The health regulator is investigating the risk of myocarditis, a form of heart inflammation, in children aged 12 to 17, Moderna’s statement said. The review may not be completed before January of next year, the company said.
“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, while adding that the “safety of vaccine recipients is of paramount importance to Moderna.”
Moderna added it would delay filing a request for an emergency use authorization for a smaller dose of its mRNA vaccine among children aged 6 to 11. Late last week, the FDA granted emergency use authorization of pharmaceutical giant Pfizer’s COVID-19 vaccine for children in that age group, although the U.S. Centers for Disease Control and Prevention (CDC) has to sign off on it before it can be distributed.
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
In the United States, Moderna’s two-dose vaccine is only available to those aged 18 and older. Several Scandinavian countries, including Finland and Sweden, issued statements earlier this month against providing the Moderna shot to younger adults and children—primarily younger males—due to the risk of myocarditis.
Sweden said it would pause the vaccine for people under the age of 30, and Denmark did the same for those under 18. Finland said that males under the age of 30 shouldn’t receive the jab, while Icelandic officials added over the weekend that they would suspend use of the shot. Last week, Swedish health officials extended their pause of Moderna’s vaccine for those under the age of 30.
The FDA issued a response in mid-October after the Nordic countries had limited Moderna’s usage, again stating that the shot’s benefits outweigh the risks.
“The FDA is aware of these data. At this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine,” an FDA official said in a statement in response to the Nordic nations’ decision to suspend the vaccine for certain age groups.
Moderna’s Sunday statement noted that about 1.5 million children have been given its COVID-19 vaccine, adding that the risk of myocarditis appears to be small.
“An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose,” the Cambridge, Massachusetts-based company stated.
“Moderna is committed to conducting its own careful review of new external analyses as they become available,” Moderna said, but it stressed that “the company does not yet have access to data from some recent international analyses.”
FDA officials notified Moderna of its decision to delay the designation on Oct. 29, according to the pharmaceutical company.
The FDA has not immediately responded to a request for comment after Moderna’s statement.
The move comes as an increasing number of doctors and epidemiologist have raised concerns about COVID-19 vaccine mandates, as well as potential side effects, in children.
Dr. Tracy Høeg, an epidemiologist and public health expert, told NTD last week that she is “afraid that parents who have questions about the safety—maybe they are concerned, they have a son who might be at risk for myocarditis—will then really not have a say in whether or not the child gets a second dose.”