Pfizer/BioNTech Ask FDA for Full Vaccine Approval
Pfizer and BioNTech have applied to the US Food and Drug Administration (FDA) for full approval of their Covid-19 vaccine in adolescents aged 12 to 15. If successful, the American-German duo’s shot now called Comirnaty would be the first in the US to obtain this status. It also was the first to win an emergency use authorization (EUA), in December 2020
In applications for a Covid-19 vaccine EUA, the FDA has required two months of safety and efficacy data. For full approval of a biologics license application, which grants marketing authorization, it requires six months of data. The agency is expected to take several weeks to review the Pizer-BioNTech application.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US government,” Pfizer chairman and CEO Albert Bourla said in a statement. More than 132 million doses of this vaccine have been administered in the US alone, according to the US Centers for Disease Control and Prevention, CDC.
Separately, the companies have applied for an EUA for their Covid-19 vaccine to be given to adolescents aged 12 to 15. News reports said the green light could come as early as this week. The vaccine would be distributed to pediatricians so parents could discuss questions but would also be available at pharmacies and community centers.
Pfizer is also working on an experimental oral drug to treat Covid-19 at the first sign of illness. Bourla said in late April that the protease inhibitor, which works by blocking an enzyme that the virus needs to replicate in human cells, could be available by the end of 2021.
Author: Dede Williams, Freelance Journalist
