FDA Reviewing International Data Before Approving Moderna Vaccine For Teens Due To Myocarditis Concerns
BOSTON (CBS) -- Moderna submitted an application to the FDA for emergency use authorization of its COVID-19 vaccine in kids ages 12 to 17 back in June.
And since May, more than 1.5 million teens have received the Moderna vaccine, at the same dose as adults. But some European countries have suspended the vaccine in people under 30 over concerns that the vaccine might cause myocarditis or inflammation of the heart.
The FDA is reportedly reviewing more international data before making a decision on whether to greenlight the vaccine in kids ages 12 to 17 here.
In the U.S., there have been rare reports of myocarditis associated with both the Pfizer and Moderna vaccines, typically in males ages 16 to 29, but the condition is almost always easily treated and temporary. And it's seen even less common in younger children.
While we want regulators to continue to monitor closely for vaccine-related issues, we hear a lot about concerns related to myocarditis, but I want to remind parents that the risk is incredibly small. And the risk that a child or teen will develop heart-related complications after getting infected with the coronavirus is considerably higher than any risk from the vaccines.
The FDA may not reach a decision on whether to grant authorization to the Moderna vaccine in kids ages 12 to 17 until January.