FDA Holds off Moderna Vaccine for Teens Due to Myocarditis Concerns

Photo: (Photo : RADEK MICA/AFP via Getty Images)

Parents who prefer the Moderna vaccine for teens will need to wait for a few more weeks. The U.S. Food and Drug Administration (FDA) has delayed its approval due to concerns over myocarditis, also known as heart inflammation that causes abnormal heart rhythms.

According to The Wall Street Journal, FDA plans to probe more data and compare the results of previous clinical trials to determine the risk of myocarditis in male vaccine recipients. This is after receiving reports that Denmark, Finland, Norway, and Sweden had stopped giving Moderna jabs for those under 30 years old.  

Researchers had seen a small number of cases linking heart inflammation in both Moderna and Pfizer vaccines, as these scientific inventions use the same mRNA technology. Currently, the FDA has limited the distribution of Moderna vaccines to young people until the FDA review is complete and final.

However, Paul Burton, the chief medical officer from Moderna, told The Journal that the public could be reassured that the risk is low and balanced between the two leading vaccine brands in the U.S.

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The outcome of Moderna Clinical Trials

In August, Moderna sought an emergency use authorization (EUA) for 12 to 17 years old with the FDA after submitting the results of the clinical trials done among 3,730 teenagers. The study showed that the Moderna vaccine for teens brought on a similar immune response to adults' trials. The teenagers who participated in the trial also exhibited similar minor side effects as the adults, such as headache, fatigue, and pain in the arm.

Dr. Gary Berman, who was one of the principal investigators of the study in Minneapolis, said that the outcome among the younger group proves that the Moderna vaccine is safe and effective among the 12 to 17 years old. Berman is aware of the myocarditis cases, but he believes that this is rare among the younger recipients. For the expert, the outcome is still in line with the pronouncements of various health agencies that vaccine is better at protecting the children versus no vaccination at all. 

Dr. Wassim Ballan of the Phoenix Children's Hospital told Forbes that the Moderna vaccine trial in teens was larger than the trials conducted by Pfizer, which was among 2,260 children. However, Moderna's result had a 96 percent effective outcome while Pfizer had 100 percent. Pfizer's age group was also narrower at 12 to 15 years old compared to Moderna's trials.

However, the slight differences do not mean that one vaccine for teens is better than the other. For parents in doubt on which vaccine to get, they could speak to their children's pediatrician for guidance. However, Dr. Lowell Gordon of the Families Together medical facility in Orange County said that the better vaccine is still whatever the families can access.

Vaccine Incentives

Meanwhile, as the U.S. government continue to encourage or mandate vaccination, Minnesota Gov. Tim Walz announced that children between the ages of 12 to 17, who get their first dose beginning October 18 to November 9, are eligible to receive a $200 Visa gift card under the "Kids Deserve a Shot" initiative. 

On the other hand, teenagers who get fully vaccinated by the end of 2021 can qualify for a $100,000 scholarship for any public or private college institution within the state. To date, some 54 percent of teenagers in Minnesota have had their first jab.

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