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According to a large new study by Israeli researchers, receiving at least one dose of Pfizer vaccine increases the risk of a rare type of heart inflammation, especially in young men. However, cases diagnosed were generally mild and most patients were discharged home without the need for continued treatment.
The disease, called myocarditis, an inflammation of the heart muscle, has been reported in a very small number of people who have received the Pfizer-BioNTech or Moderna mRNA vaccine. Symptoms may include chest pain, palpitations, and shortness of breath. Most patients who receive care recover quickly.
The study, which was published in the New England Journal of Medicine on Wednesday, only looked at people who received doses of the Pfizer vaccine. Researchers identified 54 cases of myocarditis among more than 2.5 million people aged 16 and over who received at least one dose of Pfizer vaccine. All but three occurred in men. The ages were 21 to 35, with a median of 27.
Researchers reviewed healthcare records from December through May at Clalit Health Services, the largest healthcare organization in Israel. Patients were followed for up to 42 days after the first doses of vaccine.
Overall, there were 2 cases of myocarditis per 100,000 people vaccinated. The rate was highest in male patients aged 16 to 29, with almost 11 cases of myocarditis per 100,000 people vaccinated.
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The authors noted that the rate in Israel was higher than in the United States, where the Centers for Disease Control and Prevention collects the data, most likely due to the way the data was collected. The CDC has estimated that the incidence of myocarditis after any Covid vaccination is 0.48 cases per 100,000.
The differences can be explained by different age limits and because Israeli researchers looked at medical records in a large health care system. The CDC relies on self-reported data in VAERS, a vaccine adverse event monitoring system.
“Across all age groups, the benefits still far outweigh the potential risks,” said Dr. Sean O’Leary, vice chair of the American Academy of Pediatrics Committee on Infectious Diseases, which no was not involved in the research.
He said the study was “very well done” and would help understand the real risk of myocarditis after vaccinations, especially in younger men.
“It helps us get closer to an accurate estimate of risk, but it doesn’t necessarily mean it’s the exact estimate,” he said.
Most cases after the second dose of vaccine
According to CDC data, most cases in Israel have occurred three to five days after the doses. The study did not include the third booster dose of the Pfizer vaccine, which Israel began administering over the summer.
Chest pain was the most frequently reported symptom, along with fever and shortness of breath. The median length of hospital stay was three days, with 65 percent of patients discharged home without the need for continued treatment.
Fourteen patients had problems with the left ventricle of the heart on admission; 10 were still malfunctioning when they were sent home. Subsequent tests revealed normal heart function in five of these patients.
More than three-quarters of the cases were described as mild, meaning the patients had symptoms but their heart function was normal. Another 22% with symptoms experienced an abnormality on heart tests.
There was one severe case of previously unreported cardiac dysfunction, and the patient made a full recovery with treatment. A person with a history of heart problems has died; the exact cause of death was unknown.
“The study reinforces the underlying message that most of these cases are mild,” said Dr. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescription at the University of Pittsburgh.
Gellad, who was not involved in the research, said it was very helpful in understanding the real risk of myocarditis after a Pfizer vaccine injection.
“It’s a problem primarily for adolescents and young men,” Gellad said. “It’s just a pattern repeated in every study that this is a problem after the second dose mostly for young men.”
Heart risks are higher due to Covid infection
Dr Yvonne Maldonado, a pediatric infectious disease physician at Stanford University, said it is important for people to know that the risk of myocarditis from coronavirus infection remains higher than that from Covid vaccinations.
“If you look at the risk of myocarditis, it’s much higher for people who develop Covid-19 than it is for the vaccine,” she said.
A recent study from Case Western Reserve University published online estimated that the risk of developing myocarditis from infection was six times that of vaccination in young men. The study was not peer reviewed.
Maldonado said that when speaking to families about their concerns about immunization, she tries to be as open as possible about the risks and benefits.
“We have to be transparent with families, but we also have to define, as we do with all other vaccines, what are the risks and what are the benefits,” she said. “Families always come to the pediatricians for that kind of advice. “
Gellad, a primary care provider, agreed.
“It’s a difficult question to tackle, because you don’t want to contribute to the reluctance,” he said. “On the other hand, you have to be honest with people, and honesty is often what people react to.”
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