TUESDAY, Sept. 14, 2021 (HealthDay News) – New data out of Israel, to be published this week, could bolster the notion that a third booster shot of the COVID-19 vaccine significantly lowers a recipient's odds for severe illness.
The data is scheduled to be published in the peer-reviewed New England Journal of Medicine, ahead of this week's U.S. Food and Drug Administration advisory panel meeting on booster shots, CNN reported.
Although the journal does not comment on prospective publications, Editor-in-Chief Dr. Eric Rubin said the journal moves quickly to review data that can impact public health. The FDA also does its own internal review of data, he said.
"If we are able to inform a public discussion, then we will work rapidly to do that," Rubin told CNN.
Preliminary data from the Israeli Ministry of Health — not yet peer-reviewed — was posted last month on a pre-print server. In that analysis, more than one million Israelis over the age of 60 received boosters between July 30 and August 22.
The risk of severe illness decreased more than 10-fold and the relative risk of confirmed infection decreased more than 11-fold a dozen days after people got their third dose of the vaccine, according to the data.
Israel has given boosters to about 2.8 million of its people so far.
The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet on Sept. 17.
Publication of the Israeli data in the New England Journal of Medicinemeans that it will have undergone the rigorous peer-review process.
Having peer-reviewed data published in a prominent medical journal would be helpful to members of the committee, said Dr. Paul Offit, an infectious disease specialist at the University of Pennsylvania and a member of the advisory committee.
"That's always true — we would prefer independent reviewers look carefully at every piece of evidence and have their criticism and shape their revisions," Offit said.
Offit and others have asked for more data on booster effectiveness, CNN reported. The U.S. Centers for Disease Control and Prevention also would need to give the green light to any rollout of booster shots.
The White House has been criticized for announcing that boosters could begin to roll out to eligible people beginning Sept. 20, before the FDA and CDC have contributed to the discussion.
Peer review in the New England Journal of Medicine"is really important," one senior CDC official working on the COVID-19 response told CNN. "They critically review the paper and correspond with authors for explanation and clarification. I absolutely think that will make a difference."
Dr. Nachman Ash, director general of the Israeli Ministry of Health, told CNN that 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 the data at the FDA advisors meeting.
Ash said the New England Journal of Medicine will also be publishing a second set of Ministry of Health data before the FDA advisers meet. That study showed that people over age 60 who received their second dose of the vaccine in March were 60% more protected against infection and 70% more protected against severe COVID-19 compared to those who received their second dose in January, CNN reported.
News of the Israeli data's imminent publication comes on the heels of a large international review that did not support the need for boosters at this time.
The review — conducted by a team that included scientists from the World Health Organization (WHO) and the FDA — concluded that current vaccines are effective enough against severe COVID-19, even from the Delta variant, and that booster shots are unnecessary.
The findings, published Sept. 13 in The Lancet, are based on a review of all available published literature and results of clinical trials.
"The vaccines that are currently available are safe, effective, and save lives," said study co-author Dr. Soumya Swaminathan, chief scientist at the WHO.
The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccines and the booster question.
SOURCES: CNN, The Lancet