FDA authorizes second updated Covid reminder for the elderly and immunocompromised

Federal regulators plan to authorize an additional dose for the elderly and immunocompromised in the coming weeks, before the introduction of a booster newly formulated later in the year.

WASHINGTON — The Food and Drug Administration plans to allow older, immunocompromised Americans to receive a second updated coronavirus booster in the near future, an acknowledgment of continuing risks from the virus for vulnerable people whose immunity could wane months after a previous inoculation.

Federal regulators are expected to authorize the additional dose in the coming weeks , according to people familiar with the planning agency. People 65 and older could get the vaccine at least four months after their previous update. Immunocompromised people would also be eligible and vaccines would be free.

Regulators should allow the extra dose without explicitly recommending it for these groups, a position that emphasizes the discretion of patients and their healthcare providers. Dr. Rochelle P. Walensky, director of the Centers for Disease Control and Prevention, is expected to approve the decision - a usual step in the regulatory process.

Michael Felberbaum, an F.D.A. spokesperson, said in a statement that the agency was monitoring data on the virus and "would base any decisions on additional updated boosters on this data".

The decision reflects the Biden administration's lingering concerns about the sustainability of virus protection for 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 die from Covid-19 are overwhelmingly aged 65 and older.

Seeking to mitigate the effects of a possible winter surge of Covid, the F.D.A. authorized revamped booster shots, which target Omicron subvariants, at the end of August. But only about 55 million Americans — less than 17% of the population — have received an updated reminder, according to the C.D.C. Of those age 65 and older, 42% have received one of the injections.

The Washington Post earlier announced the upcoming clearance.

The Biden administration plans to roll out another reworded booster in late summer or early fall, a schedule that would align with the annual vaccine against influenza. In the coming months, regulators plan to select which version of the virus they wish to target with this revamped booster.

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

At this meeting, federal health officials pointed to research that showed reworded reminders still work to protect Americans from newer versions of the virus circulating deeper into winter.

The Biden administration has a substantial stockpile of updated recalls, and many of those doses could end up wasted once a new booster rolls out later this year. Federal health officials purchased more than 170 million doses of the updated vaccines last year. A senior Department of Health and Human Services official recently said the administration is considering donating some doses.