FDA Set to Approve Second COVID Booster for Select Individuals

The Food and Drug Administration (FDA) is set to authorize a second updated coronavirus booster shot for older and immunocompromised Americans. This acknowledgement comes as the virus continues to pose risks to vulnerable individuals whose immunity may decline months after their previous inoculation.

The additional dose is expected to receive regulatory approval in the coming weeks. Individuals aged 65 and older will be eligible to receive the vaccine at least four months after their previous updated shot. Those with immune deficiencies will also be included, and the vaccines will be provided free of charge.

The authorization will not explicitly recommend the additional dose for these groups but will emphasize the discretion of patients and their health providers. Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention (CDC), is expected to endorse this decision as part of the regulatory process.

The FDA spokesperson, Michael Felberbaum, stated that any decision on additional boosters would be based on data regarding the virus.

This decision reflects the Biden administration’s ongoing concerns about the durability of protection for high-risk Americans, despite a decrease in the pandemic’s threat to younger, healthier individuals. Recent federal data shows that the majority of COVID-19 deaths are occurring among those aged 65 and older.

To mitigate the potential impact of a winter COVID surge, the FDA authorized retooled booster shots specifically targeting omicron subvariants towards the end of August. However, only a small portion of the population, less than 17%, has received an updated booster, with only 42% of those aged 65 and older receiving one.

The Biden administration plans to introduce another reformulated booster later this year, aligning with the annual flu vaccine. In the meantime, the authorization for a second booster for certain groups aligns with a proposal made by regulators earlier this year. This proposal aimed to offer vulnerable Americans more than one annual coronavirus shot based on research showing the efficacy of retooled boosters against newer variants of the virus.

The administration currently holds a substantial stockpile of updated booster shots, and some doses may go to waste once a new booster is rolled out. The possibility of donating some of these doses is being considered by federal health officials.

[Source: The New York Times]

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