Pharmaceutical companies Pfizer and BioNTech received full approval from the US Food and Drug Administration (FDA) on Monday, August 23, for its COVID-19 vaccine. The vaccine had received emergency use authorization (EUA) in December 2020.
The two-dose vaccine which can be administered to individuals above 16 years received the drug regulator’s approval. The vaccine named ‘COMIRNATY’ was found to have 91% efficacy in clinical trials.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated,” said Acting FDA Commissioner Janet Woodcock.
The approval came at a time when the USA trying to solve the issue of vaccine hesitancy.
Speaking about the FDA approval, President Joe Biden said,” If you’re one of the millions of Americans who said that they will not get the shot when it’s — until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for is here, and it’s time for you to go get your vaccination and get it today.”
Biden further said that almost 50 million Americans have taken at least the first dose of vaccine.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.” Albert Bourla, CEO of Pfizer said in a statement.
According to Reuters, U.S. cities including New York and San Francisco have already imposed rules requiring vaccination to dine at restaurants or work in government offices, among other activities.
