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In neighboring Finland, authorities are expected to announce their decision on Thursday, according to Dr Hanna Nohynek, chief medical officer of the Finnish Institute of Health and Welfare, told local TV station YLE.
The three countries based their decision on an unpublished study with the Swedish Public Health Agency saying it reports “increased risk of side effects such as inflammation of the heart muscle or pericardium” – the double sac wall containing the heart and roots of the major vessels. He added: “The risk of being affected is very low.”
Anders Tegnell, Sweden’s chief epidemiologist, said they are “monitoring the situation closely and acting quickly to ensure that COVID-19 vaccinations are still as safe as possible and at the same time offer a effective protection “against disease.
Preliminary information from the Nordic study has been sent to the European Medicines Agency Adverse Reactions Committee for evaluation.
The study was conducted by the Statens Serum Institute of Denmark, a government agency that maps the spread of the coronavirus in the country; the Medicines Agency in Sweden; Norwegian National Institute of Public Health; and the Institute for Health and Welfare in Finland. Final results were expected in about a month, said Bolette Soeborg of the Danish government health agency.
In July, the European Medicines Agency recommended authorizing the Moderna vaccine for children aged 12 to 17, the first time the vaccine has been authorized for those under 18.
Moderna’s vaccine was given the green light for use in anyone 18 years of age and older in the European Union at 27 countries in January. It has also been licensed in countries like Britain, Canada, and the United States, but so far its use has not been extended to children. Canada has approved its use for those over 12 years old, while Pfizer is approved for children under 18 in Europe and North America.
Hundreds of millions of doses of Moderna have already been given to adults. In a study of more than 3,700 children aged 12 to 17, the vaccine elicited the same signs of immune protection, and no diagnosis of COVID-19 was made in the group vaccinated against four cases among those with received sham injections.
Sore arms, headaches and fatigue were the most common side effects in young people vaccinated, the same as in adults.
US and European regulators have warned, however, that the Moderna and Pfizer vaccines appear to be linked to a rare reaction in adolescents and young adults – chest pain and heart inflammation.
Swedish health officials have said heart symptoms “usually go away on their own,” but they need to be evaluated by a doctor. The conditions are most common in young men, for example linked to viral infections such as COVID-19. In 2019, around 300 people under the age of 30 received hospital treatment for myocarditis.
The data indicate an increased incidence also related to the COVID-19 vaccination, mainly in adolescents and young adults and mainly in boys and men.
Preliminary Nordic analysis indicates the link is particularly clear when it comes to Moderna’s vaccine, especially after the second dose, the agency said.
“The increased risk is seen within four weeks of vaccination, mainly in the first two weeks,” he said.
The Swedish agency said Pfizer’s vaccine is more recommended for these age groups. His decision to suspend the Moderna vaccine is valid until December 1.
In Denmark, people under 18 will not be offered the Moderna vaccine as a precaution, the Danish health authority said on Wednesday. He said the data shows that there is a suspicion of an increased risk of heart inflammation when vaccinated with Moderna injections, although the number of cases of heart inflammation remains very low.
In Norway, which is not a member of the EU, the Norwegian Institute of Public Health has urged young people under 30 to opt for the Pfizer vaccine “because of an increased risk of a rare side effect” with Moderna.
In Denmark, children and young people between the ages of 12 and 17 have mainly been advised to receive Pfizer’s COVID-19 vaccine.
“Based on the precautionary principle, in the future we will only invite children and young people to receive this vaccine, especially since it is for this vaccine that there is the greatest amount of data available. ‘use for children and youth, especially from the United States and Israel, Soeborg said.
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