Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Centre d'Investigation Clinique, 75014 Paris, France.
Inserm, CIC 1417, F-CRIN, I-REIVAC, 75014 Paris, France.
Viruses. 2022 Sep 20;14(10):2086. doi: 10.3390/v14102086.
The efficacy of vaccines against coronavirus disease 2019 (COVID-19) has now been well established in phase III clinical trials. However, clinical studies based on real-world data remain critical to assess vaccines effectiveness (VE), especially in specific populations and against variants of concern (VOC). This review presents the principles and methods of VE studies and the main available results on VE of COVID-19 vaccines at the time of Omicron circulation. References for this narrative review were identified through searches of PubMed database up to 13 September 2022. The results of phase III clinical trials have been globally confirmed by VE in real-life studies, including in the elderly. Emergence of VOC Omicron emphasized the importance of booster doses to maintain a high level of protection against severe forms. There are still numerous challenges regarding booster(s) and duration of immunity, particularly in specific subpopulations, and regarding the need for adapted vaccines.
疫苗对 2019 年冠状病毒病（COVID-19）的疗效已在 III 期临床试验中得到充分证实。然而，基于真实世界数据的临床研究对于评估疫苗的有效性（VE）仍然至关重要，特别是在特定人群和针对关注的变异株（VOC）方面。本综述介绍了 VE 研究的原理和方法，以及在奥密克戎流行时 COVID-19 疫苗 VE 的主要现有结果。本叙述性综述的参考文献通过在 PubMed 数据库中搜索至 2022 年 9 月 13 日确定。III 期临床试验的结果已被全球范围内的真实世界研究中的 VE 所证实，包括在老年人中。VOC 奥密克戎的出现强调了加强针的重要性，以保持对严重形式的高保护水平。关于加强针及其免疫持续时间，特别是在特定亚人群中，以及关于是否需要适应性疫苗，仍然存在许多挑战。
