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COPENHAGEN, Denmark – Swedish health authorities on Wednesday suspended the use of Moderna’s COVID-19 vaccine for children under 30, saying the move was taken as a precaution.
The reason for the pause is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” – the double-walled sac containing the heart and the roots of major vessels, said the Swedish Public Health Agency in a statement. declaration. “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.
In July, the European Medicines Agency recommended authorizing Moderna’s COVID-19 vaccine for children aged 12 to 17, the first time the vaccine has been authorized for people under the age of 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. To date, the Pfizer / BioNTech vaccine is the only vaccine 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 who 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 are warning, 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.
New preliminary Nordic analyzes indicate that 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, collected from four Nordic countries, 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 weak.
Preliminary data from the Nordic study has been sent to the Adverse Reactions Committee of the European Medicines Agency and will now be evaluated.
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 Medical Products Agency in Sweden, the National Institute of Public Health in Norway and the Institute for health and well-being (THL) in Finland. Final results were expected in about a month, the Danish official said.
In Denmark, children and young people between the ages of 12 and 17 have mainly been advised to receive the COVID-19 vaccine from Pfizer / BioNTech.
“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 in the United States and Israel, said Bolette Soeborg of the government health agency.
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Follow AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine
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