F inland will pause the use of Moderna’s Covid-19 vaccine for men born in 1991 and later due to reports of a rare cardiovascular side effect, the institute for health and welfare said on Thursday (Oct 7).
Swedish and Danish health officials had announced on Wednesday afternoon they would pause the use of the Moderna vaccine for all young adults and children.
“A Nordic study involving Finland, Sweden, Norway and Denmark found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis,” director Mika Salminen from the health institute said.
Professor Salminen said myocarditis, which means heart muscle inflammation, usually heals on its own in a few days. He said as a precaution Finland would only give Pfizer’s vaccine to boys and young men.
The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults who had been vaccinated.
“The connection is especially clear when it comes to Moderna’s vaccine Spikevax, especially after the second dose,” the health agency said, adding that the risk of being affected was very small.
Myocarditis is inflammation of the heart muscle while pericarditis is inflammation of the lining outside the heart.
A Moderna spokesman said in an e-mail that the company was aware of the decisions by regulators in Denmark and Sweden to pause the use of its vaccine in younger individuals because of the rare risk of myocarditis and or pericarditis.
“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.”
According to one United States study that has yet to undergo peer review, young males aged under 20 are up to six times more likely to develop myocarditis after contracting Covid-19 than those who have been vaccinated.
Denmark said that while it used the Pfizer-BioNTech vaccine as its main option for people aged 12 to 17, it had decided to pause giving the Moderna vaccine to people below 18 years old according to a “precautionary principle”.
“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 EMA’s safety committee concluded in July that inflammatory heart conditions can occur in very rare cases following vaccination with Comirnaty or Spikevax, more often in younger men after the second dose.
The benefits of shots based on the mRNA technology used by both Moderna and Pfizer-BioNTech in preventing Covid-19 continue to outweigh the risks, regulators in the US, the European Union and the World Health Organisation have said.
Data suggests reported cases of rare heart inflammation are relatively higher after Moderna’s vaccine compared with the 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 with 100 micrograms in the Moderna vaccine.
Data from one of two US vaccine safety monitoring databases has also suggested that Moderna’s vaccine may carry a higher risk of myocarditis among young people.
Read more: Moderna may be superior to Pfizer against Delta; breakthrough odds rise with time
The vaccine is not approved for people under age 18 in the US.
Norway already recommends the Cominarty vaccine to minors and said on Wednesday that it was reiterating this.
“Men under the age of 30 should also consider choosing Cominarty when they get vaccinated,” head of infection control Geir Bukholm, from the Norwegian Institute of Public Health, said in a statement.
The EMA approved the use of Comirnaty in May, while Spikevax was given the nod for children aged over 12 years in July.
It referred to data from a 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 they now recommended the Comirnaty vaccine, from Pfizer-BioNTech, instead.
The Danish Health Authority said it had made the decision even as “heart inflammation is an extremely rare side effect that often has a mild course and goes away on its own”.
