Moderna makes booster shot case to U.S. advisers, leaning on Israel data, company studies

Israeli health officials, in their presentation on Thursday, said booster doses of the Pfizer/BioNTech COVID-19 vaccine improved severe disease protection in people aged 40 and older. The FDA advisers will weigh the need for a booster dose of the Moderna vaccine at least six months after the initial two-shot inoculation for those aged 65 and over, people at high-risk of severe COVID-19 and individuals ages 18 to 64 at risk of frequent exposure to coronavirus infections due to their jobs.

Advisers to the U.S. Food and Drug Administration on Thursday were set to vote on whether a third dose of Moderna Inc's COVID-19 vaccine should be authorized after hearing from Israeli health officials that boosters of a similar vaccine helped curb the latest wave of infections in their country. Israeli health officials, in their presentation on Thursday, said booster doses of the Pfizer/BioNTech COVID-19 vaccine improved severe disease protection in people aged 40 and older.

The FDA advisers will weigh the need for a booster dose of the Moderna vaccine at least six months after the initial two-shot inoculation for those aged 65 and over, people at high-risk of severe COVID-19 and individuals ages 18 to 64 at risk of frequent exposure to coronavirus infections due to their jobs. 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 at 30 micrograms.

Imunocompromised individuals would still receive a full 100 microgram dose for their third shot, as they do not respond well to the original two-dose regimen. 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.

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 https://www.reuters.com/world/us/us-cdc-advisers-recommend-covid-19-vaccine-boosters-65-older-high-risk-2021-09-23 for certain high-risk adults last month. Since then, nearly 9 million people have received a third shot, the CDC reported on Wednesday.

Data on the need for boosters has largely come from Israel, which rolled out additional shots of the Pfizer/BioNTech vaccine to large swaths of its population, and has provided details on the effectiveness of that effort to U.S. advisers. No similar real-world study populations exist for the Moderna or Johnson & Johnson vaccines.

'A BREAK IN THE EPIDEMIC CURVE' Israeli health officials told FDA advisers that the percentage of positive COVID-19 tests began to decrease nationwide after boosters were administered to most age groups.

"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, however, said it is important to remember 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. FDA staff in documents posted on Tuesday https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-seeks-covid-19-vaccine-booster-clearance-older-adults-high-risk-2021-10-12 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 in one study, particularly in those whose levels had remained high.

If a booster is authorized, Moderna said new vials would not be needed, so there should be no delay in booster availability due to packaging. In the United States, the Delta surge 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, primarily among the unvaccinated.

The FDA's advisers are scheduled to consider booster shots for J&J's single-dose vaccine on Friday.

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