Large Israeli study: risk of heart inflammation after COVID injections is very minor



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A new Israeli study has found that the risk of heart inflammation from Pfizer’s coronavirus vaccine is extremely low and perfectly treatable.

A link has been observed in recent months between coronavirus vaccines using mRNA technology and very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart).

Research by Israel’s largest healthcare provider, Clalit, with Beilinson Medical Center, and published in the New England Journal of Medicine on Wednesday, looked at data from 2.5 million vaccinated Israelis, including 94% had received two doses of the vaccine.

He found that cases of such inflammation occurred in 54 people (51 men, three women) or 2.13 out of 100,000 vaccinated (about two thousand percentage points). Of these, 98 percent of cases were mild (76%) to moderate (22%) and caused no damage to heart function. According to the study, only one in 2.5 million people had a serious case that required hospitalization and recovered.

When it does occur, the side effect of heart inflammation has been seen particularly in young men after their second dose. The new study confirmed this, with 69% of cases occurring after the second injection, mostly in men and mostly in the 16-29 age group (where the prevalence of cases was 10.7 per 100,000).

“This study is the first to allow a credible assessment of the incidence of myocarditis,” said researcher Dr Guy Witberg of Beilinson. “The results show that this is a relatively rare event, even in the highest risk population – young men.”

An Israeli receives a dose of the COVID-19 vaccine in Jerusalem, September 26, 2021 (Olivier Fitoussi / Flash90)

Ran Kornowski of Beilinson added that the results were “significant”, adding that he hoped they would help decision-making on the vaccine, which he said had “shown enormous benefits in preventing the disease. coronavirus disease and its many consequences “.

U.S. health officials have turned to data from Israel to help shed light on the safety of Pfizer / BioNtech’s COVID-19 booster injections in young people, and the risks of developing myocarditis.

Last Friday, U.S. Chief Medical Advisor Dr.Anthony Fauci, America’s foremost infectious disease expert, told Reuters that a key unanswered question was “the safety data of an mRNA in young people with myocarditis “.

“The Israelis will have this data relatively soon because they are vaccinating everyone in the country, I think, from the age of 12, including their military recruits,” Fauci said. He added that the data could “help fill the information gap on the safety of mRNA vaccines,” according to the report.

Israel’s health ministry released data on Friday showing that known side effects from COVID-19 vaccines were significantly milder after the booster compared to the first two doses. Reported side effects, such as fatigue, weakness and pain in the arm where the injection was given, were all less common the third time around in all age groups, according to the ministry.

Of some 3.2 million Israelis vaccinated with a third injection of COVID-19, only 19 reported more serious side effects, the ministry said, adding that some are still being examined by experts to determine the link between side effects and vaccine.

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks with reporters at the White House in Washington, January 21, 2021 (AP Photo / Alex Brandon, File)

Separately, the ministry also released data on reported cases of myocarditis in people aged 12 to 15 who had received their first and second doses of COVID-19 vaccine, saying the disease had been observed at a “rate insignificant ”.

One case was reported out of 331,538 children vaccinated with one dose of the vaccine. The boy was identified with the inflammation five days after receiving the blow, according to ministry data. And among the 255,444 children vaccinated with two doses, 11 cases of myocarditis were reported. Ten of them were men and one was a woman. They were identified with the rare disease 3 to 5 days after receiving the vaccine, the ministry said.

The ministry said the 12 were released from hospital care to be treated at home and the disease itself disappeared soon after. He added that the risks of suffering from myocarditis are less likely in older age groups and almost negligible in women.

Fauci told IDF Radio he believed there would soon be “good safety data” on young people receiving the third dose.

“That’s why I watch very closely when Israel obtains its security data from young people,” he said.

“There is great concern about the risk-benefit ratio of younger people in the context of myocarditis,” said Fauci. “We know this is a very rare event and we know the Israelis are starting to put together a tremendous amount of data that will actually give us a good overview of the risk, especially in vaccinating young people in your military. “

Israel has made vaccination the cornerstone of its efforts to curb a major resurgence of viral infections after reducing the number of daily cases in June to just over a dozen.

While research suggests that immunity levels in those who have been vaccinated decline over time – an effect that can be reversed with boosters – the Pfizer-BioNTech vaccine is still very protective against serious illness and death, even. amid the spread of the highly contagious Delta variant.

Agencies contributed to this report.

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