News Detail

FDA Approves First COVID-19 Vaccine


The Pfizer-BioNTech Coronavirus vaccine received full approval from the U.S. Food & Drug Administration on Monday, August 23, 2021, making it the first to move beyond emergency use status in the United States.

From Acting FDA Commissioner Janet Woodcock, MD ... "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.  Today's milestone puts us one step closer to altering the course of this pandemic in the U.S." 

Since December 11, 2020, the Pfizer vaccine has been available for those 16 years and older under an 'Emergency Use Authorization' (EUA).  On May 10, 2021, EUA was expanded to include children ages 12 to 15; and, that authorization will continue until necessary data is collected for full FDA approval. Officials indicate it could be months before a decision on whether to authorize the vaccine for children younger than 12 is made.

FDA News Release of August 23, 2021 is available here.