Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Acumen LLC, Burlingame, California, USA.
Clin Infect Dis. 2021 Sep 15;73(6):941-948. doi: 10.1093/cid/ciab125.
Shingrix (recombinant zoster vaccine) was licensed to prevent herpes zoster, dispensed as 2 doses given 2-6 months apart among adults aged ≥50 years. Clinical trials yielded efficacy of >90% for confirmed herpes zoster, but post-market performance has not been evaluated. Efficacy of a single dose and a delayed second dose and efficacy among persons with autoimmune or immunosuppressive conditions have not been studied. We aimed to assess post-market vaccine effectiveness of Shingrix.
We conducted a cohort study among Medicare Part D community-dwelling beneficiaries aged >65 years. Herpes zoster was identified using a medical office visit diagnosis with treatment, and postherpetic neuralgia was identified using a validated algorithm. We used inverse probability of treatment weighting to improve cohort balance and marginal structural models to estimate hazard ratios.
We found a vaccine effectiveness of 70.1% (95% confidence interval [CI], 68.6-71.5) and 56.9% (95% CI, 55.0-58.8) for 2 and 1 doses, respectively. The 2-dose vaccine effectiveness was not significantly lower for beneficiaries aged >80 years, for second doses received at ≥180 days, or for individuals with autoimmune conditions. The vaccine was also effective among individuals with immunosuppressive conditions. Two-dose vaccine effectiveness against postherpetic neuralgia was 76.0% (95% CI, 68.4-81.8).
This large real-world observational study of the effectiveness of Shingrix demonstrates the benefit of completing the 2-dose regimen. Second doses administered beyond the recommended 6 months did not impair effectiveness. Our effectiveness estimates were lower than the clinical trials estimates, likely due to differences in outcome specificity.
欣立泽（重组带状疱疹疫苗）获许可用于预防带状疱疹，在年龄≥50 岁的成年人中，每 2-6 个月接种 2 剂。临床试验表明，其对确诊带状疱疹的有效性超过 90%，但尚未评估上市后的表现。尚未研究单剂和延迟第二剂的效果以及自身免疫或免疫抑制人群的效果。我们旨在评估欣立泽上市后的疫苗有效性。
我们在 Medicare Part D 社区居住的≥65 岁受益人群中开展了一项队列研究。使用有治疗的医疗就诊诊断带状疱疹，使用经过验证的算法确定带状疱疹后神经痛。我们使用治疗的逆概率加权来改善队列平衡，并使用边际结构模型估计风险比。
我们发现，2 剂和 1 剂的疫苗有效性分别为 70.1%（95%置信区间[CI]，68.6-71.5）和 56.9%（95% CI，55.0-58.8）。对于年龄>80 岁、第二剂在≥180 天内接种或自身免疫人群，2 剂疫苗的有效性没有显著降低。疫苗对免疫抑制人群也有效。2 剂疫苗预防带状疱疹后神经痛的有效性为 76.0%（95% CI，68.4-81.8）。
这项大规模真实世界观察性研究表明欣立泽的有效性获益于完成 2 剂方案。超过推荐的 6 个月后接种第二剂不会影响其有效性。我们的有效性估计值低于临床试验估计值，可能是由于结局特异性的差异。
