Más-Bermejo Pedro I, Dickinson-Meneses Félix O, Almenares-Rodríguez Kenia, Sánchez-Valdés Lizet, Guinovart-Díaz Raúl, Vidal-Ledo María, Galbán-García Enrique, Olivera-Nodarse Yadira, Morgado-Vega Isabel, Dueñas-Carrera Santiago, Pujol Merardo, Hernández-Bernal Francisco, Limonta-Fernández Miladys, Guillén-Nieto Gerardo, Muzio-González Verena L, Ayala-Ávila Marta
Pedro Kourí Tropical Medicine Institute, Havana, Cuba.
National School of Public Health, Havana, Cuba.
Lancet Reg Health Am. 2022 Dec;16:100366. doi: 10.1016/j.lana.2022.100366. Epub 2022 Sep 24.
COVID-19 vaccines have proven safe and efficacious in reducing severe illness and death. Cuban protein subunit vaccine Abdala has shown safety, tolerability and efficacy (92·3% [95% CI: 85·7‒95·8]) against SARS-CoV-2 in clinical trials. This study aimed to estimate Abdala's real-world vaccine effectiveness (VE).
This retrospective cohort study in Havana analyzed Cuban Ministry of Public Health databases (May 12-August 31, 2021) to assess VE in preventing severe illness and death from COVID-19 (primary outcomes). Cox models accounting for time-varying vaccination status and adjusting by demographics were used to estimate hazard ratios. A subgroup analysis by age group and a sensitivity analysis including a subgroup of tested persons (qRT-PCR) were conducted. Daily cases and deaths were modelled accounting for different VE.
The study included 1 355 638 persons (Mean age: 49·5 years [SD: 18·2]; 704 932 female [52·0%]; ethnicity data unavailable): 1 324 vaccinated (partially/fully) and 31 433 unvaccinated. Estimated VE against severe illness was 93·3% (95% CI: 92·1-94·3) in partially- vaccinated and 98·2% (95% CI: 97·9-98·5) in fully-vaccinated and against death was 94·1% (95% CI: 92·5-95·4) in partially-vaccinated and 98·7% (95% CI: 98·3-99·0) in fully-vaccinated. VE exceeded 92·0% in all age groups. Daily cases and deaths during the study period corresponded to a VE above 90%, as predicted by models.
The Cuban Abdala protein subunit vaccine was highly effective in preventing severe illness and death from COVID-19 under real-life conditions.
Cuban Ministry of Public Health. Genetic Engineering and Biotechnology Centre.
新冠病毒疾病（COVID-19）疫苗已被证明在降低重症和死亡方面安全有效。古巴的蛋白亚单位疫苗阿卜杜拉（Abdala）在临床试验中已显示出对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的安全性、耐受性和有效性（92.3%[95%置信区间：85.7‒95.8]）。本研究旨在评估阿卜杜拉疫苗在现实世界中的疫苗效力（VE）。
这项在哈瓦那开展的回顾性队列研究分析了古巴公共卫生部数据库（2021年5月12日至8月31日），以评估预防COVID-19导致的重症和死亡的疫苗效力（主要结局）。采用考虑随时间变化的疫苗接种状态并按人口统计学因素进行调整的Cox模型来估计风险比。进行了按年龄组的亚组分析以及包括检测人群（定量逆转录聚合酶链反应[qRT-PCR]）亚组的敏感性分析。对每日病例和死亡情况进行建模时考虑了不同的疫苗效力。
该研究纳入了1355638人（平均年龄：49.5岁[标准差：18.2]；女性704932人[52.0%]；种族数据不可得）：1324人部分/全程接种疫苗，31433人未接种疫苗。部分接种疫苗者预防重症的估计疫苗效力为93.3%（95%置信区间：92.1-94.3），全程接种疫苗者为98.2%（95%置信区间：97.9-98.5）；部分接种疫苗者预防死亡的疫苗效力为94.1%（95%置信区间：92.5-95.4），全程接种疫苗者为98.7%（95%置信区间：98.3-99.0）。在所有年龄组中，疫苗效力均超过92.0%。研究期间的每日病例和死亡情况与模型预测的疫苗效力高于90%相符。
古巴的阿卜杜拉蛋白亚单位疫苗在现实生活条件下预防COVID-19导致的重症和死亡方面非常有效。
古巴公共卫生部。基因工程与生物技术中心。
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