The U.S. Food and Drug Administration (FDA) said on Tuesday that product labels for respiratory syncytial virus (RSV) vaccines will carry a safety warning, indicating they may increase the risk of developing a rare neurological disorder, primarily Guillain-Barré Syndrome (formerly known as GBS).InIn the clinical trial of Arexvy, one participant developed GBS after vaccination, while in the trial of Abrysvo, one participantAnother participant contracted GBS, and yet another was diagnosed with a variant of the disease.Post-marketing surveillance data of two RSV vaccines by the regulatory agency indicate an increased risk of GBS within 42 days after RSV vaccination. However, the FDA stated that the current evidence is insufficient to establish a causal relationship.By doing soPurposeYes：Inform the public and healthcare providers,FDA has requested and approved Pfizer's Abrysvo andProduced by GSKSafety Labeling Changes for Arexvy Prescribing Information. The following language is included in the "Warnings and Precautions" section:Abrysvo: The results of a post-marketing observational study indicate that, following vaccinationThe risk of GBS increases within 42 days after Abrysvo vaccination.Arexvy: The results of a post-marketing observational study indicate that, following vaccinationWithin 42 days after receiving the Arexvy vaccine, suffering fromIncreased risk of GBS.The risks flagged in the prescribing information for GSK's Arexvy and Pfizer's Abrysvo are not the most stringent "black box" warnings from regulatory agencies. GBS is a rare condition where the body's immune system damages nerve cells, causing muscle weakness and sometimes even paralysis.Last year, experts and consultants from the US CDC postponed the approval.Use of Arexvy in the 50-59 Age Group, they also markedThe risk of GBS.
Source of Information:
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-guillain-barre-syndrome-gbs-warning-prescribing-information-rsv-vaccines-abrysvo-and
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