Breaking Moderna wins full FDA approval for COVID shot in children as young as six months
BREAKING: Moderna’s mRNA COVID shot — linked to heart damage, brain damage, cancer, and death — just got FULL FDA APPROVAL for “at-risk” children as young as 6 months. This is gravely worrisome. Our regulatory agencies are still completely compromised.
Moderna wins full FDA approval for COVID shot in children
Moderna (NASDAQ:MRNA) announced on Thursday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its Spikevax COVID-19 vaccine to allow its use in children as young as six months.
Clearing the company’s supplemental Biologics License Application for Spikevax, the FDA has approved the messenger RNA-based shot for those aged six months to 11 years who are at increased risk for COVID-19 disease, the company said.
The blockbuster shot was previously available for children under the FDA’s Emergency Use Authorization (EUA).
The company added that Spikevax will be made available for eligible children in time for the 2025-2026 respiratory virus season.
“Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization,” CEO Stéphane Bancel said, adding, “We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease.”
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