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.
The warning came just over two months after Israel had launched one of the fastest vaccination campaigns in the world, placing the country at the forefront of the global rollout.
That day, the Ministry informed the European Medicines Agency that it was investigating a “safety signal of myocarditis/peri-myocarditis in the younger population (16–30 years old)” and had already received reports of around 40 cases. A CDC internal tasking memo from the same day recorded that Israel was seeing “a large number of reports of myocarditis, particularly in young people,” and was seeking contacts at the CDC and FDA to discuss the issue. The message was marked “Importance: High.”
Three days later, Dr. Roee Singer, Deputy Director of Epidemiology at Israel’s Ministry of Health, wrote directly to the CDC: “We are seeing a large number of myocarditis and pericarditis cases in young individuals soon after Pfizer COVID-19 vaccine. We would like to discuss the issue with a relevant expert at CDC.”
It was, in every sense, a “Houston, we have a problem” moment.
The alarm had been sounded. But what, exactly, had Israeli health officials seen that prompted it? And when, and how, was that warning communicated to physicians and the public?
Our newly published study in EXCLI Journal discloses and analyzes an internal Israeli Ministry of Health pharmacovigilance dataset that had never been made public. The dataset was provided to us by a whistleblower whose identity we are protecting. The file itself was titled, in Hebrew, “Reports of Hospitalizations and Deaths to Pfizer,” and contains detailed case-level reports documented by the Ministry of Health during the vaccination campaign.
The record was not reconstructed years later, after vaccine-associated myocarditis had become an established safety concern. It was being built in real time as the signal emerged.
The dataset provided to us comprised eight cumulative versions, all sharing an original creation date of March 25, 2021. The record was updated repeatedly for more than a year as new cases were added and existing reports were revised with additional clinical information. The final version extends through May 9, 2022.
Already on March 25, just over three weeks after Israel first sounded the international alarm, the record contained 157 hospitalization reports and 46 death reports. Sixty-five of the hospitalization reports involved myocarditis or pericarditis.
By the final version of the dataset, myocarditis or pericarditis appeared in 250 of 531 hospitalization reports, nearly half. Among patients under 30, it appeared in 151 of 211 reports, more than 70%.
Hellbound and Down 