FDA advisory panel recommends Pfizer boosters for the elderly and others at high risk

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After offering boosters to the general population, she said, Israel now had on average about half as many seriously or critically ill patients as expected. She said boosters not only helped curb the spread of infection but “really saved lives.”

dr. William C. Gruber, a senior Pfizer vice president in charge of vaccine development, suggested that if the United States does not follow Israel’s lead, it could face more than five million additional infections per year among humans. who received their second dose 10 months earlier, compared with those who received the second injection five months earlier.

“Israel could predict the future of Covid-19 in the US, and soon,” he said.

He said Pfizer’s data showed that a third injection elicited a robust immune response equal to or much greater than the response after the second dose. Evidence also shows, he argued, that breakthrough infections among vaccinated Americans are more related to the declining potency of the vaccine over time than to the Delta variant.

But committee members and some government officials seemed highly skeptical. dr. Philip Krause, one of the FDA vaccine experts who wrote the review of medical journals, criticized Pfizer’s presentation of data that had not been peer-reviewed or evaluated by the FDA, arguing that the modeling issues in a study investigating the case of the company was substantiated, understated. the efficacy of the vaccine.

dr. Oliver, the CDC official, questioned attempts to draw a parallel between the United States and Israel, noting that Israel has only nine million inhabitants and is less diverse than the United States. Notably, she also said Israel defines a severe case of Covid-19 more broadly than the United States, which could help explain why Israel is reporting more severe breakthrough infections among its vaccinated residents.

Another CDC official, Dr. Amanda Cohn, asked Israeli officials why the spread of the virus had increased there recently, despite a wide rollout of boosters. dr. Alroy-Preis said the Jewish holidays, along with the start of the school year, contributed to what she suggested would temporarily increase the number of cases.

Committee members also said they were concerned about the lack of safety data in younger booster dose recipients, as studies have shown a higher risk of myocarditis, an inflammation of the heart muscle, in young men who received the Pfizer-BioNTech vaccine. Several asked whether it would not be better to wait for a booster vaccine that has been specially developed to ward off the Delta variant of the virus.

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