DENVER, Colo. — The Food and Drug Administration will need more time to decide whether to give emergency use authorization to Moderna’s covid vaccine for kids ages 12 to 17.
The FDA is investigating reports of a rare side effect that causes inflammation of the heart muscle.
“It’s called myocarditis, which is the rare side effect that we’ve seen with the Moderna vaccine specifically,” said Dr. Joshua Williams, a pediatrician at Denver Health. “Now the FDA is looking into whether or not there is an increasing concern at the rate of myocarditis in younger recipients of the vaccine.”
The FDA is reviewing recent international analyses of the side effect, according to Moderna.
In a statement, Moderna said it is estimated that over 1.5 million adolescents have received its COVID-19 vaccine. The company says the observed rate of myocarditis reports in those less than 18 does not suggest an increased risk.
According to Williams, the international study is the main difference between why the Pfizer vaccine has been approved for teens over Moderna.
“For parents who are still wanting to protect their children from coronavirus, getting the Pfizer is certainly an option,” Williams said. “We know that the risk of myocarditis from the vaccine are real and they exist, but we have to remember that over 5,000 children have suffered from multi-inflammatory syndrome. This is a very serious kind of immune system dysregulation that accompanies COVID infection and 650 kids have died. While the risk of myocarditis is real, it’s also very low and generally very mild in children limited to the first few days and uncommon after the second vaccine.”
Infectious disease expert and researcher Dr. Thomas Moore says the delay of the Moderna vaccine for teens can actually help combat vaccine hesitancy.
“To be honest, the risk of having inflammation of the heart or any other side effect from the vaccine are exceptionally rare of the risk of death and long-term side effects of the disease itself,” Moore said. “Nevertheless, convincing people that is the case is going to require some effort and that’s where the FDA is going to take their time. The main thing is to be as transparent and reassuring as possible.”
According to a statement released by Moderna, the FDA notified the company that this review for kids ages 12 to 17 may not be completed before January 2022.