de Lusignan Simon, Tsang Ruby S M, Amirthalingam Gayatri, Akinyemi Oluwafunmi, Sherlock Julian, Tripathy Manasa, Deeks Alexandra, Ferreira Filipa, Howsam Gary, Hobbs F D Richard, Joy Mark
Nuffield Department of Primary Care Health Sciences, University of Oxford, Woodstock Road, Oxford OX2 6GG, United Kingdom.
Royal College of General Practitioners Research and Surveillance Centre, 30 Euston Square, London NW1 2FB, United Kingdom.
Lancet Reg Health Eur. 2021 Jan 13;2:100029. doi: 10.1016/j.lanepe.2021.100029. eCollection 2021 Mar.
The cell-based quadrivalent influenza vaccine (QIVc) is now offered as an alternative to egg-based quadrivalent (QIVe) and adjuvanted trivalent (aTIV) influenza vaccines in the UK. While post-licensure studies show non-inferiority of cell-based vaccines, it is not known how its safety profile compares to other types of vaccines in real-world use.
We conducted a retrospective cohort study using computerised medical records from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network database. We used a self-controlled case series design and calculated the relative incidence (RI) of adverse events of interest (AEIs) over different risk periods. We then compared the RIs of AEIs within seven days of vaccination overall and between QIVc and QIVe in the 18-64 years age group, and between QIVc and aTIV in the ≥65 years age group.
The majority of AEIs occurred within seven days of vaccination, and a seasonal effect was observed. Using QIVc as the reference group, QIVe showed similar incidence of AEIs whereas live attenuated influenza vaccine (LAIV) and aTIV had lower incidence of AEIs. In the stratified analyses, QIVe and aTIV were associated with a 16% lower incidence of AEIs in the seven days post-vaccination in both the 18-64 years and ≥65 years age groups.
Routine sentinel network data allow comparisons of safety profiles of equally suitable seasonal influenza vaccines. The higher incidence of AEIs associated with QIVc suggest monitoring of several seasons would allow robust comparisons to be made.
Public Health England.
在英国，基于细胞培养的四价流感疫苗（QIVc）现作为基于鸡蛋培养的四价流感疫苗（QIVe）和佐剂三价流感疫苗（aTIV）的替代疫苗提供。虽然上市后研究表明基于细胞培养的疫苗非劣效，但在实际使用中其安全性与其他类型疫苗相比如何尚不清楚。
我们使用皇家全科医师学院（RCGP）研究与监测中心（RSC）哨点网络数据库中的计算机化医疗记录进行了一项回顾性队列研究。我们采用自我对照病例系列设计，并计算了不同风险期内感兴趣的不良事件（AEIs）的相对发病率（RI）。然后我们比较了总体接种疫苗后七天内AEIs的RI，以及18 - 64岁年龄组中QIVc和QIVe之间，以及≥65岁年龄组中QIVc和aTIV之间的RI。
大多数AEIs发生在接种疫苗后七天内，并且观察到了季节性效应。以QIVc作为参照组，QIVe显示出相似的AEIs发病率，而减毒活流感疫苗（LAIV）和aTIV的AEIs发病率较低。在分层分析中，在18 - 64岁和≥65岁年龄组中，QIVe和aTIV在接种疫苗后七天内AEIs的发病率均低16%。
常规哨点网络数据允许对同样适用的季节性流感疫苗的安全性进行比较。与QIVc相关的较高AEIs发病率表明，监测几个季节将有助于进行有力的比较。
英国公共卫生部。
