mRNA COVID-19 Vaccine Heart Inflammation Risk Confirmed

The U.S. Food and Drug Administration (FDA) issued a press statement on October 20, 2021, which included confirmation of 'ongoing analyses from the FDA and the US Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions related to the Moderna (SpikeVax) COVID-19 vaccine.'

Both myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported following vaccination with SpikeVax, particularly following the second dose.

Typically, the onset of heart inflammatory symptoms has been a few days following SpikeVax vaccination, says the FDA.

Furthermore, the FDA confirmed the observed heart risk is higher among men under 40 years of age, particularly younger men 18 through 24.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, stated: “We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks.”

Earlier, Tom Shimabukuro, M.D., MPH, MBA, with the CDC's Vaccine Safety Team, presented the COVID-19 Vaccine Safety Update on June 23, 2021. The analysis of preliminary reports of myocarditis/pericarditis is in progress. And limited outcome data suggest most patients (at least 81%) had complete recovery of symptoms.

Then on September 8, 2021, the CDC and its partners confirmed they were 'actively monitoring reports of myocarditis and pericarditis after COVID-19 vaccination. Active monitoring includes reviewing data and medical records and evaluating the relationship to COVID-19 vaccination.'

And recently, Nordic countries released data on the increased incidence of myocarditis and pericarditis after vaccination with Moderna's vaccine in early October 2021.

These heart issues appear to be related to mRNA vaccines given as the first dose, reported Norway. And in Sweden, the use of Moderna's SpikeVax vaccine was restricted to individuals born before 1991.

Then the Wall Street Journal reported on October 16, 2021, the U.S. FDA confirmed it is reviewing Moderna's SpikeVax COVID-19 vaccine's risk of generating inflammatory heart conditions in young men.

"I think people can be reassured that the risk of myocarditis (from) an mRNA vaccine is low, it appears to be balanced between the different products," Moderna Chief Medical Officer Paul Burton told WSJ.

The FDA's updated disclosures say, 'you should seek medical attention right away if you have any of the following symptoms after receiving the Moderna COVID-19 Vaccine: Chest pain, Shortness of breath, or feelings of having a fast-beating, fluttering or pounding heart.'

And report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967.