U.S. gives Pfizer COVID-19 vaccine full approval

VANCOUVER – The Pfizer-BioNTech COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration.

The vaccine now carries the strongest endorsement from the FDA, which has never before had so much evidence to judge a shot’s safety

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said FDA acting commissioner Janet Woodcock, M.D.

#Breaking. U.S. Food and Drug Administration grants full approval for Pfizer-BioNTech Covid-19 vaccine.

— Mike Eppel (@eppman) August 23, 2021

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.

It’s been available to all individuals 16 years and older in the U.S. since December of last year. Emergency use authorization was then expanded in May of this year so the vaccine could be given to people between the ages of 12 and 15.

Related video: Elderly respond differently to Pfizer and Moderna vaccines: Study

 

The vaccine was first authorized for use, with conditions, by Health Canada in December 2020. That authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 was also expanded in May 2021 to include people aged 12 to 15.

The U.S. has now become the first country to fully approve Pfizer’s COVID-19 vaccine. The drugmaker’s CEO says he hopes the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”