Respiratory syncytial virus (RSV), an important pathogen causing lower respiratory tract infections in the elderly, has been the subject of continuous research and development for the production of effective and safe vaccines, both domestically and internationally. To date, three RSV vaccines have been approved for use globally, two recombinant protein subunit vaccines and an mRNA vaccine. As vaccines with different functional mechanisms, their efficacy and safety have yet to undergo systematic comparison and evaluation.

In this study, we sought to compare differences in the efficacy and safety of these RSV mRNA and recombinant protein subunit vaccines.

Computerized searches of the Web of Science, PubMed, Cochrane Library, Embase, and Scopus databases were conducted for randomized controlled trials (RCT) on the implementation of RSV vaccines in the population, with the search period extending from the date of database establishment to May 2025. The trial group consisted of individuals who received an injection of the RSV vaccine, whereas the control group received injection of a control vaccine. Two researchers independently screened the literature, extracted the data, and evaluated the risk of bias in the studies. Data analysis was conducted using R 4.5.0 and RevMan 5.4.1 software, and the evidence level of outcome measures was evaluated using the GRADE standard.

In terms of vaccine efficacy, mRESVIA was found to have highest protective effect based on Bayesian network meta-analysis [OR (95%CI) =0.17(0.09-0.31)], followed by Arexvy [OR (95%CI) =0.21(0.16-0.29)]. However, among the three vaccines, the protective efficacy of Abrysvo was relatively lower [OR (95%CI) =0.42(0.32-0.56)]. From the perspective of the level of immunogenicity, an independent sample t-test was conducted on the geometric mean ratio of antibody titers (GMFR) induced by the Arexvy vaccine and mRESVIA with the results indicating that in the RSV-B subgroup, the GMFR of Arexvy was significantly higher than that of mRESVIA, and the difference was statistically significant (t=-2.550, P=0.019). From the perspective of safety, a comparison of risk differences (RD) in the reporting rate of local (injection site) pain occurrence revealed that there was no statistically significant difference among the vaccines (P>0.05); a comparison of relative risks in the reported rates of serious adverse reactions/death events also showed that there was no statistically significant difference among the vaccines (P>0.05). Furthermore, the GRADE classification results revealed that the rates of lower respiratory tract infections, geometric mean fold rise, geometric mean ratio, and reporting of local (injection site) pain were of high-quality evidence, whereas in contrast, the reporting of severe/death events was of low-quality evidence.

Compared with traditional recombinant protein subunit vaccines, mRESVIA, an emerging mRNA vaccine, was found to have superior protective efficacy, which can be attributed to its unique advantages. We accordingly believe that this vaccine has considerable potential for future development and market expansion, although its long-term efficacy and protective effects for specific populations necessitate further verification.

呼吸道合胞病毒（RSV）作为引起中老年人下呼吸道感染的重要病原体，国内外始终致力于研制出有效且安全的疫苗。截至目前，全球范围内共上市了三款RSV疫苗，其中包括两款重组蛋白亚单位疫苗与一款mRNA疫苗。作为两种不同技术路线的疫苗，其有效性、安全性尚缺乏系统对比与评价。

比较RSV mRNA疫苗与重组蛋白亚单位疫苗有效性和安全性。

计算机检索Web of Science、PubMed、Cochrane Library、Embase、Scopus数据库中有关RSV疫苗在人群中实施的随机对照试验（RCT），试验组采用注射呼吸道合胞病毒疫苗人群，对照组采用注射对照疫苗人群，检索时限为建库至2025年5月，并由两名研究者独立筛选文献、提取资料并纳入研究的偏倚风险。采用R 4.5.0、RevMan 5.4.1软件进行数据分析，并采用GRADE标准评价结局指标的证据等级。

从疫苗效力来看，贝叶斯网状Meta分析中mRESVIA显示出最高的保护效力（OR=0.17，95%CI=0.09~0.31），其次是Arexvy（OR=0.21，95%CI=0.16~0.29），而Abrysvo的保护效力在三者中相对最低（OR=0.42，95%CI=0.32~0.56）。从免疫原性水平来看，对Arexvy疫苗与mRESVIA诱导产生的抗体几何平均滴度比值（GMFR）进行独立样本t检验，结果显示在RSV-B亚组中，Arexvy的GMFR高于mRESVIA（t=-2.550，P=0.019）。从安全性指标来看，对局部（注射部位）疼痛发生报告率进行风险差比较，结果显示疫苗间的差异无统计学意义（P>0.05）；对严重不良反应/死亡事件发生报告率进行相对危险度比较，疫苗间的差异无统计学意义（P>0.05）。GRADE分级结果显示，下呼吸道感染率、几何平均增长倍数、几何平均比值、局部（注射部位）疼痛发生报告率为高质量证据，严重不良反应/死亡事件发生报告率为低质量证据。

mRESVIA作为一种新兴mRNA疫苗，在前期临床试验中展现出优于传统重组蛋白亚单位疫苗的保护效力，但其长期保护性及特殊人群保护尚待进一步研究。