JAKARTA - COVID-19 vaccine manufacturer Moderna said it was aware of Sweden and Denmark's decision to temporarily stop using their vaccine for young people.
Sweden and Denmark said on Wednesday that they were discontinuing use of Moderna's COVID-19 vaccine for younger age groups after reports of rare possible cardiovascular side effects.
A Moderna spokesperson said in an email that the company is aware of decisions by regulators in Denmark and Sweden to stop using its vaccine in younger individuals because of the risk of myocarditis (inflammation of the heart muscle) and/or rare pericarditis.
"These are usually mild cases and individuals tend to recover within a short time after standard care and rest. The risk of myocarditis increases substantially for those who contract COVID-19, and vaccination is the best way to protect against it," the spokesperson said, citing Reuters on Oct. 7.
According to a study in the United States that has not undergone peer review, young men under 20 years of age are six times more likely to develop myocarditis after contracting COVID-19 than those who have been vaccinated.
Previously, Sweden's health agency said it would stop using injections for people born in 1991 and under, as data showed an increase in myocarditis and pericarditis among vaccinated adolescents and young adults. The condition involves inflammation of the heart or its lining.
"The relationship is very clear when it comes to the Spikevax Moderna vaccine, especially after the second dose," the health agency said, adding that the risk of exposure was very small.
Meanwhile, Denmark said that despite using Pfizer's vaccine as the first choice for people aged 12-17, it decided to stop giving Moderna vaccine to people under 18 in accordance with the precautionary principle.
"In preliminary data, there is a suspicion of an increased risk of cardiac inflammation, when vaccinated with Moderna," the Danish Health Authority said in a statement.
"This refers to data from an unpublished Nordic study, which will now be sent to the European Medicines Agency (EMA) for further assessment. Final data is expected within a month," he added.
Sweden and Denmark said they now recommend the Comirnaty vaccine, from Pfizer/BioNTech, instead.
The Danish Health Authority said it had made a decision, even as heart inflammation is a very rare side effect that is often mild and goes away on its own.
The EMA safety committee concluded in July that inflammatory cardiac conditions can occur in very rare cases after vaccination with Comirnaty or Spikevax, more often in younger men after the second dose.
While the benefits of injections based on the so-called mRNA technology used by Moderna and Pfizer-BioNTech in preventing COVID-19, however, outweigh the risks, say regulators in the United States, the European Union and the World Health Organization (WHO).
The data show relatively higher reported cases of rare heart inflammation after the Moderna vaccine compared to the Pfizer injection, Canadian health officials said last week.
Although both vaccines are based on mRNA technology, the Pfizer injection contains 30 micrograms of vaccine per dose compared to 100 micrograms in the Moderna vaccine.
Data from one of two US vaccine safety monitoring databases also suggest that the Moderna vaccine may carry a higher risk of myocarditis among young people. This vaccine is not approved for people under the age of 18 in the United States.
Meanwhile, Norway has recommended the Cominarty vaccine to minors and said on Wednesday it was repeating this.
"Men under the age of 30 should also consider choosing Cominarty when they are vaccinated," Geir Bukholm, head of infection control at the Norwegian Institute of Public Health, said in a statement.
Separately, a Finnish health official said Finland was expected to publish a decision on Thursday.
Please note, EMA approved the use of Comirnaty (Pfizer) in May. Meanwhile, Spikevax (Moderna) was approved for children over 12 in July.
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