Ekkehard Beck, Mihaela Georgieva, Wei-Jhih Wang, Andres Gomez-Lievano, Hongjue Wang, Yipeng Gao, Hagit Kopel, Mary Bausch-Jurken, Oscar Patterson-Lomba, Fan Mu, Eric Wu, Nicolas VandeVelde
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However, there are no head-to-head trials comparing mRNA-1283 and the BNT162b2 vaccine.</p><p><strong>Objective: </strong>To indirectly compare the effectiveness of mRNA-1283 and BNT162b2 against symptomatic COVID-19 among adults in the U.S.</p><p><strong>Methods: </strong>A targeted literature review was conducted to identify relevant studies comparing the mRNA-1273 and BNT162b2 bivalent vaccines. A real-world evidence (RWE) study by Kopel et al. (2023) assessing the relative vaccine effectiveness (rVE) of mRNA-1273 vs. BNT162b2, was selected for an indirect treatment comparison (ITC) against the NextCOVE trial using the Bucher method. Analyses were stratified by age group, and sensitivity analyses were conducted using alternative outcome definitions.</p><p><strong>Results: </strong>Despite differences between NextCOVE and the Kopel study, comparability assessments supported a robust ITC. 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引用次数: 0
摘要
背景：COVID-19继续造成重大健康负担，特别是在老年人中。mRNA-1283是为增强免疫应答而开发的新一代新冠病毒mRNA疫苗。比较mRNA-1273和mRNA-1283疫苗双价版本的NextCOVE 3期试验的结果最近已可用。然而，目前还没有对mRNA-1283和BNT162b2疫苗进行正面比较的试验。目的：间接比较mRNA-1283和BNT162b2对美国成人症状性COVID-19的有效性。方法：通过有针对性的文献综述，确定mRNA-1273和BNT162b2双价疫苗的相关研究。Kopel等人（2023）的一项真实世界证据（RWE）研究评估了mRNA-1273与BNT162b2的相对疫苗有效性（rVE），采用Bucher方法与NextCOVE试验进行了间接治疗比较（ITC）。分析按年龄组分层，并使用不同的结果定义进行敏感性分析。结果：尽管NextCOVE和Kopel研究之间存在差异，但可比性评估支持稳健的ITC。在年龄≥18岁的参与者中，mRNA-1283与BNT162b2对症状性COVID-19的间接rVE为15.3% （95% CI: 4.7-24.8%, p = 0.006）。对于≥65岁的成年人，rVE为22.8% （95% CI: 3.7-38.1%, p = 0.022）。不同结果定义的敏感性分析支持这些估计。结论：该分析提供了一致且具有统计学意义的证据，表明下一代mRNA-1283疫苗比BNT162b2更有效地预防症状性COVID-19，且在≥65岁的人群中效果最大。敏感性分析的一致结果强调了研究结果的稳健性，为决策者、提供者和支付方的疫苗接种决策提供了重要证据。
Indirect comparison of the relative vaccine effectiveness of mRNA-1283 vs. BNT162b2 vaccines against symptomatic COVID-19 among US adults.
Background: COVID-19 continues to pose a significant health burden, particularly among older adults. mRNA-1283 is a next-generation COVID-19 mRNA vaccine developed to enhance immune response. Findings from the Phase 3 NextCOVE trial comparing bivalent versions of mRNA-1273 and mRNA-1283 vaccines have recently become available. However, there are no head-to-head trials comparing mRNA-1283 and the BNT162b2 vaccine.
Objective: To indirectly compare the effectiveness of mRNA-1283 and BNT162b2 against symptomatic COVID-19 among adults in the U.S.
Methods: A targeted literature review was conducted to identify relevant studies comparing the mRNA-1273 and BNT162b2 bivalent vaccines. A real-world evidence (RWE) study by Kopel et al. (2023) assessing the relative vaccine effectiveness (rVE) of mRNA-1273 vs. BNT162b2, was selected for an indirect treatment comparison (ITC) against the NextCOVE trial using the Bucher method. Analyses were stratified by age group, and sensitivity analyses were conducted using alternative outcome definitions.
Results: Despite differences between NextCOVE and the Kopel study, comparability assessments supported a robust ITC. Among participants ≥18 years of age, the indirect rVE of mRNA-1283 vs. BNT162b2 against symptomatic COVID-19 was 15.3% (95% CI: 4.7-24.8%, p = 0.006). For adults ≥65 years of age, the rVE was 22.8% (95% CI: 3.7-38.1%, p = 0.022). Sensitivity analyses with alternative outcome definitions supported these estimates.
Conclusion: This analysis provides consistent and statistically significant evidence indicating the next-generation mRNA-1283 vaccine is more effective in preventing symptomatic COVID-19 than BNT162b2, with the largest effect in individuals aged ≥65. Consistent results across sensitivity analyses underscore the robustness of the findings, offering important evidence to inform vaccination decisions by policymakers, providers, and payers.
期刊介绍：
Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance
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