U.S. FDA Reviews Heart Health Risks from mRNA Vaccine

Massachusetts based Moderna, Inc. provided an update on October 31, 2021, that the U.S. Food and Drug Administration (FDA) had notified the Company that it would require additional time to complete its assessment of Moderna’s recent Emergency Use Authorization (EUA) request.

The new EUA request is for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.

Moderna stated in a press release, ‘it does not yet have access to data from some recent international analyses.’

Late on October 29, 2021, the FDA informed Moderna that the agency requires additional time to evaluate recent international analyses of the risk of myocarditis after vaccination. 

The FDA notified Moderna that this ‘heart health risk’ review may not be completed before January 2022. 

An increased risk of myocarditis has been described for mRNA COVID-19 vaccines, including the Moderna COVID-19 vaccine, known as SpikeVax, particularly in young men and following the second dose. 

The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have stated that myocarditis following vaccination with mRNA vaccines has been rare and generally mild.

On October 16, 2021, the Wall Street Journal was the first to report the FDA was reviewing SpikeVax's risk of generating inflammatory heart conditions.

However, the CDC and the U.S. FDA staff began reporting heart health risks to their vaccine advisory committees in June 2021.

Tom Shimabukuro, M.D., MPH, MBA, with the CDC's Vaccine Safety Team, presented COVID-19 Vaccine Safety Updates following mRNA vaccination on June 10, 2021.

It is estimated that over 1.5 million adolescents have received Moderna’s SpikeVax COVID-19 vaccine. 

To date, the observed rate of myocarditis reports in those less than 18 years of age in Moderna’s global safety database does not suggest an increased risk of myocarditis in this population. 

In reaction to this FDA news, Moderna stated it ‘will delay filing a request for EUA of mRNA-1273 at the 50 µg dose level in the pediatric population (6-11 years of age) while the FDA completes its review.’

‘Moderna is committed to conducting its careful review of new external analyses as they become available.’

Moreover, the Company confirmed ‘it is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence.’

The FDA initially issued a EUA enabling the COVID-19 Vaccine Moderna (SpikeVax) to be distributed in the U.S. for individuals 18 years of age and older on December 18, 2020. 

Then on August 12, 2021, the FDA amended SpikeVax's EUA to allow for an additional third dose in specific immunocompromised individuals.

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