U.S. health officials are hoping data on Israeli military personnel can help clarify the risk of heart muscle inflammation in younger people who have received Pfizer/BioNTech COVID-19 booster shots - a potential factor for U.S. regulators as they consider granting full approval of these boosters.
"The real question that we have not yet answered is the safety data of an mRNA in young people vis-a-vis myocarditis," Dr. Anthony Fauci, President Joe Biden's chief medical adviser and the top U.S. infectious disease expert, said in a telephone interview.
The U.S. Food and Drug Administration in August granted full approval for the Pfizer/BioNTech vaccine for people age 16 and older but the agency has not yet given full approval for its use as a booster shot. Instead, the FDA approved Pfizer's booster under an emergency use authorization with approval on the full biologics license application still pending.
Fauci said the Israel military data should help address the gap in safety information on mRNA vaccines, "which is one of the things that the advisory committee was interested in." Fauci said he expects data from Israeli military recruits specifically to shed light on the safety of the vaccines in younger people in the context of myocarditis.
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