COPENHAGEN, Denmark (AP) – Swedish health authorities on Wednesday suspended the use of the Mother’s COVID-19 vaccine for those aged 30 and younger and said that the move was made by precautionary measures.
The reason for the break is “signals of an increased risk of side effects such as inflammation in the heart muscle or heart sac” – the double-walled sac that contains the heart and the roots in the main vessels, says the Public Health Agency in a statement. “The risk of being affected is very small.”
Anders Tegnell, Sweden’s chief epidemiologist, said that they “follow the situation closely and act quickly to ensure that vaccinations against COVID-19 are always as safe as possible and at the same time provide effective protection” against the disease.
In July, the European Medicines Agency recommended approving the Mother’s COVID-19 vaccine for children aged 12 to 17, the first time the shot has been approved for people under 18 years of age.
The mother’s vaccine was given the green light for use in all 18 years and older in 27 EU countries in January. It has also been licensed in countries such as the United Kingdom, 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 one approved for children under 18 in Europe and North America.
Hundreds of millions of Modern doses have already been administered to adults. In a study of more than 3,700 children aged 12 to 17, the vaccine triggered the same signs of immune protection, and no COVID-19 diagnoses occurred in the vaccinated group compared with four cases among those who received dummy shots.
Sore arms, headaches and fatigue were the most common side effects in young vaccine recipients, the same as in adults.
However, US and European regulators warn that both Modern and Pfizer vaccines appear to be linked to a rare reaction in teens and young adults – chest pain and heart inflammation.
The Swedish health authorities said that the heart symptoms “usually disappear on their own”, but they must be assessed by a doctor. The conditions are most common among young men, in connection with, for example, viral infections such as COVID-19. In 2019, approximately 300 people under the age of 30 were treated in hospital with myocarditis.
Data indicate an increased incidence also in connection with vaccination against COVID-19, mainly in adolescents and young adults and mainly in boys and men.
New preliminary Nordic analyzes indicate that the connection is particularly clear when it comes to Moderna’s vaccine, especially after the second dose, the agency said.
“The increase in risk is seen within four weeks after vaccination, mainly within the first two weeks,” it said.
The Swedish agency said that the vaccine from Pfizer is recommended for these age groups instead. The decision to discontinue the Moderna vaccine is valid until 1 December.
In Denmark, people under the age of 18 will not be offered the Moderna vaccine as a precaution, the Danish health authority said on Wednesday. It said that data, collected from four Nordic countries, show that there is a suspicion of an increased risk of heart inflammation when vaccinated with Modern shots, even though the number of cases of heart inflammation is still very low.
The preliminary data from the Nordic study have been sent to the European Medicines Agency’s adverse reaction committee and will now be assessed.
The study was conducted by the Danish National Serum Institute – 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 Welfare (THL) in Finland. The final results were expected in about a month, said the Danish official.
In Denmark, children and young people aged 12-17 have primarily been invited 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, not least given that it is for this vaccine that the largest amount of data from use is available for children and young people, especially from the United States and Israel,” says Bolette Soeborg from the state health service.
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