Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology.

ABSTRACT: A diligent, systematic, regular review of aggregate safety data is essential, particularly early after vaccine introduction, as this is when safety signals not identified during clinical development may emerge. In October 2017, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommended the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) as the preferred vaccine for preventing herpes zoster (HZ) and related complications in immunocompetent adults aged ≥ 50 years. Subsequently, GSK experienced an unprecedented high demand for RZV. In this methodology paper, we summarize the enhanced measures undertaken to assess RZV safety during its early post-marketing experience in the USA, Canada and Germany. In addition to the routine signal-det

SUBMITTER: Tavares-Da-Silva F 

PROVIDER: S-EPMC7686206 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature