Moderna (MRNA) - Get Moderna, Inc. Report slipped Friday after the U.S. Food and Drug Administration reportedly delayed a decision on authorizing the biotech's COVID-19 vaccine for adolescents to assess whether the injection may lead to heightened risk of a rare inflammatory heart condition.
Shares of the Cambridge, Mass. company were down 3.5% to $320.30 at last check.
The FDA has been taking another look at the risk of myocarditis, among younger men who took Moderna’s vaccine, especially compared with those who received the vaccine from Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Sponsored ADR Report, the Wall Street Journal reported, citing people familiar with the matter.
The agency made the decision after four Nordic countries strengthened their positions against giving Moderna vaccines to younger adults.
Earlier this month health officials in Sweden and Denmark halted COVID-19 shots from the company for younger people following cases of myocarditis.
U.S. regulators have not determined whether there is an elevated risk. The delay could be several weeks, but the timing is unclear.
The FDA plans to further review data before deciding on whether to extend the vaccine’s eligibility to younger people
Moderna Chief Medical Officer Paul Burton told the Journal in an interview that he thought "people can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products.”
The FDA’s own data on vaccinations among 18- to 25-year-olds, a young age group 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-BioNTech vaccines, Burton said.
The Moderna shot, which has been taken by tens of millions of adults, was found to be safe in a study testing it in 3,700 adolescents. No cases of myocarditis were reported in the trial, the company said.
On Thursday an FDA advisory panel unanimously voted to recommend Moderna COVID booster shots for emergency use in individuals aged 65+ and vulnerable populations.
The FDA did not immediately respond to a request for comment.