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Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the first Covid-19 vaccine in the United States to be assessed for full approval from the FDA. Pfizer's mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date. (Mascarenhas and Firger, 5/7)

Pfizer will have to demonstrate that it can reliably produce the vaccines to win full clearance. If approved, the companies could market their shots directly to consumers and possibly change the pricing of the doses. It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an “emergency.” (Kopecki, 5/7)

The vaccine was the first to be granted an emergency use authorization, or EUA, in December, for use in the U.S. ... Last year, the FDA said that in order to apply for an EUA for a Covid-19 vaccine, a drugmaker needed to provide two months of safety and efficacy data. A biologics license application — needed for full approval of a drug or vaccine — requires six months of data. “We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Pfizer chairman and CEO Albert Bourla said in a statement Friday announcing the application. (Edwards, 5/7)