Israel began its reinforcement program on August 1, giving so far 2.8 million people. To date, much of the country’s data on the effectiveness of booster shots has not been reviewed by external experts and published in a medical journal.
Paired peer-reviewed data in a prominent medical journal would be helpful for members of the FDA’s related vaccine and biological products advisory committee when they meet Sept. 17, a committee member said.
“It’s always true: we’d rather have independent reviewers carefully analyze all the evidence and receive their criticism and shape their reviews,” said Dr. Paul Offit, an infectious disease specialist at the University of Pennsylvania and a member of the committee.
U.S. Centers for Disease Control and Prevention must also sign any reinforcing features.
“The peer review is really important. They critically review the paper and correspond with the authors for explanations and clarifications,” said a senior CDC official working on the Covid-19 response. “I absolutely believe this will make a difference.”
Offit and others have called for more data on the effectiveness of the reinforcement, as the administration of President Joe Biden has been criticized for advancing science by announcing a specific date (the week of September 20) that the promoters would begin, even before the FDA and the U.S. Centers for Disease Control weighed in on whether the U.S. should begin a strengthening campaign.
Dr. Sharon Alroy-Preis, director of public health services at the Israeli Ministry of Health, and Ron Milo, a professor at the Weizmann Institute of Science, will present data next week at the FDA advisory meeting, Ash said .
Data from the Israeli Ministry of Health, published last month on a prepress server, analyzes more than one million Israelis over the age of 60 who received reinforcements between July 30 and August 22. It was found that 12 days or more after reinforcement was given, the relative risk of serious illness decreased more than ten times, and the relative risk of confirmed infection decreased more than 11 times.
The New England Journal of Medicine does not comment on possible publications, said Dr. Eric Rubin, editor-in-chief of the journal.
He noted that the FDA does its own internal review of data and that its journal moves in time to review data that could improve public health.
“If we can report a public discussion, we will work quickly to do so,” he said.