U.S. FDA clears Pfizer booster for older and at-risk Americans

The decision paves the way for a quick rollout 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 authorization will allow boosters for groups such as health-care workers, teachers and day care 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 that it said showed waning immunity over time.

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.

ACIP could vote Thursday 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 authorization 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 immunizations," he added.

But the advisory panel said there was not enough evidence to support booster shots for that population and also sought more safety data. The FDA does not have to follow the advisory panel's recommendation, but often does.

Some countries, including Israel and Britain, have already rolled out COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and over 2 million people have already received a third shot, CDC data showed.