Recommendation follows yesterday’s FDA authorization for emergency use of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2), to address the crisis
Based on urgent need, Committee recommends Pfizer-BioNTech COVID-19 vaccine for persons 16 years of age and older under U.S. FDA’s Emergency Use Authorization; earlier this month, the Committee recommended a phased allocation of vaccine distribution with Phase 1a to prioritize health care personnel treating patients, and residents in nursing homes and other long-term care facilities
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). This ACIP vote follows the December 1, 2020, ACIP recommendation for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities.

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ACIP advises the CDC on the types of populations and circumstances for which vaccines should be used. The advisors based today’s recommendation on the scientific evidence supporting the COVID-19 vaccine, including data from a Phase 3 clinical study announced last month and published in The New England Journal of Medicine on December 10, 2020, as well as on interim guidance that ACIP made on December 1, 2020 regarding the allocation of initial vaccine doses. The vaccine was authorized by the FDA on December 11, 2020 under an EUA while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

“Today’s ACIP recommendation marks a momentous step in this historic journey and the beginning of another, as we work jointly with the U.S. government, other vaccine companies and our many partners to execute the largest mass vaccination program in our nation’s history. Collectively, we aim to vaccinate hundreds of millions of Americans by the end of 2021,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “With vaccinations set to begin this week, I feel a sense of tremendous pride at what we have collectively achieved over the past nine months. I now look forward to the day that this devastating and deadly pandemic is finally behind us.”

“We started our project to develop a potential COVID-19 vaccine in January because we felt we had a duty to leverage our mRNA technologies and fast vaccine development competences to help address the pandemic,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We have the greatest respect for all the healthcare workers and people working day and night in long-term care facilities and hospitals. They have been taking care of so many people who needed help the most. Now, we feel honored to be able to support them by providing this vaccine.”

The first vaccine supplies are being prepared to ship from Pfizer’s Kalamazoo, MI site, and will be distributed by the U.S. Department of Defense in partnership with agencies within the Department of Health and Human Services (HHS), including the CDC, to government-designated facilities across the country.

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