Efficacy and safety of the recombinant zoster vaccine: A systematic review and meta-analysis

Abstract

In this systematic review with meta-analysis, the efficacy, effectiveness, and safety of the new GSK recombinant zoster vaccine (RZV) were assessed.Twenty three publications reporting on 14 studies were selected, including 2 pivotal RCTs in older immunocompetent adults (ZOE-50 and ZOE-70), 4 RCTs on immunocompromised patients (haematopoietic stem cell transplantation (HSCT), haematological malignancies, solid tumour, and renal transplantation), and 8 observational studies. Vaccine efficacy of RZV against herpes zoster (HZ) and postherpetic neuralgia (PHN) was very high in immunocompetent older adults (respectively 94% and 91.2% in adults ≥50 years and 91.3% and 88.8% in adults ≥70 years). However, the number needed to vaccinate (NNV) was relatively high (between 32 and 36 for HZ and between 261 and 335 for PHN). Slow waning of the vaccine efficacy has been described after a median follow-up of 10 years after vaccination. In patients after HSCT, vaccine efficacy of RZV against HZ was lower compared to immunocompetent adults (68.2%), while vaccine efficacy of RZV against PHN was similar (89.3%). Higher incidences of HZ and PHN in patients after HSCT resulted in higher absolute reduction of cases and lower NNV (respectively 10 and 115). Observational studies confirmed a good vaccine effectiveness, albeit lower than in RCTs (ranging between 70% and 85%). No safety signal was identified neither in RCTs with immunocompetent or immunocompromised adults nor in observational studies and post-marketing surveillance. Increased reactogenicity after RZV vaccination, limited in extent and duration, did not result in low second dose compliance.

Conclusion: Although vaccine efficacy in RCTs and effectiveness in the real world has been reported to be good, it needs to be stressed that high numbers of immunocompetent adults need to be vaccinated to prevent HZ and PHN. Due to higher incidence, more acceptable NNVs were calculated in immunocompromised adults after HSCT.

Fig. 1

Prisma Flow chart.

Fig. 2

Meta-analysis results on efficacy/effectiveness against HZ. References: Bastidas 2019 (1); Cunningham 2016 (2); Dagnew 2019 (3); Izurieta 2021 (4), Khan 2021 (5), Lal 2015 (6), Sun 2021 (US KPH) (7); Sun 2021 (US OLDW) (8). CI: confidence interval, HSCT: hematopoietic stem cell transplantation, HM: haematological malignancies, IBD: inflammatory bowel disease, KPH: Kaiser Permanente Hawaii, OLDW: OptmumLabs Data Warehouse, Total: total follow-up time in person-years.