U.S. FDA Advisors Support Moderna COVID-19 Booster Injections for Elderly, High-Risk People – .

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U.S. FDA Advisors Support Moderna COVID-19 Booster Injections for Elderly, High-Risk People – .


A health worker holds a vial of Moderna COVID-19 vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in Manhattan in New York City, New York, United States , January 29, 2021. REUTERS / Mike Segar

October 14 (Reuters) – A panel of expert advisers from the United States Food and Drug Administration voted unanimously on Thursday to recommend booster shots of Moderna Inc’s (MRNA.O) COVID-19 vaccine for Americans 65 years of age and over and those at high risk of serious illness or occupational exposure to the virus.

If the FDA approves Moderna’s recall, the U.S. Centers for Disease Control and Prevention will make specific recommendations on who should get the vaccine. CDC advisers are due to meet next week.

The FDA’s Vaccines and Related Biologics Advisory Committee met on Thursday to review the additional dose of Moderna vaccine and will assess whether to make a similar recommendation for the Johnson & Johnson (JNJ.N) vaccine on Friday. . The vote to support Moderna’s booster was 19-0.

“The data itself is not solid, but it certainly points in the direction that is bearable of this vote,” said Dr. Patrick Moore of the University of Pittsburgh School of Medicine. Moore said he voted in favor of Moderna boosters based largely on “a sense of gut feeling rather than really hard data.”

Moderna shares rose nearly 3% to $ 330.71 after the vote.

FDA staff in documents released Tuesday said data from Moderna’s vaccine showed the booster increases protective antibodies.

But they also said the difference between antibody levels before and after the shot was not wide enough according to an FDA-specified measure of success, especially among those whose antibody levels remained high.

Moderna is seeking permission for a booster containing 50 micrograms of vaccine, half of its usual dose but still higher than the Pfizer (PFE.N) / BioNTech vaccine using similar technology at 30 micrograms.

The booster would be given to people at least six months after the initial inoculation as two injections.

U.S. health officials have come under pressure to allow booster doses of the COVID-19 vaccine after the White House announced in August that it was planning a large-scale recall campaign pending FDA and CDC approvals.

The two agencies signed Pfizer / BioNTech boosters for certain high-risk adults last month. Since then, nearly 9 million people have received a third injection, the CDC reported on Wednesday.

The panel heard presentations from Israeli health officials that Pfizer / BioNTech vaccine boosters helped curb the latest wave of infections in their country.

In Thursday’s presentation, they said the booster program in Israel improves protection against serious illnesses for people aged 40 and over.

“What we are 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 program, which now includes 50% of the population in all age groups, is starting to reduce infections even among the unvaccinated in Israel.

Dr Ofer Levy, a vaccine expert at Boston Children’s Hospital and a panel member, noted that the United States and Israel are different populations and that the vaccine used by Israel is different although similar to the Moderna vaccine.

Dr Hayley Gans, a pediatrician at Stanford University Medical Center and a panel member, asked if the Israeli Ministry of Health could say how much of the country’s waning Delta wave was attributable to the booster program and how much could have happened without them. .

“There is no doubt in my mind” that the booster injections were responsible for shifting Israel’s epidemic curve, Alroy-Preis replied.

In the United States, Delta’s surge has already started to ease, with the seven-day average of daily COVID-19 cases decreasing 12% from the previous week and the seven-day average of daily deaths falling. by 5%. read more It’s still more than 1,250 deaths from COVID-19 per day, mainly among the unvaccinated.

Reporting by Manas Mishra in Bengaluru, Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Caroline Humer in New York; Editing by Lisa Shumaker and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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