Moderna’s COVID-19 vaccine has a higher risk of heart inflammation in younger men than Pfizer / BioNTech injections, according to data from a U.S. Food and Drug Administration adviser on Tuesday considering the use of the vaccine aged 6 to 17 years. There is a possibility.
FDA officials have shown to an expert panel that the data are at high risk of modeler shots, but the findings are inconsistent across the various safety databases, not statistically significant, and by chance. Said it could be.
The overall incidence is relatively rare and the majority suffering from side effects recover completely, but by comparison, the risk of myocarditis and pericarditis in young men aged 18-39 years is after a shot of Moderna. The FDA states that it was 1.1 to 1.5 times higher, the presentation quoting data from three US vaccine safety databases.
According to data from the US Center for Disease Control and Prevention database, there are 4.41 excess cardiac inflammation cases per 100,000 people aged 18-39 years old who received Pfizer / BioNTech shots, and 6.27 excess cases per 100,000 in Moderna. Shown.
There has long been concern that Moderna shots, given at higher doses than Pfizer / BioNTech shots, can cause a higher rate of myocarditis and pericarditis.
In some European countries, the use of Moderna vaccines for younger age groups has been restricted after surveillance suggests an increased risk of heart inflammation, and the FDA is to assess the risk of myocarditis. The review of the model nashot has been postponed.
According to FDA, data from European and Canadian regulators showed that in adolescents and young men, the risk of the Moderna vaccine was 1.7-7.3 times higher than that of the Pfizer vaccine.
External experts are reviewing the data before deciding whether to recommend the Moderna vaccine to children aged 6 to 17 and teens. The Pfizer vaccine has already been approved for children over the age of five.