US Examines Israeli Military Data For Safety Of Pfizer COVID-19 Boosters

CHICAGO, Oct. 1 (Reuters) – U.S. health officials hope data on Israeli military personnel may help clarify the risk of heart muscle inflammation in young people who have received Pfizer / BioNTech COVID-19 booster shots – a potential factor for US regulators as they consider granting full approval to these boosters.

A disease called myocarditis has in rare cases been linked to two-dose mRNA vaccines manufactured by Pfizer (PFE.N) / BioNTech (22UAy.DE) and Moderna (MRNA.O), mainly in young men, but officials Americans are trying to better understand the risk.

“The real question that we haven’t answered yet is the safety data of an mRNA in young people vis-à-vis myocarditis,” said Dr Anthony Fauci, Chief Medical Advisor to President Joe Biden and America’s Leading Infectious Disease Expert, in a statement. telephone interview.

“The Israelis will have this data relatively soon because they are vaccinating everyone in the country, I think, from the age of 12, including their military recruits,” Fauci added.

The U.S. Food and Drug Administration in August granted full approval of the Pfizer / BioNTech vaccine for people 16 years of age and older, but the agency has yet to give full approval for its use as an injection. reminder. Instead, the FDA approved the recall of Pfizer as part of an emergency use authorization with the approval of the still pending Full Biologic License (BLA) application.

In their review of Pfizer’s request for booster injections, FDA advisers in particular denounced the lack of data on myocarditis in younger people.

Fauci said Israeli military data should help fill the information gap on the safety of mRNA vaccines, “which is one of the things the advisory committee is interested in.” Fauci said he expects data from Israeli military recruits to specifically shed light on vaccine safety among young people in the context of myocarditis.

The Biden administration had called for a massive booster campaign for all Americans in light of the evidence for the vaccine’s diminishing effectiveness over time.

In September, the FDA and the United States Centers for Disease Control and Prevention restricted the recommendation of the Pfizer / BioNTech recall to Americans 65 years of age and older, adults with underlying health conditions, and adults working in high risk professional and institutional environments. Read more

Fauci said he believes the proper regimen for mRNA vaccines will end up being two initial doses a few weeks apart, followed by a booster a few months later.

In June, the FDA added warnings to the Pfizer / BioNTech and Moderna vaccine labels regarding rare cases of myocarditis in adolescents and young adults. Read more

The FDA has granted emergency use authorization but not full approval for the Moderna vaccine as well as a single-dose Johnson & Johnson (JNJ.N) vaccine. The FDA said on Friday it would consider Moderna’s recall request at an advisory group meeting on October 14 and J&J’s recall request on October 15.

Israel’s digitized national database includes data from the country’s four health care providers, which administer the vaccines, as well as other institutions, including the military.

Fauci said U.S. officials plan to follow up with Israel’s health ministry on immunization data involving military recruits. The ministry, which regularly analyzes the data, has shared its findings on vaccine efficacy and safety with organizations such as the FDA.

A spokeswoman for Israel’s health ministry said she was not aware of any specific studies of boosters among military personnel.

Reporting by Julie Steenhuysen; Additional reporting by Maayan Lubell and Dan Williams in Jerusalem; Editing by Will Dunham

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