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Sunday, 06 July 2025
Posted 29 October 2024 PM
The TGA has strengthened the label of GSK's shingles vaccine Shingrix to warn of the "very rare risk" of Guillain-Barre syndrome (GBS) following vaccination.
The Shingrix Product Information (PI) already contained information about a post-marketing observational study in people aged 65 years and over, which found an increased risk of GBS (estimated at three excess cases per million doses administered) in the 42 days following vaccination.
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