In an announcement released on Wednesday, the body shared that “ongoing analyses from the FDA and the Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis and pericarditis following vaccination with the Moderna COVID-19 vaccine.”
As per the statement, this risk has been seen particularly following the second dose, with symptoms appearing a few days after receiving the jab.
“The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males,” the notice read.
The comments in the FDA press release echo similar concerns from Nordic nations that led to Spikevax, the marketing name for Moderna’s Covid vaccine, to be suspended in some form.
Icelandic health authorities announced on October 8 that it will no longer administer Moderna’s mRNA shot due to the risk of rare heart inflammation seen in other Nordic countries.
The director of Finland’s National Institution for Health and Welfare, Mika Salminen, said that “A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis.”
The findings prompted Helsinki to announce that men born in 1991 and after would no longer be given the jab.
Sweden, just one day prior, froze the use of Spikevax on all of its population under 30, citing an “increased incidence” of heart inflammation diseases, myocarditis and pericarditis. Meanwhile, Norway recommends that men under the age of 30 opt for Pfizer’s jab instead.
Concerns over heart inflammation after receiving mRNA jabs from both Pfizer and Moderna, however, are not new. In June, the Advisory Committee on Immunization Practices (ACIP) to the CDC revealed a total of 323 preliminary incidents, of what met the CDC definition of myocarditis or pericarditis, were recorded in Americans under the age of 29. A total of 309 of those were hospitalized.