Real-World Evidence for Regulatory Decisions: Concomitant Administration of Zoster Vaccine Live and Pneumococcal Polysaccharide Vaccine.
作者： Katia Bruxvoort , Lina S Sy , Yi Luo , Hung Fu Tseng
DOI: 10.1093/AJE/KWY076
关键词:
摘要: The US Food and Drug Administration is charged with expanding the use of real-world evidence for regulatory decisions. As a test case to support decisions, we present scenario concomitant vaccination zoster vaccine live (ZVL) 23-valent pneumococcal polysaccharide (PPSV23). prescribing information states that these vaccines should not be given concurrently, based on small trial using varicella virus antibody levels as correlate ZVL efficacy, even though protects against herpes via cell-mediated immunity. We conducted an observational cohort study involving more than 35,000 members Kaiser Permanente Southern California receiving PPSV23 versus prior ZVL. Occurrence was assessed through electronic health records from January 1, 2007, June 30, 2016. adjusted hazard ratio comparing incidence rates in 1.04 (95% confidence interval: 0.92, 1.16). This provides direct lack interference, relying occurrence rather intermediate marker Real-world essential regulators policy makers addressing evidentiary gaps regarding safety, effectiveness, compliance, interactions new recombinant vaccine.
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