Pfizer preps application for full COVID-19 vaccine authorization, seeks storage and EUA changes from FDA
May 4, 2021
Pfizer Inc. today said during its quarterly earnings call that it will file by the end of May for full Food and Drug Administration approval for its COVID-19 vaccine. More than 131 million doses of the Pfizer vaccine have been administered in the U.S. since it was authorized for emergency use in December. In seeking full authorization for adults ages 16 to 85, Pfizer is moving toward directly marketing the shot to consumers. Pfizer also indicated that it will seek FDA’s approval to change the agency’s existing storage guidance, enabling the vaccine to be kept at standard refrigerated temperatures for up to four weeks. The drug maker also expects a FDA decision soon on its application for the vaccine’s emergency use in adolescents aged 12 to 15.