The FDA is investigating a condition called myocarditis
The Food and Drug Administration is delaying a Decision on authorization Modern Inc. NS mRNA -1.69% COVID-19 Vaccine for Adolescents To assess whether the shot might increase the risk of the rare inflammatory heart condition, according to people familiar with the matter.
After the strengthening of the four Nordic countries Stance Against Giving Moderna Vaccines to Young Adults Last week, the FDA took another look at the risk of this condition, known as myocarditis, in young men who took Moderna’s vaccine, especially compared to those who received the vaccine. pfizer Inc. and BioNTech SE, people said.
So far, regulators have not determined whether the risk has increased, the people said. The delay could be several weeks, but the timing is not clear, said one of the people.
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People said the agency plans to review the data before deciding whether to extend vaccine eligibility to younger people.
Myocarditis risk is the latest complication for vaccine manufacturers, regulators and public-health officials, who are encouraging vaccination to protect against COVID-19. a rare blood clotting condition hurt the rollout of astraZeneca PLC and johnson and johnson shot.
The risk of myocarditis has also been an issue in many people exposed to vaccination but there are concerns about side effects.
Parents Eager to vaccinate your teen Still have access to the Pfizer-BioNTech vaccine. The delay in authorization may add to the hesitation of some who have stayed because of security concerns. However, the FDA’s caution may also put some hesitant parents at ease.
Depending on what the FDA decides, Pfizer’s vaccine could be made Favorite Shots for Teens and Kids As the US expands its vaccine rollout, further solidifying its leading position in the US and global market.
Moderna’s chief medical officer Paul Burton said the FDA’s own data on vaccinations among 18- to 25-year-olds showed no significant difference in rates of myocarditis among those who had either Moderna or Pfizer-BioEntech vaccines.
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“I think people can be reassured that the risk of myocarditis with the mRNA vaccine is low, it seems to be balanced between the different products,” he said in an interview.
Dr. Burton said Moderna has asked Nordic countries for their data, but has not yet seen it.
Chief executive Stefan Bansel said during an interview this week that the benefits of the company’s vaccine, including its strong and long-lasting protection, outweigh the risks.
“Some countries want to be ultra-Orthodox, it’s certainly their prerogative, but from the data I’ve seen, I would feel comfortable with anyone in my family who is a young male getting vaccinated,” he said. .
A Centers for Disease Control and Prevention study published last month Indicates that Moderna’s vaccine is more effective at keeping people away from hospital Compared to Pfizer or Johnson & Johnson.
The Moderna shot, taken by millions of adults, was found to be safe in a study that tested it in 3,700 adolescents. The company said no cases of myocarditis were reported in the trial.
Based on the findings, Moderna asked the FDA in June to expand use to children ages 12 to 17. The agency was close to issuing the green light in recent weeks, the people said, but withdrew last week after Denmark, Finland, Norway and Sweden recommended against use in people under the age of 30.
Moderna’s vaccine is currently authorized for use in the United States for people 18 years of age and older. FDA allows use of Pfizer-BioNtech vaccine in children under 12 years of age In May, about a month later The companies had filed their request in April.
According to the US Census Bureau, there are about 25 million children in the US between the ages of 12 and 17. According to the Centers for Disease Control and Prevention, more than 12 million American teens have already been fully vaccinated with the Pfizer-BioNTech vaccine.
Myocarditis refers to a condition marked by inflammation of the lining around the heart. It is usually caused by a viral infection. In extreme cases, it can lead to abnormal heartbeat, heart failure, and death.
The condition has been reported in a small number of people receiving Pfizer-BioNtech and Moderna Vaccines, which use the same messenger RNA technology. Health experts advising the Centers for Disease Control and Prevention have said there appears to be a link.
The labels of both shots carry a warning about an increased risk of myocarditis after vaccination. According to the researchers, cases among those receiving the vaccine are usually mild.
Health officials encourage vaccination, noting that cases of myocarditis are rare and tend to be mild. They say that the benefits of vaccination outweigh the risks. Health experts say that myocarditis is also a side effect of COVID-19 and some studies indicate that it occurs more after COVID-19 infection than vaccination.
An Israeli study of the health records of nearly two million people aged 16 or older, published last month in the New England Journal of Medicine, found that COVID-19 more likely to cause myocarditis Compared to the Pfizer-BioNTech vaccine. Israel is almost exclusively using the Pfizer-BioNTech vaccine.
Preliminary information from multiple US health-claims data sources, which an FDA official presented Thursday to a panel of vaccine experts advising the agency, showed the incidence rates of myocarditis and another heart-related condition called pericarditis. Turns, indicated, were highest among men between the ages of 18 and 18. 25 years after the second dose of mRNA vaccine.
The FDA analysis did not find a significant difference in the incidence rate of myocarditis between Moderna and Pfizer-BioNTech vaccines.
The Nordic countries cite unpublished data in an ongoing study, however, showing that the relative incidence of myocarditis is higher in people who have received Moderna’s vaccine compared to Pfizer-BioEntech.
Nordic health officials said they expect the data contained in their guidance on the Moderna vaccine to be made public by the end of the year.
Sarah Wiksmon Watley, a pediatrician and senior medical officer, said the data indicated cases of myocarditis are more common after the second dose of Moderna Vaccine than Pfizer’s vaccine, especially in younger men, although overall myocarditis in Norway cases are few. With the Norwegian Institute of Public Health’s Department of Communicable Diseases and Vaccines.
Norway is still analyzing the data, she said, to assess whether the risk of myocarditis warrants a permanent recommendation.
14 report by the Wall Street Journal, the European Medicines Agency’s safety database reported three times as many reports of myocarditis among Moderna vaccine recipients as among Pfizer-BioNTech recipients.
The database includes unconfirmed reports of side effects that are directly related to vaccines being investigated.
Both Moderna and Pfizer-BioNTech vaccines have been approved by drug regulators in the European Union and the UK for use in people 12 years of age and older; in practice, some European countries limit the use of Moderna in adolescents , and the UK has offered a single dose. Pfizer Vaccine for Young Adolescents.