Three Nordic countries pull Moderna vaccine off the market for young people
Sweden, Denmark, and Finland announced that they are suspending the use of the Moderna vaccine for COVID-19 for individuals thirty years of age or younger, due to safety concerns.
“In the preliminary data…there is a suspicion of an increased risk of heart inflammation, when vaccinated with Moderna,” the Danish Health Authority said in a statement.
The decision was based on data from a Nordic study that has not yet been published. The data from the study showed concerning patterns of myocarditis and pericarditis in young people who have been vaccinated by Moderna.
“The connection is especially clear when it comes to Moderna’s vaccine Spikevax, especially after the second dose,” the Swedish health agency said. They also made clear that the risk of these dangerous side effects is small.
The European Medicines Agency (EMA) is now expected to review the study and provide further insight and assessment, and in the meantime, Sweden and Denmark are now recommending the Pfizer/BioNTech vaccine for young people instead.
The EMA announced this summer that inflammatory heart conditions can occur in very rare cases after vaccination with either Moderna or Pfizer/BioNTech, and that those reactions were clustered among young males following their second dose. The EMA approved the Moderna vaccines in July for people aged 12 and up.
“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,” a Moderna spokesperson said in a statement.
“Heart inflammation is an extremely rare side effect that often has a mild course and goes away on its own,” said the Danish Health Authority.
The benefits of vaccination (by either Moderna and Pfizer-BioNTech) continue to outweigh the risks, according to health authorities in the United States, the European Union, and the World Health Organization.
The vaccine is not yet approved for people under 18 in the United States.