The U.K. approved the Pfizer COVID-19 vaccine for emergency use on Wednesday, becoming the first country in the West to approve a COVID-19 vaccine for the general public.
“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.,” said Pfizer CEO Albert Bourla. “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.”
The vaccine was co-developed by Pfizer, an American pharmaceutical company, and BioNTech, a biotech company based in Germany. Pfizer previously said its vaccine is 95% effective against COVID-19, and also has 94% effectiveness with adults over age 65.
“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,” said Dr. Ugur Sahin, CEO of BioNTech. “Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”
The Washington Post reports that Britain previously ordered 40 million doses of the vaccine — which requires two doses per person — and government officials say they will have several million doses by the end of 2020. The U.S., on the other hand, has pre-purchased 100 million, and has an option to buy another 500 million doses.
According to the Associated Press, Pfizer expects to produce 50 million doses of vaccine before the end of the year and roughly half of those have been earmarked for the U.S.
The FDA is currently reviewing an emergency authorization application for the Pfizer vaccine, and is expected to make its decision shortly after December 10, 2020. Regulators say the U.S. review process takes longer because the FDA analyzes and validates raw data for the vaccine trials, whereas in Britain, regulators rely on Pfizer’s analysis of its own data to a greater degree than in the U.S., reports the New York Times.
“We’ve been waiting and hoping for the day when the searchlights of science would pick out our invisible enemy and give us the power to stop that enemy from making us ill. And now, the scientists have done it,” said Prime Minister Boris Johnson in a press conference Wednesday evening, reports the Post.
“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,” said Dr. Ugur Sahin, CEO of BioNTech. “Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”