Moderna's mRNA COVID-19 Vaccine Under Side Effect Review by U.S. FDA

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 reported action follows recent Scandinavian country changes to limit or suspend using SpikeVax for certain men under the age of thirty. These countries have reported Myocarditis and/or Pericarditis cases in men,

In early July 2021, the European Medicines Agency vaccine safety committee concluded that Myocarditis/Pericarditis could occur in very rare cases following vaccination with the mRNA COVID-19 vaccines.

These heart condition symptoms can vary but often include breathlessness, irregular heartbeat, and chest pain. says the FDA.

However, this heart inflammation concern was not highlighted during the FDA's Vaccines and Related Biological Products Advisory Committee meeting on October 14, 2021.

Since September 8, 2021, the U.S. CDC confirmed it was actively monitoring heart inflammation cases after COVID-19 vaccination. 

The SpikeVax COVID-19 Vaccine Moderna (mRNA-1273) is an Authorized Messenger RNA (mRNA) vaccine against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike protein.

Moderna, Inc. designs its mRNA vaccines using the virus's sequence, not on the virus itself. 

As of October 16, 2021, over 153 million SpikeVax vaccines have been administered in the U.S.

The CDC says if you had a severe or immediate allergic reaction after getting the first dose of an mRNA COVID-19 vaccine, you should not get a second dose of either of the mRNA COVID-19 vaccines.

And if you would like to report an adverse event, side effect, or reaction from a COVID-19 vaccine, please use the following link: https://vaers.hhs.gov.