The US Food and Drug Administration has granted full approval towards Pfizer and BioNTech’s COVID-19 Vaccine on Monday. This approval comes as the first COVID-19 vaccine to be fully approved by the FDA, and it hopes to spark confidence in American citizens to get theirs. The mRNA vaccine had previously only been approved for emergency use by FDA back in December, with more than 204 million Pfizer shots being issued since then.
Pfizer and BioNTech had submitted their application for full approval since early May, sending in a Biologics License Application for their vaccine specifically for those ages 16 and up. FDA scientists had gone over “hundreds of thousands of pages” of vaccine data comprising 40,000 trial participants, concluding that Pfizer’s mRNA vaccine had met the FDA’s standards. FDA commissioner Janet Woodcock said in a press statement that, “While millions of people have already safely received COVID-19 vaccines, we recognize for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.” PFE shares ended up 2.48% on Monday and down 4.35% by the end of Friday.