Israel, Pfizer face fresh scrutiny over early COVID vaccine heart safety reports

A peer-reviewed study has raised fresh questions about how early reports of serious adverse events following administration of the Pfizer-BioNTech COVID-19 vaccine were handled by Israel’s Ministry of Health and pharmaceutical manufacturer Pfizer.

The study, published in the EXCLI Journal, examined Israeli Ministry of Health records documenting hospitalisations and deaths reported between March 2021 and May 2022. Its findings have prompted debate over vaccine safety monitoring, public disclosure and the adequacy of information provided to patients and medical professionals.

According to the study, researchers reviewed 531 hospitalisation records, including 67 deaths. Nine of the deceased patients were below the age of 50, while two deaths were attributed to myocarditis, an inflammation of the heart muscle that can, in severe cases, lead to serious cardiac complications.

The researchers reported that 211 of the hospitalisation records with valid age information involved patients below 30, representing 39.8 per cent of the total. Myocarditis or pericarditis was identified in 250 records, including 151 cases involving patients under 30.

Among the younger patients, 134 reportedly had no significant medical history before their hospitalisation. Of those, 99 were diagnosed with myocarditis or pericarditis, with males accounting for 90 cases.

The study also identified a 22-year-old woman and a 47-year-old man whose deaths were attributed to myocarditis. Another record involving a 35-year-old man cited worsening heart failure but did not specifically mention myocarditis.

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The authors said the records were reported to Pfizer and the Israeli Ministry of Health during 2021 and 2022. They argued that the relatively short intervals between vaccination and the onset of some injuries, together with detailed clinical documentation, warranted closer scrutiny.

The study further alleged that information about the reported cases was not made public promptly. It cited previous reports indicating that Israeli authorities had identified myocarditis cases among vaccinated individuals as early as January 2021.

The researchers also referred to communications involving United States health authorities, claiming that concerns raised about myocarditis in Israel were not publicly acknowledged as a safety signal until later in 2021.

However, the study’s findings concern reported adverse events and do not, by themselves, establish that vaccination caused every hospitalisation or death documented in the dataset.

Beyond myocarditis and pericarditis, the records reportedly included cases involving cardiac arrhythmias, fainting, heart failure, seizures, stroke, encephalitis, Guillain-Barré syndrome, suspected anaphylaxis and other inflammatory or neurological conditions.

The authors said the data could have implications for clinical awareness and informed decision-making, particularly where patients needed information about potential risks before receiving additional vaccine doses.

The study also raised questions about changes made to the Ministry of Health dataset over time. According to the researchers, later versions added or revised clinical information and omitted some records. They said the absence of a formal audit trail made it difficult to determine why those changes occurred.

The findings have attracted criticism from vaccine-safety advocates, who argue that health authorities should provide greater transparency concerning adverse-event reports.

Karl Jablonowski, a senior research scientist at Children’s Health Defense, questioned why some reported deaths were not reflected in the United States Vaccine Adverse Event Reporting System. Steve Kirsch, founder of the Vaccine Safety Research Foundation, also called for greater accountability over the handling of the Israeli data.

Meanwhile, Dr Jane Orient of the Association of American Physicians and Surgeons argued that the findings reflected wider failures in vaccine-risk communication.

The study’s publication is likely to fuel continuing debate over the safety of mRNA COVID-19 vaccines. Nevertheless, determining whether the reported events were caused by vaccination requires comprehensive epidemiological investigation, comparison with background rates and independent review of the underlying medical records.