Sweden and Denmark said on Wednesday that they are pausing the use of the Mother’s COVID-19 vaccine for younger age groups following reports of possible rare side effects.
The Swedish Health Care Agency said it would pause using the image for people born in 1991 and later, as data point to an increase in myocarditis and pericarditis among adolescents and young adults who have been vaccinated. These conditions involve an inflammation of the heart or its lining.
“The link is particularly clear with regard to Maternal vaccine Spikevax, especially after the second dose,” said the health agency, adding that the risk of being affected was very small.
Denmark said that while using the Pfizer / BioNTech vaccine as the main alternative for people aged 12-17, it had decided to pause giving the Moderna vaccine to people under 18 according to a “precautionary principle”.
“In the preliminary data … there is a suspicion of increased risk of heart inflammation when vaccinated with Moderna,” the Danish health authority said in a statement.
It referred to data from a as yet unpublished Nordic study, which would now be sent to the European Medicines Agency (EMA) for further assessment. Final data was expected within a month, it added.
Sweden and Denmark said that they now recommended the Comirnaty vaccine, from Pfizer / BioNTech, instead.
The Danish health authority said that it had made the decision even though “heart inflammation is an extremely rare side effect that often has a mild course and disappears on its own”.
In July, the EMA’s safety committee concluded that inflammatory heart disease can occur in very rare cases after vaccination with Comirnaty or Spikevax, more often in younger men after the second dose.
The benefits of shots based on so-called mRNA technology used by both Moderna and Pfizer-BioNTech to prevent COVID-19 continue to outweigh the risks, say regulators in the US, the EU and the World Health Organization.
Data suggest that reported cases of rare heart inflammation are relatively higher after Moderna’s vaccine compared to Pfizer / BioNTech shots, Canadian health officials said last week.
Norway already recommends the Cominarty vaccine to minors and said on Wednesday that it repeats this.
“Men under the age of 30 should also consider choosing Cominarty when they are vaccinated,” said Geir Bukholm, head of infection control at the Norwegian Institute of Public Health, in a statement.
A Finnish health official said Finland expected to announce a decision on Thursday.
EMA approved the use of Comirnaty in May, while Spikevax received a nod for children over 12 in July.