By Food and Drug Administration via POZ & PHARMATIVE
Third dose OK’d for people over 65, those at risk for severe COVID-19 and those at high risk of exposure to the coronavirus.
[On September 22], the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
- individuals 65 years of age and older;
- individuals 18 through 64 years of age at high risk of severe COVID-19; and
- individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
Today’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic. After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, MD. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”
The Process for Assessing the Available Data
Comirnaty (COVID-19 Vaccine, mRNA), was approved by the FDA on August 23, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. On August 25, 2021, the FDA received a supplement from Pfizer Inc. to their biologics license application for Comirnaty seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series for individuals 16 years of age and older.
As part of the FDA’s commitment to transparency, the agency convened a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on September 17 to solicit input from independent scientific and public health experts on the data submitted in the application. During the meeting, the vaccine manufacturer presented information and data in support of its application. The FDA also presented its analysis of clinical trial data submitted by the vaccine manufacturer. Additionally, the public was also given an opportunity to provide comment; and FDA invited international and U.S. agencies and external groups, including representatives from the Israeli Ministry of Health, the University of Bristol, U.K. and the Centers for Disease Control and Prevention, to present recent data on the use of vaccine boosters, epidemiology of COVID-19, and real-world evidence on vaccine effectiveness.
The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use. The booster dose is authorized for administration to these individuals at least six months following completion of their primary series and may be given at any point after that time.
It’s important to note that the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine is the same formulation as the FDA-approved Comirnaty and the vaccines may be used interchangeably.