GSK (GSK) and Pfizer (PFE) vaccines for respiratory syncytial virus, or RSV, will carry warnings that they can increase the risk of developing a rare neurological disorder, Reuters writes. The FDA conducted a post-marketing trial that suggested an increased risk of Guillain-Barre syndrome 42 days following vaccination, although the available evidence was insufficient to establish a causal relationship. The risks flagged in the prescribing information of GSK’s Arexvy and Pfizer’s Abrysvo are not the regulator’s strictest “boxed” warnings, Reuters says.
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