The Food and Drug Administration said Sunday that it will need more time to decide if the Moderna COVID-19 vaccine for children ages 12-17 warrants approval.
The FDA said it wants to investigate claims of a rare side effect — inflammation of the heart muscle, or myocarditis — in those who received the shot so far.
- “The safety of vaccine recipients is of paramount importance to Moderna. The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” Moderna said in a statement.
United States federal health officials said in August that they would be looking into the Moderna COVID-19 vaccine to see if it leads to more uncommon side effects, like the heart condition myocarditis, as I wrote for the Deseret News.
Finland, Sweden and Denmark announced in early October that they would stop issuing the Moderna mRNA COVID-19 vaccine due to reports of the rare cardiovascular side effect, a rare inflammation of the heart muscle.
There have been questions for months about whether or not the coronavirus vaccine can cause inflammation of the heart muscle. Reports often suggested myocarditis could be a side effect of the COVID-19 vaccine, as the Deseret News reported. Claims have pointed to both the Pfizer and Moderna vaccines.