Related GBS Postmarketing Evidence
The article states that continued investigation is needed to build conclusive evidence on GBS risk. The Medicare study reported an excess risk of 6.5 GBS cases per 1 million people vaccinated with adjuvanted RSVPreF3 within 42 days after v…
1 sources - 5 claims
The article states that continued investigation is needed to build conclusive evidence on GBS risk. 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. Labels for adjuvanted RSVPreF3 and RSVPreF vaccines were updated with safety information about a potential increased GBS risk within 42 days after vaccination. A separate FDA CBER postmarketing active surveillance study preceded the GBS label update.