FDA Panel Recommends Moderna Booster for Certain Groups

Some experts questioned whether Moderna had collected enough data on potential side effects. Regulators and scientists are particularly concerned about the risks of the heart conditions myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the membrane around the heart.

In June, the FDA added warnings about these risks to Pfizer-BioNTech and Moderna vaccines, and officials on Thursday noted an increased risk in men aged 18 to 25 who have been fully vaccinated with either Moderna or Pfizer-BioNTech.

A significant part of Thursday’s discussion revolved around Israel’s support campaign for the Pfizer-BioNTech vaccine. The Biden administration is watching Israel’s experience closely, as the country has a nationalized healthcare system that allows it to closely monitor vaccine recipients.

A senior Israeli health official told the committee that his government’s support campaign had turned the tide of the pandemic there. He said Israel had dramatically lower rates of both infection and serious illness in those who received the booster vaccine compared to those who did not. It was unclear, though, whether other factors, such as the decline of the Delta variant, also had an effect.

A professor at the University of California San Diego School of Medicine, Dr. Mark Sawyer said Israel’s data is compelling, although the Moderna vaccine is different. “We can probably speculate from Pfizer data in Israel,” he said, as Moderna’s and Pfizer’s vaccines are “quite similar.”

But from the National Institutes of Health, Dr. Kurilla questioned whether Israel’s support campaign deserves so much praise, noting that the recent drop in infection rates in the country matches previous virus waves.

Israel’s director of public health services, Dr. Asked Sharon Alroy-Preis whether she believes the third injection of Pfizer’s vaccine will extend protection for a long time, or “will you be back in six months” for another vaccine. .

Dr. Alroy-Preis noted that some vaccines provide protection for years after the booster shot. Whether that’s true for coronavirus vaccines is the “million dollar question,” he said.

Apoorva Mandavilli Contributed to reporting from New York.

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