US FDA advisers weigh heart risk on COVID Modern vaccine for young men

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Moderna’s COVID-19 vaccine may have a higher risk of heart inflammation in young men than the Pfizer / BioNTech vaccine, according to data presented Tuesday to U.S. Food and Drug Administration advisers who weigh its use for people from 6 to 17 years.

An FDA official told the panel that while the data showed a higher risk for taking Moderna, the findings were inconsistent in several safety databases and were not statistically significant. which means they could be due to chance.

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The overall incidence is relatively rare and the vast majority of those suffering from the side effect recover completely, but a comparison showed that the risk of myocarditis and pericarditis in young men aged 18 to 39 years was 1.1 to 1.5 times larger after the Modern Injection, the FDA said in its filing, citing data from three U.S. vaccine safety databases.

Data from a U.S. Centers for Disease Control and Prevention database showed 4.41 cases of excess heart inflammation per 100,000 people who received the Pfizer / BioNTech vaccine in people with between 18 and 39 years compared to 6.27 cases in excess per 100,000 of Moderna.

There has long been concern that the Modern Vaccine, which is given at a higher dose than Pfizer / BioNtech, could cause myocarditis and pericarditis at higher rates.

Some European countries have restricted the use of the Moderna vaccine to younger age groups after surveillance suggested it was linked to an increased risk of heart inflammation, and the FDA delayed its review of the Modern 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 in adolescents and young men.

External experts are considering the data before deciding whether to recommend the Moderna vaccine for children and adolescents aged 6 to 17 years. The Pfizer vaccine is now licensed for children from 5 years of age.

(Manas Mishra report in Bangalore; Additional report by Michael Erman in New Jersey; Jason Neely and Bill Berkrot edition)

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