Related GBS Postmarketing Evidence

Risks & contraindications

Evidence quality

Where it comes from

Other

Highlighted claims

• Labels for adjuvanted RSVPreF3 and RSVPreF vaccines were updated with safety information about a potential increased GBS risk within 42 days after vaccination. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• The Medicare self-controlled case series included more than 3.2 million vaccinated beneficiaries aged 65 years and older by the end of the 2023-2024 respiratory virus season. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• The Medicare study reported an excess risk of 6.5 GBS cases per 1 million people vaccinated with adjuvanted RSVPreF3 within 42 days after vaccination. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• A separate FDA CBER postmarketing active surveillance study preceded the GBS label update. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
• The article states that continued investigation is needed to build conclusive evidence on GBS risk. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study