The U.S. Food and Drug Administration announced on Wednesday, Sept. 22, that it had amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine boosters, allowing them to be used for specific parts of the population.
In its announcement, the FDA said that it now authorizes the use of a single booster dose to be administered at least six months after completion of the primary series for individuals aged 65 years and older; those aged 18 to 64 at high risk of severe COVID-19; and those whose frequent institutional or occupational exposure to COVID-19 puts them at high risk of serious complications of the disease.
The authorization applies only to the Pfizer-BioNTech vaccine that got full approval from the FDA on Aug. 23 for the prevention of COVID-19. The agency’s vaccine advisory committee on Sept. 17 voted against the plan to administer the shots to all eligible Americans. Instead, it recommended the third dose shot for recipients aged 65 years and above.
“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,” Acting FDA Commissioner Janet Woodcock said in a statement.
“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,” Woodcock said.
“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 commissioner said.
The authorization of vaccine boosters for the elderly and vulnerable individuals comes after President Joe Biden earlier this month directed the Labor Department’s Occupational Safety and Health Administration (OSHA) to issue orders requiring employers with 100 or more employees to mandate vaccination or require workers to submit to weekly COVID-19 testing.
Two top vaccine officials at the FDA decided to resign, reportedly due to disagreements with the Centers for Disease Control and Prevention (CDC) and its advisory committee for their involvement in decisions they think should be up to the FDA.