Experts Recommend Moderna Vaccine Booster to FDA for Elderly and Immunosuppressed

Sign outside FDA Headquarters in White Oak, Maryland

By Manas Mishra and Julie Steenhuysen

(Reuters) – A panel of expert advisors from the US Food and Drug Administration (FDA) on Thursday unanimously recommended a booster dose of Moderna’s Covid-19 vaccine for people aged 65 and older and those at high risk of serious illness.

If the FDA heeds the advisers’ recommendation and approves Moderna’s vaccine booster, the US Centers for Disease Control and Prevention (CDC) will make specific recommendations on who should receive it. The CDC is expected to meet to debate the issue next week.

The FDA’s Advisory Committee on Vaccines and Related Biologicals met Thursday to consider the additional dose of Moderna’s vaccine, and will assess whether to make a similar recommendation for the Johnson & Johnson immunizer on Friday. The vote to support the strengthening of Moderna was 19-0.

Moderna is seeking authorization for a booster that contains 50 micrograms of vaccine, half the strength of its normal dose, but still larger than Pfizer/BioNTech’s 30 microgram injection.

In addition to those 65 years of age and older and those at risk for severe Covid-19, the expert panel voted to recommend authorizing a third dose of Moderna’s vaccine for individuals aged 18 to 64 years at risk of frequent exposure to Covid infections. coronavirus due to work. Doses would be given at least six months after the initial two-dose inoculation.

US health officials are under pressure to authorize booster doses of Covid-19 vaccines after the White House announced in August that it planned a wide-ranging booster campaign, pending FDA and CDC approvals.

During the FDA advisors’ meeting, Israeli health officials said booster doses of Pfizer-BioNTech’s Covid-19 vaccine improved protection against severe disease in people 40 years and older.

“What we are seeing is a break in the epidemic curve in Israel,” said Sharon Alroy-Preis, director of public health services at the Israeli Ministry of Health.

She said the booster vaccination program, which now includes 50% of the population of all age groups, is starting to ease infections even among the country’s unvaccinated residents.

Israel, which closely monitors vaccines in its population, said in a slideshow that administering a booster dose led to greater protection against confirmed infections among people aged 16 and above.

(Additional reporting by Caroline Humer)

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