Sweden and Denmark are discontinuing the use of the Modern COVID vaccine for younger age groups
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 cardiovascular 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 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.
Shares in Moderna fell 4.9 percent, or $ 16.08 (€ 13.91), to $ 316.11 (€ 273.44) in afternoon trading on Wednesday.
A spokesman for Moderna said in an email that the company was aware of the decisions taken by regulators in Denmark and Sweden to pause the use of the vaccine in younger people due to the rare risk of myocarditis and or pericarditis.
“These are usually mild cases and individuals tend to recover within a short time after standard treatment and rest. The risk of myocarditis increases significantly for those affected by COVID-19, and vaccination is the best way to protect against this.”
‘6 times more like to develop myocarditis’
According to a US study that has not yet undergone peer review, young men under the age of 20 are up to six times more likely to develop myocarditis after receiving COVID-19 than those who have been vaccinated.
Denmark said that although the Pfizer / BioNTech vaccine was used as the main alternative for people aged 12-17, it had been decided to pause giving the Moderna vaccine to people under the age of 18 according to a “precautionary principle”.
“In the preliminary data … there is a suspicion of increased risk of heart inflammation when vaccinated with Moderna”, says the Danish health authority 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It referred to data from a as yet unpublished Nordic study, which would now be sent to the European Medicines Agency (EMA) for further assessment.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.
Inflammation is an “extremely rare” side effect
Sweden and Denmark said that they now recommended the Comirnaty vaccine from Pfizer / BioNTech instead.
The Danish health authority said 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.
Although both vaccines are based on mRNA technology, the Pfizer shot contains 30 micrograms of vaccine per dose compared to 100 micrograms in the Modern vaccine.
Modern COVID vaccine “may have a higher risk”
Data from one of two US vaccine safety databases have also suggested that the Mother’s vaccine may carry a higher risk of myocarditis among young people.
The vaccine is not approved for people under the age of 18 in the United States.
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, says Geir Bukholm, head of infection control at the Norwegian Institute of Public Health.
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.