Posted by Michael Wonder on 04 May 2021
Pfizer will file for full FDA approval by end of May
4 May 2021 - Pfizer and BioNTech, the manufacturers of one of the three authorised COVID-19 vaccines in the U.S., plan to file for full approval from the FDA by the end of May as they expect the vaccine to generate about $26 billion in revenue this year.
The FDA grants emergency use authorisations when the Secretary of Health and Human Services deems it “appropriate” for the FDA to “authorise unapproved medical products or unapproved uses of approved medical products” when there are few or no alternatives.
