FDA panel recommends Pfizer boosters for people over 65 or at risk

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

Dr William C. Gruber, Pfizer’s senior vice president of vaccine development, suggested that if the United States did not follow Israel’s lead, it could face more than five million infections. more per year among people who received their second dose 10 months earlier, compared to those who received the second injection five months earlier.

“Israel could portend the American future of Covid-19, and soon,” he said.

He said Pfizer data showed that a third stroke elicited a strong antibody immune response that matched or greatly exceeded the response after the second dose. The data also shows, he argued, that breakthrough infections in vaccinated Americans are more related to the vaccine’s reflux power over time than to the Delta variant.

But committee members and some government officials seemed deeply skeptical. Dr Philip Krause, one of the FDA vaccine experts who wrote the medical journal, criticized Pfizer’s presentation of data that had not been peer reviewed or reviewed by the FDA, arguing that the problems modeling in a study supporting the firm’s case were underestimated. the effectiveness of the vaccine.

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

Another CDC official, Dr Amanda Cohn, asked Israeli officials why the spread of the virus had recently intensified there, despite a large deployment of boosters. Dr Alroy-Preis said the Jewish vacation, as well as the start of the school year, contributed to what she suggested was a temporary increase in cases.

Committee members also said they were concerned about the lack of safety data in young booster recipients, as studies have shown an increased risk of myocarditis, an inflammation of the heart muscle, in young men who have received the Pfizer-BioNTech vaccine. Several have asked whether it would be better to wait for a booster vaccine designed specifically to fend off the Delta variant of the virus.