Pfizer clearance sets stage for broader booster push in US

NEW YORK • People over the age of 65 and adults at high risk of severe Covid-19 who have previously taken the Pfizer-BioNTech vaccine can receive a booster dose, the Food and Drug Administration (FDA) said, opening a new and more controversial phase of the US immunisation campaign.

The emergency-use authorisation also allows booster shots for people 18 and older whose occupational exposure to the Sars-CoV-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 Pfizer shot, the FDA said in a statement.

The decision applies only to the Pfizer-BioNTech shot, the agency said. Booster shots for recipients of the Moderna and Johnson & Johnson vaccines have not yet been cleared.

Acting FDA commissioner Janet Woodcock said the authorisation would allow people such as teachers and day-care staff, as well as healthcare and grocery workers, to get the third shot.

The emergency clearance for the Pfizer shot is in line with a recommendation last week from FDA advisers, but narrower than the full approval that the drug giant and its German partner had sought.

It also means the Biden administration will have to move more slowly on its planned wider roll-out of booster shots. 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 in a statement.

"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 booster shots, including in younger adults, as more data on their safety and efficacy become available. And it gives assurance that many of the older Americans who were first in line for the initial shots will be among the earliest to get additional protection.

Scientists have been divided on the need for boosters.

Real-world studies suggested that the efficacy of the Pfizer vaccine diminished somewhat this summer, especially in preventing mild breakthrough cases, though it is hard to distinguish waning immunity from the effects of the highly infectious Delta variant.

But other data have suggested that the shot provides lasting protection against severe disease leading to hospitalisation and death, and some researchers have said that booster shots for most people could be put off for some time.

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