Sweden Public Health Agency extended a moratorium indefinitely on the use of the Moderna mRNA-1293 vaccine to anyone age 30 and under. While this extension was to end on December 1, the Swedish government is all but banning the use of the vaccine on younger people due to heightened risk of heart inflammation. Thus, moving forward in the most populated of the Scandinavian countries, the laws of the land deny anyone born after 1990 from receiving this vaccine, and instead, these people are offered the Pfizer vaccine in a move that can only be considered good for Pfizer’s market share. The rest of the Nordic nations have also imposed restrictions on using the shots on young people. Heart inflammation in younger people is a known adverse effect associated with Moderna—young males face higher risks.

TrialSite reported on October 6 Sweden halted the use of the mRNA COVID-19 vaccine on people under the age of 30 due to safety concerns. Just a couple of days later TrialSite shared with global audiences that Iceland made the same move, along with the rest of the Scandinavian countries, to either halt or in the case of Norway, discourage the use of the Moderna vaccine in younger people due to the safety risks.

What about the U.S. FDA?

The U.S. Food and Drug Administration (FDA) authorized the use of Moderna mRNA-1273 to prevent COVID-19 in individuals 18 years of age and older on December 18, 2020. By August 25, 2021, Moderna completed its submission for biologics license application (BLA) with the FDA. On September 16th Canada approved the vaccine. By October 20 the FDA authorized a booster dose of mRNA-1273 under the emergency use authorization category.

Mounting concern of heart inflammation risk, particularly in young males apparently caused the FDA to delay their decision regarding adolescent access to the mRNA-1273 vaccine. According to a Reuters account, the regulatory body acted to investigate the data for risks associated with the rare heart condition. Undoubtedly, the Nordic actions over the past months caught the attention of the American regulators.

According to a recent headline in UK’s Daily Mail, the Public Health Agency of Sweden pointed to unpublished data signals evidencing the risk although they acknowledged ‘The risk of being affected is very small.’ Nonetheless, state health authorities don’t declare such precautions unless they have serious concerns. Pfizer will undoubtedly seize the opportunity.

Call to Action: If you have an adolescent ensure you understand the risks associated with the COVID-19 vaccines.