An FDA official told the panel that while the data showed a higher risk of taking Moderna, the findings were inconsistent with various security databases and were not statistically significant, meaning they could be due to luck.
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The overall incidence is relatively rare and the vast majority of those suffering from the side effect are fully recovered, but a comparison showed that the risk of myocarditis and pericarditis in young men aged 18-39 was 1.1 to 1.5 times higher after the Moderna vaccine. , the FDA said in its presentation, citing data from three vaccine safety databases in the US. Data from a U.S. Centers for Disease Control and Prevention database showed 4.41 cases of hyperinflammation per 100,000 people receiving the Pfizer / BioNTech vaccine in people ages 18-39 versus an additional 6.27 cases per 100,000 for Moderna. There have long been concerns that the Moderna vaccine, which is given at a higher dose than the Pfizer / BioNtech vaccine, may cause myocarditis and pericarditis at higher rates.
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Some countries in Europe have limited use of the Moderna vaccine for younger age groups as surveillance suggested it was associated with a higher risk of heart disease and the FDA delayed the revision of the Moderna vaccine to assess the risk of myocarditis. The FDA said data from European and Canadian regulators showed that the risk was 1.7 to 7.3 times higher for the Moderna vaccine than the Pfizer vaccine for teens and young men. External experts review the data before deciding whether to recommend the Moderna vaccine for children and adolescents aged 6-17. The Pfizer vaccine is already approved for children 5 years of age and older. (Report by Manas Mishra in Bengaluru; Additional Report by Michael Erman in New Jersey; Edited by Jason Neely and Bill Berkrot)
