U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men
June 14 (Reuters) - Moderna's COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer/BioNTech shot, according to data presented on Tuesday to U.S. Food and Drug Administration advisers weighing its use for those aged 6 to 17.
An FDA official told the expert panel that while the data showed a higher risk for the Moderna shot, the findings were not consistent across various safety databases and were not statistically significant, meaning they might be due to chance.
The overall incidence is relatively rare and the vast majority who suffer the side effect fully recover, but a comparison showed the risk of myocarditis and pericarditis in young males aged 18-39 was 1.1 to 1.5 times higher after the Moderna shot, the FDA said in its presentation, citing data from three U.S. vaccine safety databases.
Data from a U.S. Centers for Disease Control and Prevention database showed 4.41 excess heart inflammation cases per 100,000 who received the Pfizer/BioNTech shot in those aged 18-39 versus 6.27 excess cases per 100,000 for Moderna.
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