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FDA Grants Pfizer EUA for COVID-19 Vaccine, Healthcare Leaders Jubilant

Analysis  |  By Jack O'Brien  
   December 12, 2020

According to Pfizer, the first doses of the vaccine are prepared to be delivered immediately.

The Food and Drug Administration (FDA) issued its first emergency use authorization for the COVID-19 vaccine developed by Pfizer Inc. and BioNTech Friday evening, a move that was warmly greeted by the healthcare industry as the U.S. and nations around the world continue to face unprecedented challenges caused by the pandemic.

The authorization allows for the emergency use of the vaccine in individuals that are 16 years of age or older and Pfizer stated that the company expects to file for possible full regulatory approval next year. 

According to the New York-based drugmaker, the first doses of the vaccine are prepared to be delivered immediately.

"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," FDA Commissioner Stephen M. Hahn, M.D., said in a statement.

Related: Discuss Mandatory COVID-19 Vaccinations Carefully

Alex Azar, Secretary of Health and Human Services, released a statement Friday evening calling the development "nothing short of a medical miracle."

"The triumph of Operation Warp Speed is a tribute to dedicated public servants across HHS and the Department of Defense, our partners in the private sector, and incredible American scientists," Azar said. "This vaccine, like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus. Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months. As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face coverings to protect ourselves, our loved ones, and our communities."

Related: Dr. Fauci Addresses Vaccination Rollout, Masking Challenges, At-home Testing

Additionally, CMS Administrator Seema Verma issued a statement Saturday morning that called the FDA's decision a "historic turning point in the fight against the virus."

"The beginning of the end of this chapter in our world’s history has arrived," Verma said. "Our hearts and minds continue to be with those who have lost loved ones, and I urge states to prioritize nursing homes and vulnerable seniors in their distribution of the vaccine. As we approach more widespread distribution, all Americans can take comfort in the fact that CMS has laid the groundwork to guarantee that every American can get the vaccine for free."

Healthcare leaders applaud FDA emergency authorization

Rick Pollack, CEO of the American Hospital Association, said this marks an "important step forward" towards ending the pandemic.

"In addition to playing an important role in vaccination efforts across the country, we also know that along with our physician and nursing partners, we have an important role to play in providing the public with clear and concise information that informs them about the benefits of being vaccinated," Pollack said. "This is especially important so that the public has the necessary confidence to allow them to make this important decision for their families and loved ones. Because of the long road ahead of us until COVID-19 vaccines are widely available, the AHA continues to urge the American public to wear masks, maintain physical distancing and wash their hands."

Related: Supply Is Limited and Distribution Uncertain as COVID Vaccine Rolls Out

Susan R. Bailey, M.D., president of the American Medical Association, released a statement Friday evening regarding the development.

"For much of this year, physicians, nurses and frontline health care personnel have done herculean, unprecedented work to care for patients and prevent the spread of COVID-19 – all while scientists and researchers sprinted to develop a safe and effective vaccine," Bailey said. "After a thorough, rigorous, transparent review process, today’s decision by the FDA to grant an Emergency Use Authorization (EUA) for the first COVID-19 vaccine developed by Pfizer and BioNTech is a monumental milestone with the potential to set us on a road to recovery. The comprehensive, science-based, transparent nature of this process is critical to inspiring the public’s confidence in this vaccine.

David J. Skorton, MD, CEO of the Association of American Medical Colleges (AAMC), said that the FDA's authorization was made possible by "decades of biomedical research within the academic medicine community."

"Even with the authorization of the first vaccine, we cannot expect an immediate stop to the spread of this illness," Skorton said. "The first shipments of the vaccine will begin to protect our most vulnerable frontline health care workers and those living in assisted living facilities. It will be several months before the vaccines are widely available and the vaccination rates are high enough to curb the pandemic. Until then, COVID-19 will continue to stretch the nation’s health care capacity to its limits, and we must continue the public health measures we know are effective, such as wearing a face covering in public, avoiding large gatherings– especially indoors– social distancing, and proper hand washing."

Andy Brailo, chief customer officer for Premier Inc., greeted the FDA's decision as "welcome news."

"The availability of vaccine doses in less than one year from COVID-19 onset in January of 2020 represents a remarkable scientific achievement and is a testament to American ingenuity and progress," Brailo said. "While a commercially available COVID-19 vaccine is an important milestone on the road to recovery, mass vaccination of the American people represents a monumental effort unlike any we’ve undertaken before. The distribution and administration of COVID-19 vaccines to the public will be the supply chain and population health challenge of the pandemic."

Related: Healthcare Groups Applaud Biden on Winning Presidency

Jack O'Brien is the Content Team Lead and Finance Editor at HealthLeaders, an HCPro brand.

Photo credit: Stafford /UK - November 9 2020: Pfizer vaccine Covid-19 concept. Syringe needle and a drop liquid on it, blurred Pfizer company logo on the background. Real photo, not a montage. / Editorial credit: Ascannio /

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