Nod to booster for US elderly
FDA opens controversial jab campaign
Washington, Sept. 23: People over age 65 and adults at high risk of severe Covid-19 can receive a booster dose of the Pfizer Inc.-BioNTech SE vaccine, the Food and Drug Administration said, opening a new and more controversial phase of the US immunisation campaign.
The emergency-use authorisation also allows boosters for people 18 and older whose occupational exposure to the SARSCoV-2 virus puts them at elevated risk of serious complications. Booster doses can be given any time at least six months after a person received their second shot, the FDA said in a statement.
Acting FDA Commissioner Janet Woodcock said the authorisation would allow people such as teachers and day-care staff, as well as health-care and grocery workers, to get the third shot.
The authorisation applies only to the Pfizer-BioNTech shot, the agency said. The emergency clearance is in line with a recommendation last week from FDA advisers but narrower than the full approval that Pfizer and its German partner had sought.
It means that the Biden administration will have to move more slowly on its planned wider rollout of boosters proposed last month.
Third doses were previously
authorised for certain people with compromised immune systems.
“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,” Pfizer Chief Executive Officer Albert Bourla said.
“Today’s FDA action is an important step in helping the most vulnerable among us remain protected from Covid-19.”
The authorisation leaves the door open for the FDA to consider broader use of boosters, including in younger adults, as more data on their safety and efficacy become available.