U.S. FDA advisers weigh case for booster shots of Moderna COVID-19 vaccine

by Reuters
Thursday, 14 October 2021 15:05 GMT

(Adds details from panel meeting, background)

By Manas Mishra and Julie Steenhuysen

Oct 14 (Reuters) - Israel health officials on Thursday said booster doses of the Pfizer-BioNTech COVID-19 vaccine improved severe disease protection in people aged 40 and older, in presentations made to U.S. scientists discussing a booster dose of Moderna's vaccine.

The data was reported at a meeting of outside advisers to the U.S. Food and Drug Administration who are expected to vote later on Thursday on the need for a third dose of the Moderna vaccine at least six months after the initial two-shot inoculation. The FDA typically follows the advice of its experts but is not bound to do so.

Moderna is seeking approval of a booster shot that includes 50 micrograms of vaccine, half of strength of its regular dose but still higher than the Pfizer-BioNTech shot, which contains 30 micrograms of vaccine.

Dr. Ofer Levy, a panel member, said it is important to remember that the United States and Israel are different populations and that the vaccine Israel used is different, but he added that as both use similar mRNA technology the Israel findings are relevant.

The panel will vote on whether Moderna boosters should be given six months after the second dose to individuals aged 65 and over, those at high-risk of severe COVID-19 and to people ages 18 to 64 who are at risk of frequently exposed to coronavirus infections due to their jobs.

If the FDA signs off on Moderna's booster, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the shots.

"What we're seeing is a break in the epidemic curve in Israel," said Dr. Sharon Alroy-Preis, director of public health services at the Ministry of Health in Israel.

She said the booster vaccination program, which now includes 50% of the population among all age groups, is starting to reduce infections https://tmsnrt.rs/34pvUyi even among the unvaccinated populations in Israel.

Israel, which has been closely monitoring vaccines https://tmsnrt.rs/3tUM8ta in its population, said in a slide presentation that administering a booster dose led to greater protection against confirmed infection in those aged 16 and above.

(Reporting by Manas Mishra in Bengaluru, Julie Steenhuysen in Chicago and Caroline Humer; Editing by Hugh Lawson, Lisa Shumaker and Bill Berkrot)

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