
Inside the Safety Record Behind Israel’s Early Myocarditis Warning to Global Health Authorities
On February 28, 2021, Israel’s Ministry of Health alerted health authorities on both sides of the Atlantic to an emerging cardiac safety signal following the Pfizer Covid-19 vaccine.
By May 10, 2021, when the FDA expanded the emergency authorization of the Pfizer vaccine to adolescents aged 12-15, the myocarditis signal had been known for more than ten weeks, presented in updated Israeli safety-monitoring data to CDC and FDA officials, and flagged by the CDC for further examination. Yet US physicians would not receive formal CDC guidance until May 28, and the FDA warnings would come only in late June.
That timing was especially consequential. Vaccination was now being extended to younger adolescents, a population at very low baseline risk of severe Covid-19, but one in which the emerging cardiac signal was concentrated particularly among males. Parents and adolescents deciding whether to vaccinate needed to know what was already known, and what remained uncertain, about that risk.
Israel, the 'world’s laboratory' of the covid-19 vaccination campaign, sounded the warning by the end of February 2021. The CDC and EMA were warned. Pfizer received the detailed reports. Physicians and the public were left in the dark, never given the full picture. More than five years later, the record is finally public.
https://link.springer.com/article/10.1007/s40319-021-01067-5