The U.S. Food and Drug Administration (FDA) has announced that respiratory syncytial virus (RSV) vaccines from both GSK and Pfizer will be required to carry warnings regarding an increased risk of developing a rare neurological disorder. This regulatory action will impact the labeling of these key vaccine products.
The new warnings are a result of ongoing safety monitoring by the FDA. While the specific neurological disorder was not detailed in the announcement, the requirement for such warnings can influence public health recommendations and patient decisions regarding vaccination.
This development introduces a new safety consideration for healthcare providers and patients when evaluating RSV vaccination. The impact on vaccine uptake and market dynamics for Pfizer's Abrysvo will be closely monitored following the implementation of these warnings.
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