FDA Grants Full Approval to Pfizer-BioNTech COVID Vaccine

Aug. 23, 2021

The federal Food and Drug Administration today granted full approval to the COVID vaccine developed by Pfizer-BioNTech for people 16 and older, making it the first to move beyond emergency use authorization status.  Researchers and volunteers in Rochester have been involved in the development of the vaccine since its inception.

“The Pfizer-BioNTech vaccine, along with the Moderna and Johnson & Johnson vaccines, have already undergone a rigorous review by the FDA for emergency use authorization,” said Ed Walsh, M.D., a professor in the University of Rochester Medical Center (URMC) Department of Medicine, Infectious Diseases. “As the first fully approved COVID vaccine, the public should be confident that this vaccine has met the FDA’s highest standards for safety and efficacy.”

In May 2020, 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 ultimately selected to move into phase 3 trials in July.  Volunteers in Rochester were the first in the nation to receive the vaccine as part of the phase 3 clinical trial.

These studies were led locally by Walsh and Ann Falsey, M.D., an Infectious Diseases professor at URMC.  Both are also members of the Infectious Diseases Unit at Rochester General Hospital.

The Pfizer-BioNTech coronavirus vaccine can also 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 technology and expertise behind these vaccines helped establish Pfizer’s vaccine development arm and subsequent collaboration between the company and URMC researchers on RSV, a respiratory virus, and seasonal coronaviruses contributed to the development of the current Pfizer-BioNTech COVID vaccine.

In approving the vaccine, the FDA reviewed data from 44,000 clinical trial participants in the US, Europe, South Africa, and South America. Pfizer-BioNTech reported that the studies show the vaccine was 91 percent effective in preventing infection, slightly down from the 95 percent reported when the FDA authorized the vaccine for emergency use in December 2020. 

“Millions of Americans have already received the Pfizer vaccine and the data shows that it is safe and highly effective in preventing severe illness, and even provides protection against known variants,” said Falsey.  “At the same time, we recognize that this is an important step and that FDA approval may provide the additional confidence necessary for people overcome their hesitancy and get vaccinated.”

For more information about COVID vaccine safety and efficacy, visit the Center for Disease Control and Prevention’s COVID-19 website.