A panel of expert advisers to the U.S. Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna Inc’s COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.
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. CDC advisers are scheduled to meet next week.
The FDA’s Vaccines and Related Biological Products Advisory Committee met on Thursday to consider the additional dose of the Moderna vaccine and will weigh whether to make a similar recommendation for Johnson & Johnson’s vaccine on Friday. The vote to back Moderna’s booster was 19-0.
“The data itself is not strong, but it is certainly going in the direction that is supportable 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 “gut feeling rather than truly serious data.”
Moderna shares were up nearly 3% at $330.71 after the vote.
FDA staff in documents posted on Tuesday said data for Moderna’s vaccine showed that the booster does increase protective antibodies.
But they also said the difference in antibody levels before and after the shot was not wide enough by one measure of success specified by the FDA, particularly in those whose antibody levels had remained high.
Moderna is seeking authorization of a booster that contains 50 micrograms of vaccine, half of strength of its regular dose but still higher than the Pfizer/BioNTech shot using similar technology at 30 micrograms.
The booster would be administered to people at least six months after the initial two-shot inoculation.
U.S. health officials have been under pressure to authorize COVID-19 vaccine booster doses after the White House announced in August it planned a widespread booster campaign pending approvals from the FDA and the CDC.
Both agencies signed off on Pfizer/BioNTech boosters for certain high-risk adults last month. Since then, nearly 9 million people have received a third shot, the CDC reported on Wednesday.
The panel heard presentations from Israeli health officials that boosters of the Pfizer/BioNTech vaccine helped curb the latest wave of infections in their country.
In the presentation on Thursday, they said the booster program in Israel improved severe disease protection in people aged 40 and older.
“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 program, which now includes 50% of the population among 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 Israel used is different although similar to the Moderna shot.
Dr. Hayley Gans, a Stanford University Medical Center pediatrician and panel member, asked whether Israel’s health ministry could tell how much of the country’s waning Delta wave was attributable to the booster program and how much might have occurred without them.
“There is no question in my mind” that booster shots were responsible for the change in Israel’s epidemic curve, Alroy-Preis responded.
In the United States, the Delta surge already has been begun to ease, with the seven-day average of daily COVID-19 cases falling 12% from the previous week, and the seven-day average of daily deaths down 5%. That is still more than 1,250 COVID-19 deaths a day, however, primarily among the unvaccinated.
- FDA’s First Tests For "Forever Chemicals" In Food Found Them In Meat And Chocolate Cake
- Nektar withdraws application for opioid painkiller after FDA panel's vote
- Flu Shot Facts & Side Effects
- Here's Why You Absolutely Need To Get A Flu Shot This Year, According To Experts
- Patients at risk for heart problems should be cautious about using marijuana
- High-profile forensic psychiatrist, who raised suspicions about JonBenet Ramsey's family during her murder investigation, is shot dead outside his office
- How a good economy may equal a BAD flu season: Each 1% jump in employment rate 'is linked with a 19% bump in flu-related doctors' visits'
- 'Shot across the bow': U.S. steps up pressure on UK ahead of Huawei decision
- Baton Rouge, New Orleans area People in Business for Jan. 19, 2020
- One of These People Could Beat Trump, Right?
- Health officials expect MORE coronavirus cases in the US and admit that 1st American patient was not diagnosed for five DAYS after returning from Ground Zero of Wuhan and had contact with at least 16 people
- A first: Drug lowers heart risks by curbing inflammation
- Cooler weekend ahead as temperatures drop below 30C for the first time in a week... but the scorching weather will be back with 35C highs by Wednesday
- HPV vaccine row as Government says it will almost eradicate the risk of cervical cancer for young women... but researchers say the evidence is 'insufficient'
- An Extraordinary Indian: Risking his life to save others
- Movies on TV this week: Jan. 19-25: ‘Raiders of the Lost Ark’
- UK cold weather alert: Vulnerable at risk as temperatures could fall to -7C
- Flu Hits Young People Hard This Season: 4 Child Deaths In GA
- Doctors urged to advise patients about risks of abstinence-centric sex education
- People who use tranformative power of pets to help others could win up to £90,000 of investment
U.S. FDA advisers back Moderna COVID-19 booster shots for older and high-risk people have 901 words, post on tuoitrenews.vn at October 15, 2021. This is cached page on Talk Vietnam. If you want remove this page, please contact us.