Federal health officials are conducting an investigation into the effects of the Moderna COVID-19 vaccine following new research that showed it may be linked to a higher risk of heart inflammation in young adults than previously though, according to a report from The Washington Post.
Two people familiar with the review told the Post that the heart condition, called myocarditis, is likely still extremely rare, but added that the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are looking into new Canadian data suggesting a greater risk among a specific demographic that have received the Moderna vaccine.
The sources, who spoke on the condition of anonymity, said that the research shows a potentially greater risk of heart inflammation among Moderna than Pfizer-BioNTech recipients, most notably for men under the age of 30.
The FDA in June added a warning label to the two mRNA vaccines about the potential increased risk of myocarditis, though the CDC, Department of Health and Human Services and 15 of the leading national medical and public health organizations said in a joint statement that the risk of heart inflammation was much greater among people infected with COVID-19.
“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” the groups said in a statement at the time. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment.”
In response to the Post report, FDA spokeswoman Stephanie Caccomo said the agency would not discuss internal meetings and deliberations, but added that it is “absolutely committed to reviewing data as it becomes available to us.”
“We have previously communicated about myocarditis and COVID-19 vaccines and if new information changes the risk/benefit profile, we will update the public accordingly,” Caccomo said.
The CDC said that its Advisory Committee on Immunization Practices “has and continues to review reports of myocarditis and pericarditis following COVID-19 mRNA vaccination.”
“CDC, FDA, and our vaccine safety partners are actively monitoring these reports, including reviewing data and medical records, to learn more and understand any relationship to COVID-19 mRNA vaccination,” the CDC added, according to the Post.
The Hill has reached out to Moderna for comment.
Last month, a European Medicines Agency committee echoed that heart inflammation was “very rare” among mRNA COVD-19 recipients.