review “has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance” of January 2022, the release said.
The Pfizer vaccine has been administered to people 16 and up under an emergency use authorization since mid-December. It was the first vaccine authorized by the government and is the most widely used in the United States.
Pfizer and its European partner BioNTech sought full approval by applying for a Biologics License Application in May. They’ve been submitting information on a rolling basis since then. The vaccine had already gone through rigorous clinical trials to receive the EUA.
Last spring, a Pfizer vaccine for people 12-15 was authorized. Pfizer and BioNTech said in a statement they’d apply for full approval for that vaccine once the required six months of data was available.
Full approval could help overcome vaccine hesitancy in people who now consider the vaccines experimental, give new momentum to the slumping national vaccination effort, and result in companies, schools, and the military issuing vaccine mandates.
Army Times reported last week that the U.S. army has told commanders to prepare “to administer mandatory COVID-19 vaccines as early as Sept. 1, pending full Food and Drug Administration licensure.”
Full approval would benefit the drug companies by allowing the vaccines to stay on the market once the COVID-19 pandemic is no longer considered an emergency, former FDA commissioner Robert Califf, MD, told CNBC last May. The companies could also market the vaccine directly to consumers, something they cannot do under an EUA, he said.
The number of COVID-19 cases, hospitalizations, and deaths have been driven down since the national vaccination program started in December. Still, less than half the U.S. population is fully vaccinated, according to the CDC.
Some health experts have argued that the FDA should quickly give full approval to the Pfizer and Moderna vaccines because that might increase confidence in the vaccines and help slow down the surging Delta variant.
Moderna applied for full approval in June for its vaccine, which uses mRNA technology like the Pfizer vaccine. Johnson & Johnson is expected to seek FDA approval for its one-shot vaccine.