The FDA has granted full approval to Pfizer’s COVID-19 vaccine, Comirnaty, for individuals aged 16 and older. The approval follows an Emergency Use Authorization that was granted to this vaccine in December 2020, less than a year after Pfizer’s partner, BioNTech, started working on the mRNA vaccine. The FDA based the approval on the review of additional data, including updated clinical trial results and longer duration safety follow-up.
The review found that the vaccine was 91% effective in preventing COVID-19 disease. Commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. Postmarketing data identified increased risks of myocarditis and pericarditis, particularly in males under 40 years of age.
The vaccine is available for 12 to 15 year olds, under Emergency Use Authorization.
Comirnaty is the first mRNA vaccine to secure FDA approval. Pfizer expects to deliver 2.1 billion doses of the vaccine by the end of 2021, earning US$33 billion in revenue.
Moderna has submitted an application for full FDA approval of its mRNA vaccine.
