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FDA panel recommends Moderna Booster for certain groups

Some experts have questioned whether Moderna has gathered enough data on potential side effects. Regulators and scientists have been particularly concerned about the risks of heart disease, myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the lining around the heart.

In June, the FDA warned of these risks for the Pfizer-BioNTech and Moderna vaccines, and officials on Thursday cited a high risk in men between the ages of 18 and 25 who were fully vaccinated with Moderna or Pfizer-BioNTech.

A key part of Thursday’s discussion revolved around Israel’s recall campaign for the Pfizer-BioNTech vaccine. The Biden administration has followed Israel’s experience closely, as the country has a nationalized health system that allows it to closely monitor those vaccinated.

A senior Israeli health official told the committee that his government’s recall campaign had changed the course of the pandemic there. She said Israel has seen significantly lower rates of infection and serious illness among those who received a booster compared to those who did not. However, it was not clear whether other factors, such as the decline of the Delta variant, also had an effect.

Dr Mark Sawyer, professor at the University of California San Diego School of Medicine, said that although the Moderna vaccine was different, the data from Israel was compelling.

But Dr Kurilla of the National Institutes of Health questioned whether Israel’s recall campaign deserved so much credit, noting that the country’s latest drop in infection rates appeared to match previous waves of the virus.

He asked Dr Sharon Alroy-Preis, director of Israel’s public health services, if she thought a third injection of Pfizer’s vaccine would prolong protection for a long time, or if “you’ll be back in six months” for another. reminder. .

Dr Alroy-Preis noted that some vaccines provide protection for years after a booster. Whether this is true for coronavirus vaccines, she said, is “the million dollar question.”