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FDA Says Vaccine Benefits Outweigh Myocarditis Risks. Here Are the Facts

Which is more likely to put children in the hospital: COVID-19, or heart infection linked to a vaccine to prevent it?

Even as the latest wave of the pandemic subsides, the coronavirus remains more dangerous, according to experts at the U.S. Food and Drug Administration, which convened an advisory panel Tuesday to review data for the Pfizer-BioNTech vaccine for children aged 5-11; The committee voted to approve the vaccine’s license 17-1, arguing that its benefits outweigh recent concerns about rare heart-related side effects.

Carditis was the most worrisome side effect of the vaccine at the meeting and public discussions. But what exactly is it, and how likely is it to cause problems for young people?

What is myocarditis and pericarditis?

Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the tissues surrounding the heart, and scientists who describe the side effects of the vaccine tend to use them together. In children, both may cause fever, chest pain, shortness of breath or fainting, an irregular heartbeat, or a racing or palpitating heart.

Viral infections – including German measles (German measles), fifth disease and COVID-19 itself – are among the most common causes of heart disease, although these conditions are also associated with other types of infections and allergic reactions to chemicals or drugs.

On average, about 10 to 20 people develop myocarditis per 100,000 people each year, although boys – especially teenage boys – are more likely to develop these conditions than girls. Myocarditis has also been found to be more common in children who develop MERS-CoV, or MIS-C, a rare immune disorder.

How dangerous is myocarditis and pericarditis?

More severe cases can cause permanent damage to the heart, resulting in permanent arrhythmias, heart attacks or strokes, or even cardiac arrest and death. However, the vast majority of cases have mild symptoms that go away within a few weeks.
In one studyThree-quarters of vaccine-associated myocarditis cases had mild symptoms, while 3 percent were severe.

What effect do COVID-19 vaccines have on myocarditis risk?

Messenger RNA vaccines, such as those developed by Pfizer-BioNTech and Moderna, do not use viral particles, but rather cause the body to make and recognize proteins associated with the virus to stimulate an immune response. While scientists don’t yet know exactly how this response goes wrong, scientists believe that the inflammation of the heart could be caused by the immune system overreacting or incorrectly reacting to the protein.

A full-dose of two doses of the m-RNA vaccine has been shown to increase the risk of developing heart inflammation in adolescents, especially boys.

Hong Yang, senior advisor for benefit-risk assessment in the Bureau of Biostatistics and Epidemiology at the Food and Drug Administration’s Center for Biology Evaluation and Research, explained in a presentation Tuesday. Her group has tailored the risks and benefits of the vaccine at different levels of efficacy and varying rates of infection From the low in June (before the delta variable took control) to the high of the last wave in September.

The researchers found that, with current infection rates, vaccines could prevent approximately 45,800 cases of COVID-19 and about 200 hospital stays for every million children ages 5 to 11 who are vaccinated. In contrast, they estimated that about 106 additional cases of carditis and 92 hospitalizations would be related to vaccines.

But she cautioned that overall hospital figures do not give the full picture, as the average hospital stay for COVID-19 was six days, compared to just one day for vaccine-related myocarditis, and no child died as a result of vaccine-related heart infections. .

“When we compare the benefits and risks side by side, we have to keep in mind that the clinical effects of hospitalization and ICU stay duration due to COVID-19 are very different from those of vaccine-related myocarditis,” she said. . “The first case requires more extensive clinical care … then monitoring of patients later as a precaution.”

For all three age groups [5-11, 12-15, and 16-17]Obviously, the benefits outweigh the risks, Yang said.

However, Yang noted that the risk calculation may change once the epidemic is largely under control. If COVID-19 case rates drop to just 5 percent from the 9/11 rate — for example, 13 per 100,000 for children 5 to 11 and 15 per 100,000 for those ages 12 to 15 — the risks may outweigh the benefits for teens. , although not for girls.

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