Sweden suspended Moderna vaccine application for under 30s

Swedish health officials on Wednesday suspended use of Moderna’s COVID-19 vaccine for those under 30, claiming the measure was taken as a precaution.

The reason for the break is “Signs of an increased risk of side effects such as inflammation of the heart muscle or pericardium”: the double-walled sac that contains the heart and roots of major vessels, the Swedish Public Health Agency said in a report. “The risk of being affected is very low.”

Anders Tegnell, Sweden’s chief epidemiologist, said they are “closely monitoring the situation and acting quickly to ensure that COVID-19 vaccines are still as safe as possible while providing effective protection” against disease.

In July, The European Medicines Agency has recommended that Moderna’s COVID-19 vaccine be authorized for children aged 12 to 17, the first time that the injection is authorized for people under the age of 18.

Moderna’s vaccine was given the green light for use in anyone 18 years of age or older in the 27 countries of the European Union in January. It has also been licensed in countries like Britain, Canada, and the United States, but so far its use has not spread 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 appeared in the group vaccinated against four cases among those who received sham injections.

Arm pain, headaches and fatigue were the most common side effects among young people who received the vaccine, the same as in adults.

US and European regulators, however, warn 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 said heart symptoms “usually go away on their own”, but they must be evaluated by a doctor. The conditions are more common in young men, linked, for example, to viral infections like COVID-19. In 2019, around 300 people under the age of 30 received hospital treatment for myocarditis.

The data indicate a higher incidence also with regard to vaccination against COVID-19, mainly in adolescents and young adults and mainly in children and men.

New preliminary northern 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 recommended for these age groups.. Your decision to stop 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 European Medicines Agency and now they will 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 Swedish Medicines Agency, the Norwegian National Institute of Public Health and the Institute for Health and well-being (THL) in FinnishTo. Final results were expected in about a month, the Danish official said.

In Denmark, it was mainly children and young people between the ages of 12 and 17 who were asked to receive the COVID-19 vaccine from Pfizer / BioNTech.

“On the basis of 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 most data on the use in children and young people. , especially from the United States and Israel, ”said Bolette Soeborg of the government health agency.

(with AP information)

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