FDA Intensifies Myocarditis Warnings on COVID-19 Vaccines Amid Debate
The FDA has expanded warnings for Pfizer and Moderna COVID-19 vaccines regarding the risk of myocarditis, primarily among young men. Although the CDC's data suggested no increased risk, new advisors argue over vaccine policies. Experts criticize the FDA's approach, recommending instead to assess individual risk factors for myocarditis.
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The Food and Drug Administration (FDA) has expanded warnings regarding myocarditis risk linked to Pfizer and Moderna's COVID-19 vaccines. This rare heart inflammation, predominantly affecting young men, has raised concerns since vaccines rolled out in 2021. The updated labels now point to a risk rate of eight cases per one million in recipients aged six months to 64 years.
Despite incongruities with the CDC's past findings showing no increased risk, new advisors appointed by Health Secretary Robert F Kennedy Jr. are debating the vaccine's continued usage among critical groups. The advisory shuffle follows Kennedy's abrupt dismissal of previous CDC panel members, replaced by some with anti-vaccine viewpoints.
The FDA's recent actions, including restricting annual shots to seniors, have been met with criticism from experts who see the approach as misguided. Dr. Robert Morris suggests focusing on predicting and mitigating individual risks rather than blanket label changes. The debate underscores ongoing tensions surrounding vaccine policies during the pandemic.
(With inputs from agencies.)
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