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Israel began its recall program on August 1, giving reminders to 2.8 million people so far. To date, most of the country’s data on the effectiveness of booster injections has not been reviewed by external experts and published in a medical journal.
Publishing peer-reviewed data in a leading medical journal would be helpful to members of the FDA’s Vaccines and Related Biologics Advisory Committee when they meet on September 17, a longtime committee member said. .
“This is still true – we would prefer independent reviewers to carefully review each piece of evidence, have their critiques and shape their reviews,” said Dr. Paul Offit, infectious disease specialist at the University of Pennsylvania and committee member. .
The United States Centers for Disease Control and Prevention must also approve all recalls.
“The peer review is really important. They are reviewing the document critically and corresponding with the authors for explanation and clarification,” said a senior CDC official working on the Covid-19 response. “I absolutely think it will make a difference.”
Offit and others have called for more data on the effectiveness of boosters, as President Joe Biden’s administration has come under fire for cutting edge science by announcing a specific date – the week of September 20 – when the boosters would begin. , even before the FDA and the US Centers for Disease Control questioned whether the US should launch a recall campaign.
Dr Sharon Alroy-Preis, director of public health services at the Israeli Ministry of Health, and Ron Milo, professor at the Weizmann Institute of Science, will present the data next week at the FDA advisers meeting, a Ash said.
Data from Israel’s health ministry, released on a pre-print server last month, covers more than one million Israelis over 60 who received a recall between July 30 and August 22. the booster was given, the relative risk of serious illness decreased by more than ten times and the relative risk of confirmed infection decreased by more than 11 times.
The New England Journal of Medicine does not comment on potential publications, said Dr. Eric Rubin, editor of the journal.
He noted that the FDA conducts its own internal review of the data and that its journal is timely reviewing data that may improve public health.
“If we are able to inform a public debate, then we will work quickly to do so,” he said.
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