The Food and Drug Administration is delaying its approval of Moderna Inc.’s COVID-19 vaccine for adolescents to study whether the vaccine could increase the risk of rare inflammatory heart disease, the Wall Street Journal reported.
The delay follows measures taken by Sweden and three other Nordic countries to limit or suspend the use of Moderna jabs for people under 30, amid concerns about the risks of myocarditis for younger men.
Researchers have found a link between rare cases of heart disease in children and the Moderna and Pfizer vaccines, both of which use a relatively new technology called mRNA.
The Journal said the FDA was reviewing data on myocarditis risk in younger men and comparing the results of those who took Moderna’s vaccine and those who received an injection of Pfizer. So far, regulators have not determined whether either vaccine increases risk.
The delay could be several weeks, but the timing is unclear, according to the report. Until the review was over, Moderna pushed the boundaries of young people. The Pfizer vaccine is approved for emergency use for children ages 12 to 15, and the New Jersey company has submitted test data seeking approval for children ages 5 to 11.
“I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it seems to be balanced between the different products,” Moderna chief medical officer Paul Burton told the WSJ in an interview.
FDA data on vaccinations among 18 to 25 year olds, who are cleared to receive Moderna’s vaccine, shows no significant difference in the rate of myocarditis in people who have taken Moderna or Pfizer vaccines, Burton said. .
The Moderna vaccine, which tens of millions of adults have received, was found to be safe in a study testing it in 3,700 adolescents, none of whom developed myocarditis, the company told the journal. The company submitted the results to the FDA for approval for use in ages 12 to 17 in June.
The agency was on the verge of giving the green light in recent weeks, the WSJ reported, but withdrew after Denmark, Finland, Norway and Sweden recommended not to use it in people. under 30 years old.