FDA Approves Pfizer Coronavirus Vaccine: Vaccination Begins in Frontline Health Care Workers

Dec. 10, 2020

Update – December 15, 2020: On December 11, 2020, the FDA issued an Emergency Use Authorization for the Pfizer/BioNTech COVID-19 vaccine. This allows the vaccine to be distributed in the U.S. for use in individuals 16 years of age and older.

On December 14, 2020, URMC began vaccinating frontline health care workers, in accordance with federal and state guidelines. Initially, supplies of the vaccine will be limited, but as the availability of approved vaccines increases in 2021, URMC plans to provide a coronavirus vaccination to any UR Medicine patient who wants one. Learn more about coronavirus vaccine distribution, safety and efficacy, and review frequently asked questions.

An interim analysis of study data from a coronavirus vaccine being developed by Pfizer and BioNTech indicates that the vaccine is highly effective in preventing COVID-19.  Researchers and volunteers in Rochester have been involved in the testing of the vaccine since May, when the first human studies were launched, and technologies used in the development of the vaccine can trace their origins to decades of infectious disease research conducted at the University of Rochester Medical Center (URMC).    

COVID vaccine research

“While we need to keep in mind that the study is ongoing and this is a preliminary analysis, the data is very encouraging,” said Ed Walsh, M.D., a professor in the URMC Department of Medicine, Infectious Diseases.  “We need to continue the process of rigorous analysis of this and other potential vaccines to ensure they are safe and effective, and this will take time.  However, I think it is safe to say that, if these findings hold up, we can start to see the light at the end of the tunnel.”

Pfizer today announced that an interim analysis by an independent data and safety review board indicated that the vaccine is 90 percent effective in preventing infection.  The data is based on more than 40,000 phase 3 study participants in the U.S., Argentina, Brazil, and Germany.  The clinical trial is ongoing and Pfizer has indicated that it anticipates submitting formal data to the FDA later this month for review.  The company also said that it will have 50 million doses of the vaccine ready by the end of the year and an additional 1.3 billion doses available globally in 2021. 

The local arm of the Pfizer/BioNTech study is led by Walsh and Ann R. Falsey, M.D., co-director of the URMC Vaccine and Treatment Evaluation Unit.  Both are also members of the Infectious Disease Unit at Rochester General Hospital. 

In May, URMC and Rochester Regional Health began enrolling participants in a phase 1 clinical trial of the Pfizer/BioNTech vaccine candidates. Rochester was one of only four sites in the U.S. involved in this early stage study.  That trial evaluated four variations of the vaccine and the version that was tested in Rochester, named BNT162b2, was selected to move into phase 3 trials in July.  Volunteers in Rochester were the first in the nation to be dosed in the phase 3 clinical trial of the vaccine.

Walsh and Falsey were co-authors of a study that appeared last month in the New England Journal of Medicine that showed that the BNT162b2 vaccine was safe and elicited an immune response to the virus during the phase 1 clinical trial. 

The Pfizer/BioNTech coronavirus vaccine study can trace its roots back to decades of research done at URMC to improve the efficacy of vaccines and develop new vaccines against Hib, a bacterium that causes meningitis and pneumonia, and HPV, the virus that causes cervical cancer. 

The research behind the Hib vaccine led to the creation of Praxis Biologics, which was formed in the 1980’s as a URMC start-up company.  That company was eventually acquired by Pfizer and many of the scientists who worked at Praxis moved to Pfizer and helped establish the company’s vaccine development division. The team at Pfizer continued to collaborate with researchers in Rochester and subsequent technological and scientific advances made by URMC researchers studying RSV, a respiratory virus, and seasonal coronaviruses contributed to the COVID-19 vaccine currently being developed by Pfizer and BioNTech. 

URMC is currently enrolling participants in another coronavirus vaccine being developed by AstraZeneca and the University of Oxford.   It is anticipated that URMC will be joining additional vaccine studies in the coming months. 

“While today’s results are most welcome and indicate that we have made significant progress, it remains essential that we continue to press forward with studies of other potential coronavirus vaccines,” said Falsey, who is a national coordinating investigator for the AstraZeneca vaccine study.  “Given the challenges and logistics of vaccine distribution on a global scale, we will require multiple effective vaccines and we are incredibly grateful to the thousands of people in our area who have stepped forward to participate in vaccine research.”

Individuals interested in learning more about volunteering for vaccine studies should call (585) 276-5212 or visit