BNT162b2 FDA EUA : Pfizer and BioNTech have been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for BNT162b2, their Covid-19 mRNA vaccine.
BNT162b2 has been authorized by the FDA for its use in the prevention of Covid-19 in individuals aged 16 years or more.
Pfizer and BioNTech will look to collect additional data and prepare to file a biologics license application (BLA) with the FDA seeking a full regulatory approval next year.
Recently, BNT162b2 was approved by Health Canada, and prior to that the Covid-19 vaccine from Pfizer and BioNTech by the UK and Bahrain.
Albert Bourla – Pfizer Chairman and CEO, commenting on BNT162b2 FDA EUA, said: “Pfizer’s purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19.
“As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”
BNT162b2 FDA EUA was granted based on the scientific evidence provided by Pfizer and BioNTech, which includes data from a phase 3 clinical study which showed a vaccine efficacy rate of 95%. The vaccine efficacy rate was recorded in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection.
No serious safety concerns were noted related to the vaccination with BNT162b2.
Commenting on BNT162b2 FDA EUA, Stephen M. Hahn – FDA Commissioner, said: “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.
“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
In July, Pfizer and BioNTech signed a $1.95 billion deal with the US government for supplying 100 million doses of BNT162b2.