‘When I told Pfizer about incidents of myocarditis they refused to believe me for four months’

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An article published in the New England Journal of Medicine by Prof. Dror Mevorach, head of the internal medicine department at Hadassah University Hospital, Ein Karem, has aroused much interest worldwide, in the wake of a gut feeling that he had.

It happened when a healthy young man arrived in his department with myocarditis, an inflammation of the heart muscle, just one day after having received a vaccination against the coronavirus. Mevorach asked himself if this was merely a coincidence, and set out to investigate the matter internally, at Hadassah. He found two more instances of similar inflammation in newly vaccinated individuals at the hospital. This led him to develop a serious suspicion of a link between the two. Mevorach then began phoning colleagues at other hospitals in Israel, as well as the director general of the Health Ministry.

Ministry officials did not take the matter lightly, and appointed Mevorach to head up a team of inquiry. The team sent letters to every internist and cardiologist in Israel, asking them if they had come across any instances of myocarditis occurring soon after vaccination. “Within two months,” he now says, “one hundred such cases were logged.”

Mevorach’s gut feeling, which was aroused after seeing a single patient, led to the discovery of the most serious side effect that has been attributed to the Pfizer coronavirus vaccine – an increase in the frequency of myocarditis. “When I told Pfizer about it,” he told TheMarker earlier this week, “they refused to believe me for a period of four months. Only after we asked for reports on all of the cases of myocarditis in Israel, which we analyzed and were then able to statistically prove that the incidence of myocarditis doubled in the wake of receiving the vaccination, only then did Pfizer accept the findings.”

A pharmacist prepares a children’s dose of the Pfizer COVID-19 vaccine in Lawrence, Mass. this month. Charles Krupa /AP

Mevorach’s success in identifying the serious side effect has earned him a global reputation, but has also induced melancholy thoughts – since the serendipitous discovery was made thanks only to Mevorach’s gut feeling. “It depended on one individual who happened to care,” he said. “There is nothing methodological going on here.”

Other side effects

The discovery of increased risk of myocarditis has been the most significant contribution of the health system in Israel to the diagnosis of the side effects of the vaccines. Another side effect that was discovered in Israel is that of partial paralysis (paresthesia) of facial muscles. But that is where our contribution ends.

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The vaccine’s other side effects, the majority of them more minor, have been brought to the attention of the Israeli health establishment only from reports amassed elsewhere in the world. One condition that recently received official recognition in the medical research is that of delayed onset of women’s menstrual periods.

In other words, Israel has taken on the role of supporting player in the amassing of information on possible side effects of the vaccines. This, in spite of two enormous relative advantages that it has. First, Israel was the first country in the world to implement mass vaccinations among a majority of its population, and was therefore supposed to be the first country in which side effects would come to light.

The coronavirus ward at Jerusalem’s Shaare Zedek Medical Center. Emil Salman

Secondly, Israel is the only country that possesses computerized databases that collect data on the health status of millions of people – the “big data” of the health maintenance organizations. If there was one country in the world that was well placed to discern irregularities related to health-related phenomena solely by conducting statistical analyses of its health data systems, it was Israel.

The most recent report of the Health Ministry on side effects induced by vaccinations dates to September 25. By that date, the Health Ministry had received 1,664 reports of minor side effects and 25 reports on serious events (i.e., requiring urgent treatment or life-threatening). All told, the Health Ministry was tracking 25 serious side effects, of which seven were related to myocarditis and were described as being “assumed side effects,” three that were described as “possible” (including encephalitis, blurred vision and Guillain-Barr? syndrome), and two (stroke, ventricular fibrillation) were described as being “under investigation.” Any connection linking the rest of the side effects with the vaccine was ruled out by the Health Ministry.

All of the reports on side effects reached the Health Ministry by way of a reporting system that was operated by the doctors themselves, mainly a special-purpose email system that the doctor has to enter in order to report to the Health Ministry on any phenomenon that he or she suspects may be vaccine-related. The system is voluntary, in two respects: The patient has to present him or herself before the doctor and report on what they are feeling, and additionally, the doctor has to then voluntarily complete the form. How many doctors did so? No one knows.

A spokesperson for Maccabi Healthcare Services explained that their system automatically forwards the form to every physician, as soon as he or she reports a side effect that has previously been identified as being linked to the vaccine. Other HMOs explained that it totally depended on the good will of the physician, and they estimate that most of them do not fill out the form. Why? Because it is a bother, because most of the side effects are minor, because the physicians are loaded down managing a pandemic, and maybe also because the system is in self-defensive mode. In other words, it is afraid that reports of side effects will provide anti-vaxxers with more ammunition.

In practice, the reporting system depends solely on the good will of both the patients and the doctors. Evidently, the response to it in Israel has been lacking. Evidence of that is the insubstantial number of reports – less than 1,700 – despite over six million people in Israel having been vaccinated to date.

A vaccination center in the city of Kfar Saba, central Israel. Avishag Shaar-Yashuv

All told, Israeli physicians filed fewer than 1,700 reports, in sharp contrast with physicians in Britain, who filled a 108-page book with their reports. It seems that the majority of the phenomena reported upon in the British book are unrelated to the vaccine, and a research study released this week supports this contention: It revealed that most of the symptoms that appeared following vaccination were related to the nocebo effect – a detrimental response of the body caused by expectations of a side effect to a treatment. Nocebo strengthens the evaluation that a majority of the reports in Britain are not of concern. At the same time, it is clear that among the British, an effort is being made to gather reports and to analyze them, while no such effort is discernible in Israel, despite its having the finest public health system of its type in the world.

Minor symptoms dismissed

The sole and most important exploitation of the Israeli “big data” has been the examination of suspicions of side effects that have been reported, most of them from elsewhere in the world. One study conducted by Prof. Ran Balicer, the chief innovation officer at Clalit Health Services, examined 25 suspected side effects of the vaccine.

Balicer used Clalit’s database, which is the largest of its type in the world, in order to conclude that only 4 of the 25 were statistically significant: myocarditis, swelling of the lymph glands, herpes zoster (shingles) and also appendicitis. The study, which was also published in the New England Journal of Medicine, testifies to the immense importance of the HMO’s databases, and the tremendous contribution that they could make toward identifying or ruling out side effects of the vaccines.

The most significant finding in Balicer’s article is that the frequency of the majority of the suspected side effects, including myocarditis,

is much greater among coronavirus patients than among vaccinated individuals. Balicer’s article proves that the Israeli health system did not downplay the reports of severe side effects. They were investigated in depth. At the same time, the system did not go out of its way to collect reports on side effects, and most certainly did take lightly the reports on minor side effects, such as delayed menstrual periods. Evidently this was part of the general approach taken by the public health system, which is not service-oriented and does not get overly excited about minor symptoms, even during routine times.

One Israeli HMO responded to TheMarker’s queries on this matter quite directly: “We did not analyze the side effects”; “We did not conduct searches of our big data. When the pandemic subsides and there will be time, we will deal with that, too”; “During a pandemic, when vaccinations are being administered, the physician deals mainly with significant complications and long-term damage.”

The strengths and weaknesses of Israel’s health system were reflected in its attitude toward vaccinations: a lack of empathy for patients’ complaints, disregard and non-methodological care for what it sees as “trifles,” and, on the other hand, serious regard for life-endangering events. The health system did take note of dangerous side effects, but missed out on winning the trust of the public, which sensed this disregard toward reports of side effects. In so doing, Israel’s health system itself provided free ammunition to the anti-vaxxers.