‘Good Decision’: Experts React to FDA Pushing Back Decision on Moderna Vaccine for Kids

By Zachary Stieber
Zachary Stieber
Zachary Stieber
Reporter
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.
November 2, 2021 Updated: November 2, 2021

The choice to delay deciding whether or not to authorize Moderna’s COVID-19 vaccine for children has merit because of concerns about post-vaccination heart inflammation, experts said.

U.S. drug regulators recently opted not to decide right now on authorization for Moderna’s shot for kids between 12 and 17, according to Moderna, which is also delaying plans to file for authorization for its jab for kids as young as 6. The company said the Food and Drug Administration (FDA) is investigating post-vaccination myocarditis among youth.

“I think that is a good decision,” Dr. Monica Gandhi, professor of medicine and associate division chief of the Division of HIV, Infectious Diseases, and Global Medicine at the University of California, San Francisco/San Francisco General Hospital, told The Epoch Times in an email.

Moderna was proposing a 100-microgram dose in kids 12 to 17 in the United States. Pfizer’s shot for that group is 30 micrograms. Moderna was planning to offer a 50-microgram dose for kids 6 to 11. Pfizer’s shot for that group is 10 micrograms.

Both vaccines are built on messenger RNA technology and have been linked to post-vaccination heart inflammation, but the occurrence of that side effect has been higher in some countries among youth after Moderna’s jab than Pfizer’s.

Finnish authorities recommended last month that Moderna’s shot not be administered to men under 30 years of age. Sweden and Norway made similar recommendations.

Preliminary data from a register-based analysis completed by Nordic countries showed that the incidence of two types of heart inflammation, myocarditis and pericarditis, was higher than expected following COVID-19 vaccination, Dr. Hanna Nohynek, chief physician of the Finnish Institute for Health and Welfare’s Unit Infectious Diseases Control and Vaccines, told The Epoch Times.

The use of Pfizer’s shot is still recommended in young men and the final results of the analysis are expected soon.

The FDA’s decision makes sense in light of the safety signal, Nohynek said. “They most likely just want to see the data more carefully and weigh the pros and cons. I think that’s what the regulatory authorities should be doing,” she added.

The FDA said previously that benefits from Moderna’s vaccine outweigh risks in deciding not to recommend some males not get the jab.

Moderna said in a statement Sunday that its own global safety database has not indicated an increased risk of myocarditis in children 17 and younger following vaccination.

But Gandhi believes the 100-microgram dosage level is likely too high for youth, noting the suspension of Moderna’s jab in the northern European countries.

“The risk of myocarditis seems to be associated with dose in young people and also too short of spacing between doses,” she said.

Some research has indicated (pdf) that extending the duration between doses—currently three weeks for Pfizer’s shot and 28 days for Moderna’s—is both safer and more effective at provoking an immune response.

Gandhi plans to vaccinate her 11-year-old with Pfizer’s shot, pending Centers for Disease Control and Prevention guidance, but will be delaying the second dose for five weeks.

Zachary Stieber
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.