Heart Problem More Common After Covid-19 After Vaccination, Study


The Pfizer-BioNTech Covid-19 vaccine is associated with an increased risk of myocarditis, an inflammation of the heart muscle, confirms a large new study from Israel. However, side effects are rare and Covid-19 is more likely to cause myocarditis than the vaccine. scientists have reported Wednesday.

Based on the electronic health records of nearly two million people aged 16 years or older, the research provides a comprehensive look at the real-world incidence of various adverse events after both vaccination and infection with the coronavirus.

Although the work is intact myocarditis risks By age or sex, the researchers reported that the median age of people who developed the condition after vaccination was 25, and 19 of the 21 cases were men.

In addition to myocarditis, the Pfizer vaccine was also associated with an increased risk of swollen lymph nodes, appendicitis and shingles, although all three adverse events remained rare in the study. Coronavirus infection was not associated with these side effects, but increased the likelihood of potentially serious cardiovascular problems, including heart attacks and blood clots.

“The coronavirus is very dangerous and in many ways very dangerous to the human body,” said Ben Reis, co-author of the new study and director of the predictive medicine group at Boston Children’s Hospital Computational Health Informatics Program.

“If the reason someone has been hesitant to get vaccinated until now is because they fear this very rare and usually not very serious adverse event called myocarditis, this study shows that the same adverse event is actually associated with a disease with a higher risk if you have not been vaccinated and become infected.

The data came amid an intense debate among federal regulators about the risks of myocarditis and pericarditis, an inflammation of the membrane around the heart, in younger recipients of both Pfizer-BioNTech and Moderna vaccines. The Food and Drug Administration will negotiate larger pediatric studies with vaccine manufacturers this summer in hopes of adequately assessing the risks before a possible emergency clearance for young children. Companies are working on lower doses in children to mitigate some of the risk.

In their review of the Pfizer-BioNTech vaccine, regulators paid close attention to an American healthcare claims database that found that the risk of disease in vaccinated boys aged 16 and 17 may be as high as 1 in 5,000. Cases in database not confirmed, FDA warns in an analysis published this week, but they were considered a reasonable estimate of possible risk. The analysis said that even in the worst-case scenarios of post-vaccination myocarditis and pericarditis modeled by the FDA, the benefits of vaccination still outweigh the risks.

The study was one reason why the FDA said that after the Pfizer-BioNTech vaccine was licensed this week, Pfizer said it would be conducting studies on the risks of myocarditis and pericarditis, including the risks of myocarditis and pericarditis in those vaccinated, and the long-term consequences for those who get sick after the vaccine.

Israel’s vaccination campaign, based on the Pfizer vaccine, got off to a quick start; By May 24, nearly five million people, or roughly 55 percent of the country’s population, had received both doses of the vaccine.

The new study, published in the New England Journal of Medicine, is based on an analysis of electronic health records from Clalit Health Services, the nation’s largest HMO.

A group of researchers Approximately 880,000 people aged 16 and over vaccinated by 24 May. To create a control group, they matched each of these individuals with a medically and demographically similar unvaccinated person.

Clalit Health Services chief innovation officer and lead author of the new study, Dr. “You can think of them as false twins,” said Ran Balicer.

The researchers then calculated the incidence of 25 different potential adverse events in each group. In a second round of analysis, they calculated the incidence of the same potential side effects in a group of 170,000 people who tested positive for coronavirus and a similar uninfected control group.

They found that although myocarditis is rare, it was more common in the vaccinated group than the unvaccinated group. The researchers found that for every 100,000 people in the vaccinated group, there were 2.7 extra cases of myocarditis compared to the unvaccinated.

But the risks were even higher among those who contracted the virus. For every 100,000 people infected with the coronavirus, there were 11 extra cases of the condition, compared to those who were not.

Saying that he is considering calls from parents who are concerned about the risk of myocarditis and who specializes in heart inflammation in children at UPMC Children’s Hospital in Pittsburgh, Dr. Brian Feingold said the study provides a critical context for understanding the risks and benefits of vaccination.

“And nobody blows it up, but I think you just have to look at it in context,” he said. “The risks associated with Covid are higher than those associated with vaccines.”

In addition to myocarditis, coronavirus infection has also been associated with an increased risk of heart attack, irregular heartbeat, blood clots in the lungs or legs, kidney damage, and bleeding inside the skull. For every 100,000 infections, for example, there were an additional 25 cases of heart attacks and 62 blood clots in the lungs.

“When you’re trying to decide whether or not to get vaccinated, one of the things to ask is not only what the possible side effects of getting vaccinated are, but also what I’m risking when I think about Covid-19 as an alternative,” said Dr. Balicer.

The scientists said that while the study is reassuring, it’s important to continue collecting data on the risks of myocarditis, especially in younger men.

A pediatric infectious diseases specialist at the University of Colorado Anschutz Medical Campus, Dr. “But we are in this hot moment,” said Sean O’Leary. “That’s what we’ve got, and the benefits still seem to far outweigh the risks.”

Inside a new studyThe researchers calculated that 12- to 17-year-old boys were about six times more likely to develop myocarditis after being infected with the virus after receiving one of the mRNA vaccines.


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