Pfizer to seek authorization of COVID-19 vaccine Friday
Fri, 11/20/2020 – 10:30
Pfizer announced that it plans to ask FDA on Friday for emergency use authorization of its COVID-19 vaccine. Pfizer and partner BioNTech reported this week the two-dose vaccine was 95% effective and well-tolerated. It is not clear how long it will take the agency to review the vaccine, but it will likely move quickly, given the urgency of the situation. FDA has said it plans to hold COVID-19 vaccines to the same stringent standards required for a full approval. The Pfizer and BioNTech vaccine uses messenger RNA, as does one from Moderna, which also recently reported positive results. An independent panel of experts will meet soon to review data on the vaccine and advise FDA. The panel will likely consider whether the vaccine was shown to work safely in various racial, ethnic, and age groups, and will give a recommendation on whether the vaccine should be authorized and for whom. FDA could authorize the vaccine broadly for the U.S. population, or it could limit it to certain groups, such as older adults.