The U.S. Food and Drug Administration (FDA) on Friday was forced to own up to an issue with Moderna’s COVID-19 vaccine, Fox News reports, admitting that the vaccine can cause heart inflammation issues.
The FDA apparently felt compelled to make the announcement given the fact that Moderna’s COVID-19 vaccine has now been restricted in several other countries.
For months, it was known that heart inflammation is a potential side-effect of taking the Moderna COVID-19 vaccine. Reports have indicated that the side-effect is more likely to occur in males under the age of 30.
Because of that potential complication, several Nordic countries have begun to restrict the use of Moderna’s COVID-19 vaccine, as CNBC reported. Sweden, for example, has suspended the use of the Moderna vaccine for all people under the age of 30, and Denmark has paused the Moderna vaccine for all people under 18.
Finland, on the other hand, is now advising the at-risk group — males under the age of 30 — to not receive the Moderna vaccine. In addition, Norway is recommending that people go with the Pfizer vaccine as an alternative.
All of those countries based their decisions on an unpublished study that is set to be reviewed by the European Medicines Agency’s (EMA) adverse reaction committee. According to Swedish research, the study found a “very small” but “increased” risk of “side effects such as inflammation of the heart muscle.”
The FDA, in light of the alarming restrictions enacted by the aforementioned Nordic countries, made the decision to issue a response on Friday.
The FDA responds
In the response, the FDA acknowledged the fact that the Moderna vaccine does carry an increased risk of heart inflammation among males under the age of 30. “The FDA is aware of these data,” an official said.
The FDA official, however, went on to say that “at this time, FDA continues to find that the known and potential benefits of vaccination outweigh the known and potential risks for the Moderna COVID-19 Vaccine.”
Moderna also released a similar statement, saying that it is “aware of the very rare occurrence of myocarditis and/or pericarditis following administration of mRNA vaccines against COVID-19.”
It added: “These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest. The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this.”
The FDA has yet to give full approval to Moderna’s vaccine, whereas it has given such approval to Pfizer’s version. One wonders whether this side effect could be part of the reason why that approval is lagging behind.