October 14 (Hfrance.fr) - The advisers of the US Food and Drug Administration were to vote on Thursday on the timeliness of third dose of (MRNA.O) COVID-19 vaccine should be cleared after hearing from Israeli health officials that Recalls of a similar vaccine have helped curb the latest wave of infections in their country.
Israeli health officials, in their presentation Thursday, said booster doses of Pfizer (PFE.N) / BioNTech COVID-19 vaccine improved protection against serious illness in people aged 40 and over.
FDA advisers will assess the need for a booster dose of Moderna vaccine at least six months after the initial two-shot inoculationns for people aged 65 and over, those at high risk of severe COVID-19, and those aged 18 to 64 at risk of frequent exposure to coronavirus infections due to their work.
Moderna requests authorization of a booster which contains 50 micrograms of vaccine, half the strength of its regular dose but still higher than the Pfizer vaccine / BioNTech at 30 micrograms.
Immunocompromised individuals would still receive a full dose 100 microgram vaccine for their third injection because they do not respond well to the regimen at two original doses.
If the FDA approves Moderna 'As a reminder, the United States Centers for Disease Control and Prevention will make specific recommendations on who should get the vaccine. CDC advisers are due to meet next week.
United States health officials have been under pressure to allow COVID-19 vaccine booster doses after the White House announced in August that it was planning a large-scale recall campaign pending FDA and CDC approval.
Both agencies signed on Pfizer / BioNTech boosters for some high-risk adults last month. Since then, nearly 9 million people received a third injection, the CDC reported on Wednesday.
Data on the need for boosters largely comes from Israel, which has rolled out additional injections of the Pfizer / BioNTech vaccine to large sections of its population, and has provided details of the effectiveness of this effort to US advisers.
No populations of similar studiesres in the real world exist for Moderna or Johnson & Johnson (JNJ .N) vaccines.
'A BREAK IN THE EPIDEMIC CURVE '
Israeli health officials told FDA advisers the percentage of positive COVID-19 tests began to decline nationwide after boosters were given to most drug groups 'age.
"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 recall 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 Boston Children's Hospital vaccine expert and panel member, however, said it is important to remember 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, Stanford University Medical Center pediatrician and panel member, asked if Israel's health ministry could say how much of the country's waning Delta wave was attributable to the recall program and how much could have happened without them.
"There is no doubt in my mind " that the booster injections were responsible for the change in the epidemic curve in Israel, replied Alroy-Preis.
FDA staff in documents published Tuesday reported data for Moderna 'The vaccine showed that the booster increases protective antibodies. But they also said the difference between the antibody levels before and after the shot was not large enough in one study, especially in those whose levels remained high.
If a recall is allowed, Moderna has stated that new vials would not be needed, so there should be no delay in the availability of the recall due to packaging.
in the United States, the delta surge has started to ease, the seven-day average of daily COVID-19 cases decreasing by 12 % from the previous week and the seven-day average of daily deaths down 5%. read more It's still more than 1,250 COVID-19 deaths per day, mainly among the unvaccinated.
FDA advisers are expected to consider booster shots for J&J's single-dose vaccine on Friday. Reporting by Manas Mishra in Bengaluru, Julie Steenhuysen in Chicago, Mich ael Erman in New Jersey and Caroline Humer in New York; Edited by Lisa Shumaker and Bill Berkrot
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