The agency authorised people over 65 who have received Pfizer-BioNTech’s coronavirus vaccine to get the booster shot at least six months after their second injection.
It also authorised the booster shots for adults who got Pfizer-BioNTech vaccinations who are at high risk of getting severely ill with Covid-19, or are at risk because they are frequently exposed to the virus at work.
“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.
“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 Centers for Disease Control and Prevention says that around 22 million Americans have had their second dose of Pfizer vaccine for at least six months. And around half of those are over the age of 65.
Americans who received the Moderna or Johnson & Johnson vaccinations are still waiting to be told if they will receive booster shots.
The CDC is expected to make its own decision on Pfizer booster shots by the end of the week, and regulators could quickly make further decision on the other two vaccines.
The US has now joined other countries, such as Britain, Germany, Israel and France in offering people booster shots, while poorer countries struggle to give their citizens a first round of vaccination.
On Wednesday President Biden announced that the US would double the number of Pfizer vaccines it is donating to other countries, as part of a goal to immunise 70 per cent of the world’s population by next year.
The US has seen more than 42.5m Covid cases during the pandemic, and more than 680,000 deaths.
Pfizer had asked the FDA to authorise a booster shot for everyone over 16 who has been vaccinated for six months.
But last week the agency’s outside advisory committee rejected that request, saying that there was not enough available data.
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