FDA Vaccine Expert Group Meeting on Pfizer Booster Injections
After offering reminders to the general population, she said, Israel now has on average about half as many critically or critically ill patients as expected. She said the boosters had not only helped curb the spread of the infection, but “actually saved lives.”
Another Israeli scientist presented the panel with a new study of health records over 1.1. million people over the age of 60. He found that at least 12 days after the booster, severe illness rates were nearly twenty times lower in those who received a third injection of Pfizer compared to those who did not.
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 potentially face more than five million people. additional infections 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 shows that a third injection elicits a strong antibody immune response that matches or greatly exceeds 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, including some government officials, seemed deeply skeptical of Pfizer’s data and Israel’s analyzes. 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Krause, one of the FDA vaccine experts who wrote the medical journal, criticized Pfizer’s presentation of data that had not been peer reviewed or reviewed by the FDA, arguing that possible indoor modeling problems could underestimate the effectiveness of the vaccine.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 vaccinees.
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 as 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 cardiac myocarditis in young men who have. received the Pfizer-BioNTech vaccine. Several of them asked if it would be better to wait for a booster vaccine designed specifically to fend off the Delta variant of the virus.
Apoorva Mandavilli and Sheryl Gay Stolberg contributed reporting.