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Hey, good morning. Today, we see CBER suspend the license for a chikungunya vaccine, look at a push to recall a safety and efficacy study for the antidepressant Paxil, and more.
FDA pulls license for chikungunya vaccine
The Food and Drug Administration’s Center for Biologics Evaluation and Research has suspended the biologics license for Ixchiq, a live-attenuated chikungunya vaccine made by Valneva that was cleared under accelerated approval less than two years ago. The move follows mounting reports of “serious safety concerns” related to the vaccine, which it says cause chikungunya-like illness in some people who received the vaccine.
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