Pfizer and BioNTech First in the World to Receive Emergency Authorization of COVID-19 Vaccine

December 2, 2020
Sydney Jennings

Associate Editor of Patient Care Online

The United Kingdom became the first country to grant emergency use authorization for a vaccine to combat COVID-19.

The Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom became the first global agency to authorize a supply of coronavirus disease 2019 (COVID-19) vaccine for emergency use.

The MHRA granted Pfizer and BioNTech a temporary authorization for emergency use of their COVID-19 mRNA vaccine, BNT162b2, following a global phase 3 trial that demonstrated a vaccine efficacy rate of 95%, according to a December 2, 2020, Pfizer press release.

“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19,” said Albert Bourla, chairman, chief executive officer (CEO), Pfizer, in the press release. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

In the phase 3 trial, BNT162b2 demonstrated a vaccine efficacy rate of 95% (P<.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and in participants with and without prior SARS-CoV-2 infection (second primary objective), 7 days after the second dose.

The first primary objective analysis was based on 170 cases of COVID-19 and efficacy was consistent across age, gender, race, and ethnicity demographics, with an efficacy rate of >94% in participants aged ≥65 years.

Also, BNT162b2 was generally well tolerated with no serious safety concerns, according to the press release.

Both Pfizer and BioNTech have filed a request for emergency use authorization with the US Food and Drug Administration and a decision is expected in December. The first doses in the United Kingdom are expected to arrive in the coming days.

“We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it,” said Ugur Sahin, MD, CEO, co-founder, BioNTech, in the Pfizer press release.

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