FDA authorises Covid-19 booster shots for over 65s
Covid-19 vaccines updates
Sign up to myFT Daily Digest to be the first to know about Covid-19 vaccines news.
The Food and Drug Administration has approved a third shot of the BioNTech/Pfizer Covid-19 vaccine for vulnerable Americans including those aged 65 years and up and working in high-risk jobs such as healthcare.
The decision to restrict third shots is a heavy blow to the US government’s plans for a widespread booster campaign and comes after the FDA’s advisory committee last week voted unanimously against authorising a booster for all individuals aged over 16.
Third doses will be offered to all people aged over 65 and those aged 18 to 64 at risk of severe Covid or who work in places with a high risk of exposure to the coronavirus.
The booster has been authorised to be administered at least six months after a person is fully vaccinated.
“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 Janet Woodcock, acting head of the FDA.
She added that boosters would be available for “certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others”.
Last week the agency’s scientific advisers questioned the need for all over 16s to get a third shot given the risk of rare heart-related side effects, especially in younger people.
Pfizer has urged the need for boosters, saying that vaccine efficacy wanes over time and the Biden administration had marked September 20 as the date from which boosters would become available.
Washington’s involvement ahead of regulatory decisions has been criticised by some scientists and led to the retirement of two top FDA members earlier this month.
“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated,” said Albert Bourla, chief executive of Pfizer.
“Today’s FDA action is an important step in helping the most vulnerable among us remain protected from Covid-19,” he added.
The FDA’s decision comes after Joe Biden’s vaccine summit on Wednesday, during which the US president committed to donating 500m more doses of the BioNTech/Pfizer jab to poorer countries.
During a meeting of the Centers for Disease Control’s vaccine advisory group on Wednesday, Natalie Thornburg, a CDC scientist, presented data showing that although antibody levels decline over time, cellular memory is maintained.
The scientists also questioned whether the BioNTech/Pfizer jab should be approved ahead of the Moderna booster, which could lead to confusion if people can only receive a third dose from the same company as their initial vaccine series.
The CDC group will meet again on Thursday to discuss booster vaccines.
Latest coronavirus news
Follow FT’s live coverage and analysis of the global pandemic and the rapidly evolving economic crisis here.