Review of the initial post-marketing safety surveillance for the recombinant zoster vaccine.

Vaccine(2020)

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摘要
•The adjuvanted recombinant zoster vaccine (RZV) is licensed for herpes zoster prevention in ≥50-year-olds.•Post-licensure spontaneous safety reports received up to February 10, 2019 were reviewed.•Of 15,638 reports, most were non-serious, from US, and associated with known vaccine reactogenicity.•No unexpected reporting patterns were detected overall.•The RZV safety profile was consistent with that observed in clinical trials.
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关键词
ACIP,AE,AESI,CD,gE,GBS,GSKMQ,HCP,HZ,ICH,MedDRA,O/E,pIMDs,RZV,SMQ,TTO,US,VAERS,VZV,ZVL
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