Credit: Centers for Disease Control & Prevention
SILVER SPRING, MD (77WABC) — The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine. The approval allows for use of a single booster dose, to be administered at least six months after completion of the primary series.
The Food and Drug Administration on Wednesday signed off on such shots as a way to shore up protection in people with underlying health conditions and high-risk jobs.
The FDA is recommending the booster shot for:
- 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.
Wednesday’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine.
Today, we 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 6 months after completion of the vaccine’s primary series in certain populations. https://t.co/xF8h0kmF61 pic.twitter.com/3dsIhM9MoV
— U.S. FDA (@US_FDA) September 22, 2021
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
The deliberation follows a recommendation last week by the FDA’s independent scientific advisers that, while protection from vaccination is strong, immunity probably wanes after six months and is important to replenish for certain high-risk groups.
“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,” said Acting FDA Commissioner Janet Woodcock, M.D.
The advisory panel, called the Vaccines and Related Biological Products Advisory Committee, said last Friday there wasn’t enough evidence yet to recommend every vaccinated adult get a third dose.
This pandemic is dynamic and evolving, with new data about waning immunity in the vaccinated and the effects of booster doses becoming available every day.
— Dr. Janet Woodcock (@DrWoodcockFDA) September 22, 2021
Woodcock said those in the high-risk category could include “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”
But — this authorization is not a done deal yet: The Centers for Disease Control and Prevention has yet to weigh in on who it believes should get boosters and when.
Currently, only immunocompromised Americans are eligible for a third dose of the Pfizer or Moderna vaccine.
An estimated 2 million people have received a third mRNA based vaccine from the two manufacturers. Moderna and Johnson & Johnson have also asked the government to agree to booster shots for a larger population, and those requests are pending FDA review. FDA decisions are expected within the coming weeks.