The Food and Drug Administration is delaying its approval of Moderna Inc.’s COVID-19 vaccine for teens to study whether the shot could increase the risk of a rare inflammatory heart condition, The Wall Street Journal reported.
The delay follows moves by Sweden and three other Nordic countries to limit or suspend using the Moderna jabs for people under 30, over concerns about the risks of myocarditis for younger men.
Researchers have found a link between rare cases of the heart condition in children and the Moderna and Pfizer vaccines, both of which use a relatively new technology called mRNA.
The Journal said the FDA is taking another look at data on the risk of myocarditis among younger men, and is comparing the results for those who took Moderna’s vaccine, and those who got a Pfizer shot. So far, the regulators haven’t determined if either of the vaccines elevates the risk.
The delay could be several weeks, but the timing is unclear, the report said. Until the review is complete, the Moderna shot off limits for young people. The Pfizer vaccine is approved for emergency use for kids aged 12 to 15, and the New Jersey company has submitted trial data seeking approval for kids aged 5 to 11.
“I think people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products,” Moderna Chief Medical Officer Paul Burton told WSJ in an interview.
FDA data on vaccinations among 18- to 25-year-olds, who are cleared to get Moderna’s shot, doesn’t show any significant difference in the rate of myocarditis among people who took the Moderna or the Pfizer vaccines, Burton said.
The Moderna shot, which tens of millions of adults have received, was found safe in a study testing it in 3,700 adolescents, none of whom developed myocarditis, the company told the paper. The company submitted the findings to the FDA seeking approval for its use for 12- to 17-year-olds in June.
The agency was close to issuing a green light in recent weeks, WSJ reported, but pulled back after Denmark, Finland, Norway and Sweden recommended against use in people under 30 years old.