Israeli health officials have found a probable link between the Pfizer/BioNTech COVID vaccine — which the country has relied on almost exclusively in its vaccination drive — and dozens of cases of heart inflammation in young men following the second dose.
The preliminary findings of the Israeli panel studying a possible link between the vaccine and myocarditis were first leaked by Channel 12 at the end of April. Channel 12 mentioned two cases of people succumbing to the disease, but said there was no certainty as to the link between these cases and the vaccine.
After the ministry received reports of heart inflammation, including myocarditis, following recent COVID vaccination, a panel of experts was appointed to investigate the issue.
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The panel included public health experts specializing in epidemiology, members of the National Center for Disease Control and academics from the Tel Aviv University, Technion-Israel Institute of Technology and Haifa University.
Myocarditis is inflammation of the heart muscle that can lead to cardiac arrhythmia and death.
According to a study by Israeli health officials, there were 275 cases of myocarditis identified between December 2020 and May 2021, including 148 cases that occurred within a month after vaccination. Of those 148 cases, 27 occurred after the first dose and 121 after the second dose.
Many of the cases were reported among men 16 to 30, and most often in 16- to 19-year-olds. Most of the patients were discharged from the hospital in less than four days, and 95% of the cases were considered mild.
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“There is a likelihood of a connection between receiving a second dose of vaccine and the onset of myocarditis in young men aged 16-30,” the group of experts concluded. “The connection is stronger in young people aged 16-19 compared to other ages and it decreases as age increases.”
The new analysis “is very suggestive of a causal nature” between the vaccine and myocarditis, said Dror Mevorach, head of internal medicine at the Hadassah University Medical Center who was tasked with leading the panel. “I am convinced there is a relationship.”
Douglas Diekema, a pediatrician and bioethicist at Seattle Children’s Hospital, said it’s important to investigate “even a hint of a signal.” However he cautioned that “while this report is suggestive … it requires validation in other populations by other investigators before we can be certain the link exists.”
In a statement, Pfizer said there is still no indication the cases are due to its vaccine. Myocarditis is often caused by viral infections, and COVID infections have been reported to cause the condition, the drugmaker said.
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Pfizer’s partner, BioNTech, said more than 300 million doses of the COVID vaccine have been administered globally and the “benefit-risk profile” of the vaccine remains positive.
The Israeli panel’s findings come as Israel and many European countries debate whether younger adolescents should be vaccinated against COVID. A decision to include the 12 to 15 age group in the country’s vaccination program has not yet been made.