Israel’s Health Ministry confirms probable link between myocarditis, Pfizer vaccine

Israel’s Ministry of Health has confirmed a connection between myocarditis – inflammation of the heart muscle – and the Pfizer vaccine, after dozens of cases were found in young men, ages 16 to 30.

“There is a probable link between receiving the second dose (of Pfizer) vaccine and the appearance of myocarditis among men aged 16 to 30,” the ministry said in a statement.

But because the cases are “mild,” the vaccine was declared “safe and effective,” according to the Ministry of Health and, starting next week, will likely be made available to Israeli adolescents. The ministry said the risks of unvaccinated adolescents suffering from severe coronavirus and post-corona symptoms outweighs the risks of possible side effects of the vaccine.

However, an epidemiological team has concluded that between one in 3,000 and one in 6,000 men ages of 16 to 24 who received the vaccine developed the rare condition.

Between December – when the vaccination campaign began – through May, some 275 people who took the vaccine were diagnosed with myocarditis, 148 of them around the time they were vaccinated. Some 90% of these patients were young men.

Most cases were mild, with patients released from the hospital after four days, the report found, as is usual with myocarditis.

Two healthy young people – a 22-year-old woman and a 35-year-old man – both died of cardiac arrest, but the Ministry of Health could not prove those cases were connected to the vaccine.

Israelis adopted the government’s massive and lighting-fast vaccination campaign starting on Dec. 20. It was met with the enthusiasm and vast compliance of the public and is widely credited for the sharp drop in cases over the past few months. More than 5 million residents, 16 and up, have been fully dosed with the Pfizer injection. At the same time, only a few dozen people are diagnosed with COVID on a daily basis and the number of serious cases nationwide has dropped below 50 – down from more than 1,200 in January.

However, there is less excitement in the country when it comes to vaccinating children with the virus appearing to have been stamped out in Israel and, in most cases, children who do contract COVID-19 have light to non-existent symptoms. Also, with nearly all of Israel’s COVID restrictions having been dropped as of Tuesday, children are now allowed to enter venues previously banned to the unvaccinated and non-recovered.

As opposed to the adult population, resistance to vaccinating children is expected to be much higher. More than 100 Israeli doctors have already registered their opposition and some parents are calling for a strike from school on Sunday to coincide with a protest in front of the home of Health Ministry Director-General Chezi Levy.

There had been talk of vaccinating children at school and using peer pressure to convince more children to get the injection, but no final decision has been made.

The Public Emergency Council for the Coronavirus Crisis, in an open letter to the health ministry, said an immediate halt to vaccinations is the “ethical” thing to do at this point.

“While this may not be clear to people in the general public, it is clear to you and us, the undersigned, that the absence of a clear connection at this stage does not negate the existence of the connection, and certainly not its clinical significance,” the council wrote. “In addition, there is a serious ethical error in trying to downplay the importance of myocardial pathology, as if it were a morning cold. It is also clear to you that this is a clinical disorder with a life-threatening potential (certainly by several orders of magnitude greater than the risk of corona in children), which can cause arrhythmias, future damage to the heart to the point of cardiomyopathy and even death.”

Children in the 12- to 15-year-old age group account for about 2.3 million of the 9.2 million population.

The rise in cases of myocarditis is not limited to Israel. Last month, the U.S. Centers for Disease Control and Prevention and the European Medicines Agency also reported rising cases and the CDC recommended further study of a possible link between heart muscle inflammation and the mRNA vaccine.

Douglas Diekema, a Seattle pediatrician, told Science that even if a link is found between the vaccine and myocarditis, he believes vaccination is preferable since the condition usually can be treated, whereas COVID-19 could cause serious long-term side effects.

Myocarditis is inflammation of the heart muscle which affects the organ’s ability to pump blood. The condition is usually mild, but can result in heart failure, permanent heart damage and even death if left untreated. Myocarditis sometimes has no indications, but those who do experience symptoms may have shortness of breath or chest pains among other issues. The condition is usually caused by a viral infection.

The Science article said that though the numbers do not appear too alarming, 90% of the cases in Israel appeared in men, and of those “the rate among those vaccinated was somewhere between five and 25 times the background rate, the report says. (Two cases of fatal myocarditis have also been reported in Israel, but the panel says investigations of those deaths were inconclusive; one patient may have had a more generalized inflammatory syndrome, and the other diagnosis was ‘not verified,’ the report says.)”

Dror Mevorach, head of internal medicine at the Hadassah University Medical Center, who led Israel’s research team said it could be the mRNA in the vaccine that is triggering these responses.

Pfizer said in a statement that it is aware of the Israeli study and noted that a direct link to the vaccine has not been established.