US FDA plans to allow a second updated Covid-19 booster for vulnerable Americans

WASHINGTON - The United States Food and Drug Administration (FDA) plans to allow older and immunocompromised Americans to get a second updated coronavirus booster shot in the near future, an acknowledgment of the virus’ continuing risks to vulnerable people whose

immunity might be sagging months after a previous inoculation.

Federal regulators are expected to authorise the additional dose in the next few weeks, according to people familiar with the agency’s planning.

Those aged 65 and older would be able to receive the vaccine at least four months after their previous updated shot. Those with immune deficiencies would also be eligible, and the vaccines would be free of charge.

Regulators are expected to authorise the additional dose without explicitly recommending it for those groups, a stance that emphasises the discretion of patients and their health providers.

Dr Rochelle Walensky, the director of the US Centres for Disease Control and Prevention (CDC), is expected to sign off on the decision – a customary step in the regulatory process.

Mr Michael Felberbaum, an FDA spokesman, said in a statement that the agency was monitoring data on the virus and would “base any decision on additional updated boosters upon those data”.

The decision reflects the Biden administration’s ongoing concerns about the durability of protection against the virus for those Americans most at risk, even as the pandemic’s threat to younger, healthier Americans has receded.

About 1,600 deaths from Covid-19 were reported for the week ending March 29, according to the most recent federal data. Those who are dying from Covid-19 are overwhelmingly 65 and older.

Looking to blunt the effects of a potential winter Covid-19 surge, the FDA authorised the retooled booster shots, which are aimed at Omicron sub-variants, at the end of August.

But only about 55 million Americans – less than 17 per cent of the population – have received an updated booster, according to the CDC. Among those 65 and older, 42 per cent have received one of the shots.

The Washington Post earlier reported the coming authorisation.

The Biden administration is planning to roll out another reformulated booster late in the summer or early in autumn, a schedule that would align with the annual flu vaccine.

In the coming months, regulators plan to select the version of the virus they want to target with that retooled booster.

In the meantime, a second booster for some groups would be in line with a proposal that regulators made at a January meeting of an independent group of vaccine advisers, at which the panel discussed offering vulnerable Americans more than one annual coronavirus shot.

At that meeting, federal health officials pointed to research that showed the reformulated boosters were still working to protect Americans against newer versions of the virus that circulated deeper into the winter.

The Biden administration has a substantial stockpile of the updated booster shots, and many of those doses could end up going to waste once a new booster is rolled out later in 2023.

Federal health officials purchased more than 170 million doses of the updated shots in 2022. A senior Department of Health and Human Services official said recently that the administration was considering donating some of the doses. NYTIMES