Moderna’s Covid vaccine for teens awaits approval as regulators review heart inflammation risk
A healthcare worker fills a syringe with the Moderna COVID-19 vaccine.
Ben Hasty | MediaNews Group | beautiful pictures
For months, the authorization of Moderna’s Covid-19 vaccine for teenagers was on hold as the Food and Drug Administration considered the risk of a rare but serious form of heart inflammation affecting most are young men vaccinated for the company or Pfizer.
Moderna applied for emergency approval of a Covid vaccine for 12- to 17-year-olds in June, but the FDA told the company in October that its review of a children’s vaccine would not be completed. before January.
The agency said it needed more time to test the risk of myocarditis in the mRNA technology-based vaccine, used in both of the company’s shots. The FDA, in a statement to CNBC on Wednesday, said it is conducting the review as quickly as possible, but cannot predict how long the review will take. The review is aimed at ensuring the benefits of the vaccine outweigh the risks in adolescents, the agency said.
Messenger RNA, or vaccine mRNA, uses genetic code to teach cells how to make a protein that triggers an immune response if someone is infected with a virus. Traditional vaccines, such as Johnson and Johnson’sbringing inactivated germs into our body.
The FDA granted full approval of Moderna’s two-dose adult vaccine on Monday, and the Centers for Disease Control and Prevention is expected to release final results soon. A committee of vaccine experts will meet on Friday to review the latest data on myocarditis in adolescents and adults.
October
Moderna said in October it will wait for the FDA to approve the vaccine for children ages 6 to 11 until the teen shot gets the green light. The company is expected to release data on vaccines for children 2 to 5 years old in March.
According to the National, Heart Lung and Blood Institute, myocarditis is inflammation of the heart muscle that can lead to serious health problems. Viral infection is the most common cause of myocarditis. People are more likely to get myocarditis than with the vaccine, and the risk to the heart can be more severe, according to the Department of Health and Human Services, according to the Department of Health and Human Services.
According to a recent article in Nature Reviews Cardiology, the risk of contracting Covid-19 myocarditis is 100 times higher than developing the condition after vaccination. Depending on the study, the risk of dying from Covid-related myocarditis is between 20% and 70%, while the risk of dying from myocarditis from vaccination is less than 1%, according to the article.
Dr. Jose Romero, former chair of the CDC’s independent committee of vaccine experts, said vaccination-associated myocarditis is generally mild and resolves quickly.
Myocarditis due to Covid
“Whereas with Covid myocarditis, the disease is more severe, lasts longer, and the mortality rate can be substantial,” said Romero, who serves as health secretary in Arkansas.
Children are more likely to develop multisystem inflammatory syndrome, known as MIS-C, after contracting Covid than with vaccine-induced myocarditis. More than 6,000 children have developed MIS-C since the pandemic began. MIS-C often affects the heart, and it can lead to myocarditis and other heart complications. According to the CDC, at least 55 children have died from MIS-C.
Dr. Matthew Oster, a pediatric cardiologist at Children’s Healthcare of Atlanta, says MIS-C is much more common and children get sick much more seriously than myocarditis after vaccination. Atlanta children had 13 hospitalized children with myocarditis after the vaccine compared with more than 400 children who received MIS-C, Oster said.
“We have more than half of those require an ICU stay,” said Oster, director of the Children’s Cardiovascular Outcomes Research Program. “We have more than half of them in the ICU. That’s much more common and much more serious than vaccination-associated myocarditis.”
French and Nordic Studies
Moderna’s vaccine for adolescents came under closer scrutiny in the fall. Both French and Nordic studies showed an increased incidence of myocarditis after the second dose of Moderna vaccine in young men and young adults than after Pfizer injection. according to the European Medicines Agency. However, the European Union’s top medicine body says the benefits of both vaccines outweigh the risks because myocarditis as a side effect is rare. Sweden and other Nordic countries are restricted the use of Moderna’s photographs for young people in October. Canada also found to be at higher risk.
Moderna said in October that the company had not observed an increase in the risk of myocarditis in people under the age of 18. However, the company said it is conducting its own external data review and is committed to working closely with the FDA to support its review. Romero said the FDA made the right call to wait and get as much data as possible before making any decisions.
When Moderna asked the FDA Eligible age reduction To vaccinate adolescents 12 to 17 years of age in early June, CDCn began receiving reports of myocarditis in young men who received the Pfizer vaccine. The CDC just recommended Pfizer injections for students ages 12 to 15 in May. Pfizer and Moderna images both use mRNA technology.
Binds to vaccine mRNA
The CDC’s independent committee of vaccine experts met in June, found a link between myocarditis and mRNA vaccines However, they concluded that the benefits of vaccination outweighed the rare risks and reiterated their recommendation that children 12 to 15 years of age get the Pfizer vaccine.
Romero, who chaired the committee at the time, said it was clear that the Pfizer vaccine prevented a significant number of infections, hospitalizations and intensive care admissions, while the risk of myocarditis was similar. relatively low.
According to the CDC, myocarditis usually occurs within a week of the second dose of the mRNA vaccine. Patient-reported symptoms include chest pain, shortness of breath, and a feeling of heart palpitations.
A recent study, published in the Journal of the American Medical Association, found that 96% of the more than 800 cases of people under the age of 30 who developed myocarditis after vaccination required hospitalization, but the majority of They recovered and were discharged from the hospital. The data are based on 1,626 cases of myocarditis reported to the CDC and FDA databases between December 2020 and August.
Short hospital stay
Oster, one of the study’s authors, said hospital stays are short and children often recover from pain medication alone.
“We recommend that people with this condition limit vigorous physical activity for a period of several months, just to make sure the heart fully recovers, but what we’ve seen is that people are getting better and for the most part. So far, says Oster, the long-term results look good.
Young men aged 16 to 17 years reported the highest rates of myocarditis following the second dose of Pfizer vaccine, about 106 cases per million injections, while boys aged 12 to 15 reported 71 cases. more than a million injections, according to the study. Traditional myocarditis is also higher in teenage boys, Oster said.
Researchers are still learning what causes myocarditis after vaccination, with many scientists theorizing that testosterone may play a role. Although Pfizer and Moderna are both two-dose vaccines, Pfizer’s 30 microgram dose for people over 12 years of age is lower than the 100 microgram dose Moderna uses in adolescents. However, Romero cautions against drawing conclusions based on the doses of the two mRNA vaccines because of their differences. For example, they use different fat bubbles to deliver mRNA material to cells, which then start producing proteins that induce an immune response to protect against viruses.
Sean O’Leary, vice chair of the infectious disease committee at the American Academy of Pediatrics, said parents should know that decisions they make every day, such as driving, have their child has a higher risk of developing myocarditis after vaccination. And the risk of getting sick from Covid is much higher than the risk of getting it from the vaccine, he said.
