Nordic Nations Suspend Use of Moderna COVID Shot Over Heart Inflammation Concerns
Following reports of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) in young adults after receiving Moderna/NIAID’s experimental messenger RNA (mRNA) COVID-19 biologic known as “Spikevax,” the governments of Denmark, Norway and Sweden have suspended the shot or will not make it available for people under 30 years of age (in Norway and Sweden) and under 18 years of age (in Denmark). The restrictions were announced on Oct. 6, 2021.1 2 3 4 5
The government of Finland followed suit on Oct. 7 with its own suspension of the Spikevax for males under 30 years of age.1 3 4 5 Additionally, on Oct. 8, the government of Iceland entirely halted use of the Spikevax for everyone in that country. Iceland’s chief epidemiologist, Þórólfur Guðnason, said that his
government’s decision was due to “the increased incidence of myocarditis and pericarditis after vaccination with the Moderna vaccine, as well as with vaccination using Pfizer/BioNTech.”1 6 7 8Nordic Study Found Higher Risk of Myocarditis and Pericarditis in Young Men After Getting Spikevax
The restrictions on Spikevax were, at least in part, an outgrowth of a Nordic study led by Sweden’s Public Health Agency and involving Denmark, Finland and Norway that “found that men under the age of 30 who received Moderna Spikevax had a slightly higher risk than others of developing myocarditis,” said Mika Salminen, PhD, director of the Finnish Institute for Health and Welfare (THL) in Helsinki. The study, which has been sent to the European Medicines Agency (EMA) for its assessment, will reportedly be published within the next few months.1 3 5 9
“The Nordic registry study looking at the incidence of myocarditis and pericarditis has not been completed—and therefore hasn’t been published and final conclusions cannot be drawn,” Dr. Salminen cautioned.3
A spokesperson for the EMA stated:
Further evaluation of the data are required. EMA’s safety committee (PRAC) will assess the new data to determine whether there is a need to update current advice in the product information for the vaccines.3
EMA Advisory Panel Also Found Higher Risk of Heart Inflammation After mRNA COVID Shots
In July, the PRAC (Pandemic Response Accountability Committee) concluded that myocarditis and pericarditis can occur in rare cases after administering both Spikevax and Pfizer/BioNTech’s mRNA Comirnaty COVID biologic and recommended listing these conditions as new side effects in the product information inserts for the shots. The conclusion was based on a review of 145 cases of myocarditis in the European Economic Area (EEA) among people who had been given Comirnaty and 19 cases of among people who had received Spikevax. The committee also reviewed 138 cases of pericarditis among people who had been given Comirnaty and 19 cases among people who had received Spikevax.10
Just a month earlier, on June 23, the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention determined that there was a “likely association” between reported cases of myocarditis and pericarditis following vaccination with Comirnaty and Spikevax. The U.S. Food and Drug Administration (FDA) subsequently added a warning to the product information inserts for both biologics.11 12
Israeli health officials had also come up with a similar conclusion three weeks earlier regarding Comirnaty and dozens of cases of myocarditis in Israel, mostly in males between the ages of 16-30 years. This conclusion was based on a study conducted by public health experts from Israel’s Department of Epidemiology and National Center for Disease Control and representatives from Tel Aviv University, Haifa University and the Technion institute.11
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