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The Novavax shot’s product label for the U.S. market warned against injecting it to people with a history of allergic reactions to any of its components. But even before it was granted EUA in July, staffers at the FDA pointed out that the vaccine increased the risk of myocarditis.

In documents released June 3, staff members at the regulator cited four events of myocarditis – inflammation of the heart muscle – that occurred during clinical trials of the vaccine. Novavax conducted trials of its sub-unit protein vaccine on almost 30,000 patients between December 2020 and September 2021.

“These events raise the concern for a causal association with this vaccine, similar to the association documents with mRNA COVID-19 vaccines. Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis heart lining inflammation … associated with the vaccine,” they wrote.

“Further evaluation is needed to inform the risk of myocarditis and pericarditis, and their outcomes, as additional data emerge over time.”

https://www.brighteon.com/2073....4703-c553-409e-92a6-

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