US FDA authorizes Pfizer's Covid booster shots for elderly, high-risk Americans

Washington [US], September 23 : US Food and Drug Administration (FDA) on Wednesday (local time) authorized booster shots of the Pfizer COVID-19 vaccine for those aged 65 and older and adults at high risk.
People over 65 who had received Pfizer-BioNTech's coronavirus vaccine will get a booster shot at least six months after their second injection, said the US FDA, reported The New York Times (NYT).
Regulators said that people over 65 or at high risk of severe COVID-19 were eligible for an extra shot, setting up a staggering national booster campaign.
The FDA also authorized booster shots for adult Pfizer-BioNTech recipients who are at high risk of becoming severely ill with COVID-19 or are at risk of serious complications from the disease due to frequent exposure to the coronavirus at their jobs.
The authorization sets up what is likely to be a staggering campaign to deliver the shots, starting with the most vulnerable Americans. It opens the way for possibly tens of millions of vaccinated people to receive boosters at pharmacies, health clinics, doctors' offices and elsewhere, reported NYT.
Roughly 22 million Americans are at least six months past their second dose of the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention (CDC). About half of them are 65 and older. Millions of Americans who received the Moderna and Johnson & Johnson vaccines are still waiting to learn whether they, too, can get boosters.
The FDA's decision will be followed as soon as Thursday by a recommendation from the CDC, which issues guidance on vaccine policy for clinicians and public health officials throughout the United States.
An advisory committee of the CDC is now in the midst of a two-day meeting on the issue. But even if the CDC takes a different stance, health care providers are now authorized to offer third shots to Pfizer-BioNTech recipients who meet the FDA's eligibility criteria.
The ruling followed weeks of internal disagreement at the FDA, where some vaccine regulators openly challenged the idea of offering booster shots to the general population.
So far the FDA has cleared booster shots only for Pfizer-BioNTech recipients, and not all of them. Regulators are expected to take up whether to authorize the shots for recipients of the Moderna and Johnson & Johnson vaccines in short order, reported NYT.
"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 emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare 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," added Woodcock.
Wednesday's authorization made the United States the most recent wealthy nation to offer people booster doses, joining a list that includes Germany, France, Israel and Britain. Some public health experts say those doses should instead be directed to countries that have vaccinated far fewer of their residents.