Statement from Jesse L. Goodman, MD, MPH, on FDA Approval of Pfizer-BioNTech’s COVID-19 Vaccine

WASHINGTON (August 23, 2021) – Today, the US Food & Drug Administration approved the two-dose COVID-19 Pfizer-BioNTech vaccine. Jesse L. Goodman, MD, MPH, professor of medicine and infectious diseases at Georgetown University Medical Center and former FDA Chief Scientist shares the following comments: 

“FDA’s full approval today of the Pfizer-BioNTech vaccine is great news and it marks a major accomplishment for humanity. It also means that FDA staff scientists have completed their detailed review and analysis on available data from the thousands of individuals in clinical trials as well as millions who have received the vaccine under Emergency Use Authorization.

“In addition to evaluating the vaccine’s safety and efficacy in preventing COVID, FDA has thoroughly reviewed its manufacturing methods, facilities and quality. FDA’s full approval means the vaccine has met the very high standards required of all the approved vaccines we rely on every day for ourselves and our families, and confirms that the benefits of the vaccine in preventing COVID and its complications are clear-cut and far outweigh any risks.  

“I hope that knowing FDA experts invested tremendous time and effort to perform this complete and independent review, while the vaccine has been available for emergency use, now helps anyone who still has concerns gain confidence, and will add many of them to the over a million seeking vaccine every day to keep themselves, their families and their communities safe.  

“At present, nearly 150,000 COVID infections are occurring each day in our country with approximately a thousand Americans dying from the virus, resulting in unimaginable tragedy for families and loved ones, and stressing our healthcare system to the breaking point. 

“Getting vaccinated now remains the best way to reduce the risk of hospitalization and death from the virus and to help control the terrible toll of this pandemic.”

Download the audio file of this statement here. To schedule an interview, please contact Karen Teber at [email protected].

About Georgetown University Medical Center

As a top academic health and science center, Georgetown University Medical Center  provides, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human

health. Patient care and clinical research is conducted with our clinical partner, MedStar Health. GUMC’s mission is carried out with a strong emphasis on social justice and a dedication to the Catholic, Jesuit principle of cura personalis — or “care of the whole person.” GUMC comprises the School of Medicine, the School of Nursing & Health Studies, Biomedical Graduate Education, and Georgetown Lombardi Comprehensive Cancer Center. Designated by the Carnegie Foundation as a “very high research activity university,” Georgetown is home to a Clinical and Translational Science Award from the National Institutes of Health, and a Comprehensive Cancer Center designation from the National Cancer Institute. Connect with GUMC on Facebook (Facebook.com/GUMCUpdate) and on Twitter (@gumedcenter).

 

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