Children's Health Defense The FDA’s vaccine advisory committee will meet tomorrow to discuss concerns about the vaccine, which the agency fast-tracked in 2021. Meanwhile, trials for investigational RSV vaccines for babies and some children are now on hold.
Moderna halted its clinical trial of experimental mRNA vaccines for respiratory syncytial virus (RSV) in babies after the shots were linked to severe side effects.
The U.S. Food and Drug Administration (FDA) disclosed this week in a briefing document that rather than protecting babies as anticipated, the vaccine likely caused higher rates of severe RSV illness among the vaccinated babies enrolled in the Phase 1 clinical trials.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Thursday “to discuss considerations for RSV vaccine safety in pediatric populations” based on Moderna’s clinical trial data.
Although the FDA never cites Moderna by name in the document as the company that made the vaccine in question, the agency lists the investigational vaccines, mRNA-1345 and mRNA-1365, and describes trial outcomes.
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