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Sunday, May 9th, 2021

Pfizer, BioNTech receive first emergency use authorization in world for COVID-19 vaccine

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With the temporary approval of the Medicines & Healthcare Products Regulatory Agency (MHRA), the United Kingdom has become the first country to initiate an emergency use authorization (EUA) for a COVID-19 vaccine created by Pfizer Inc. and BioNTech.

Earlier studies showed the vaccine to be 94.1 percent effective against COVID-19, and now, the MHRA says it is safe to be distributed to the public. Approximately 800,000 doses are scheduled to be shipped to the U.K. in short order. The companies have an agreement to supply a total of 40 million doses to the U.K. between 2020 and 2021.

Specifically, the vaccine now operates under a temporary authorization for emergency use, the first emergency use authorization following a global phase three COVID-19 vaccine trial.

“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19,” Albert Bourla, chairman and CEO of Pfizer, said. “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. 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.”

Now, citizens outside of clinical trials will, for the first time, have the potential to be immunized against COVID-19, although distribution will be prioritized among certain segments of the population. The companies also have reviews pending this month with the U.S. Food and Drug Administration (FDA) and EU’s European Medicines Agency (EMA).

“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,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said. “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 MHRA decision was based on a rolling submission of data. That data has shown that the vaccine provided efficacy across age, gender, race, and ethnicity demographics and spurred no serious safety concerns.