US authorises Pfizer booster dose for those aged 65 and older
Roll-out of booster shots may be as soon as this week for millions of people including healthcare workers
WASHINGTON: The US Food and Drug Administration (FDA) authorised a booster dose of the Pfizer-BioNTech Covid-19 vaccine for those aged 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.
The decision paves the way for a quick roll-out of the booster shots as soon as this week for millions of people who had their second dose of the vaccine at least six months ago.
The change to the vaccine's emergency use authorisation will allow boosters for groups such as healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, FDA Acting Commissioner Janet Woodcock said in a statement.
Pfizer had asked the FDA to expand its vaccine approval to include boosters for all people aged 16 and older, and presented data last week to an outside FDA panel of advisers.
The panel voted against the proposition that boosters were needed by everyone but said evidence showed they were helpful to older people and those at high risk.
Dr William Schaffner, medical director of the National Foundation for Infectious Diseases (NFID), said the FDA's statement was more expansive in who it included as eligible for boosters when compared with the panel's recommendation.
"Very broad indeed, especially that 'among others'. That could essentially give the green light for giving boosters to a very substantial proportion of the previously vaccinated adult population," said Dr Schaffner, who serves as the NFID's liaison to the Advisory Committee on Immunisation Practices (Acip) at the US Centres for Disease Control and Prevention.
Acip could vote yesterday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.
The FDA authorisation was "generally in line" with the advisory panel vote, said Dr Jesse Goodman, an infectious disease expert at Georgetown University in Washington and former chief scientist at the FDA.
"These are pretty broad categories that give a fair amount of latitude to the judgment of healthcare providers and people providing immunisations," he added.
"This first FDA authorisation of a Covid-19 vaccine booster is a critical milestone in the ongoing fight against this disease," said Pfizer chief Albert Bourla.
The company had argued that boosters are needed for the general population.
Top FDA members have been split on the need for boosters for the general population, with Ms Woodcock backing them while some of the agency's senior scientists argued that current evidence does not support them.
Some countries, including Israel and Britain, have already rolled out Covid-19 booster campaigns. - REUTERS