Bachmann Michelle, Gültekin Nejla, Stanga Zeno, Fehr Jan S, Ülgür Ismail I, Schlagenhauf Patricia
Department of Global and Public Health, Epidemiology, Biostatistics and Prevention Institute, WHO Collaborating Centre for Travellers' Health, Centre of Competence for Military Medicine Biology, University of Zürich, Switzerland.
Swiss Armed Forces, Medical Services, Ittigen, Bern, Switzerland.
New Microbes New Infect. 2024 Dec 6;63:101551. doi: 10.1016/j.nmni.2024.101551. eCollection 2025 Feb.
The rapid development and distribution of mRNA COVID-19 vaccines has been essential in containing the SARS-CoV-2 epidemic around the globe. For ongoing and future immunization campaigns globally, there is a need to evaluate the impact of population demographics such as age and sex, on vaccine efficacy and safety.
This systematic review (PROSPERO ID CRD42023328245) conducted according to PRISMA guidelines evaluates the impact of age and sex on the safety and efficacy of the mRNA COVID-19 vaccinations administrated in 15 studies that were chosen according to strict criteria. The ROBIS tool was applied to evaluate the robustness and the quality of the studies included in the review.
After screening, 15 studies satisfied the inclusion criteria. The results showed that the COVID-19 mRNA vaccines typically elicit robust immune responses, and that younger people have higher antibody levels. Comparing the sexes reveals that higher immunological responses were induced in females, and mild to moderate adverse effects (such as injection site discomfort, exhaustion, and headaches) were also more frequently reported in women. Despite these variations, COVID-19 vaccines have been found to be safe to use across diverse populations, which supports their extensive use in public health initiatives.
Our results suggests that tailored vaccination may achieve maximum effectiveness and better tolerability depending on age and sex. Currently study results are rarely stratified by age and sex and this is a deficit in clinical trial publications. More research is needed to elucidate the biological mechanisms underlying the variations in vaccine responses according to age and sex.
新型冠状病毒肺炎（COVID-19）mRNA疫苗的快速研发和分发对于全球控制严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫情至关重要。对于全球正在进行的和未来的免疫接种活动，有必要评估年龄和性别等人群统计学特征对疫苗效力和安全性的影响。
本系统评价（国际前瞻性系统评价注册库编号CRD42023328245）按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行，评估年龄和性别对15项根据严格标准选取的研究中所接种的COVID-19 mRNA疫苗的安全性和效力的影响。应用研究偏倚风险评估工具（ROBIS）评估纳入本评价的研究的稳健性和质量。
筛选后，15项研究符合纳入标准。结果显示，COVID-19 mRNA疫苗通常能引发强烈的免疫反应，且年轻人的抗体水平更高。比较不同性别发现，女性诱导产生的免疫反应更高，女性报告的轻至中度不良反应（如注射部位不适、疲劳和头痛）也更频繁。尽管存在这些差异，但已发现COVID-19疫苗在不同人群中使用是安全的，这支持了其在公共卫生举措中的广泛应用。
我们的结果表明，根据年龄和性别进行定制化接种可能会实现最大效力和更好的耐受性。目前的研究结果很少按年龄和性别分层，这是临床试验出版物中的一个不足。需要更多研究来阐明疫苗反应因年龄和性别而异的生物学机制。
