The FDA is pausing approval of Moderna’s Covid-19 vaccine until it investigates cases of myocarditis, the Wall Street Journal reports.
According to an anonymous source, the federal regulatory agency is investigating whether the mRNA jab could lead to higher incidences of the supposedly rare side effect, described as an “inflammation of the heart muscle” by the Mayo Clinic, after several Nordic countries recommended against Moderna’s use in young children.
From the WSJ:
The Food and Drug Administration is delaying a decision on authorizing Moderna Inc.’s MRNA -2.31% Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.
After four Nordic countries strengthened their stances against giving Moderna vaccines to younger adults last week, the FDA has been taking another look at the risk of the condition, known as myocarditis, among younger men who took Moderna’s vaccine, especially compared with those who received the vaccine from Pfizer Inc. PFE -0.43% and BioNTech SE, BNTX -1.06% the people said.
So far, the regulators haven’t determined whether there is an elevated risk, the people said. The delay could be several weeks, but the timing is unclear, one of the people said.
Myocarditis cases are reportedly contributing to vaccine-hesitant skepticism over the vaccine.
The Journal notes regulators are being extra cautious after several European countries halted the AstraZeneca vaccine rollout over heart complication issues, with Johnson & Johnson’s Covid vaccine showing similar issues in the US.