INDIANAPOLIS — On Wednesday, the U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for certain populations.
The authorization allows for a single booster dose to be administered at least six months after completion of the first two primary doses of the vaccine. Those who are eligible for the booster include:
- Individuals who are 65 years of age and older.
- Individuals 18 through 64 years of age at high risk of severe COVID-19.
- Individuals 18 through 64 years of age who frequent institutional or occupational exposure to COVID-19 (such as healthcare workers) puts them at high risk of serious complications of the illness including severe COVID-19.
“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, M.D. “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.”