Immunisation Clinic, Medical Outpatient Clinic, University Hospital Basel, Switzerland.
SmartVax, Illawarra Medical Centre, Ballajura, Australia.
Swiss Med Wkly. 2021 Dec 14;151:w30090. doi: 10.4414/smw.2021.w30090. eCollection 2021 Dec 6.
Post-licensure surveillance of adverse events following immunisation (AEFI) is critical for detecting rare but severe AEFI. SmartVax software, using smartphone technology, actively solicits reports of AEFI via automated, opt-out SMS surveys to vaccine recipients in the days following immunisation. We report on a pilot study to test the feasibility and acceptance of SmartVax in Switzerland.
Between February and September 2020, consecutive subjects immunised at an adult immunisation clinic and the employee health service at the University Hospital of Basel were screened. Participants included three subgroups: healthcare workers (HCW), subjects with immune-mediated inflammatory diseases (IMID) and clients of the regular adult immunisation clinic. Three days after vaccination, participants received an SMS inquiring if they had any AEFI. In the case of an AEFI, subjects received an automated SMS with a link to an online survey assessing the type and temporal evolution of the AEFI. Descriptive statistics of response rate, time-to-response, frequency and type of AEFI by vaccine and clinical subgroup were performed.
Of 293 subjects screened, 276 were included (46.6% routine vaccination check-up visits, 33.3% HCW, 20.1% IMID patients) receiving 625 vaccinations during 360 immunisation visits. The SMS response rate was high (90.3%), with a median time-to-respond of 47 minutes (interquartile range11-205). After 29.8% of immunisation visits at least one AEFI was reported. There were no differences in frequency or type of AEFI between the three clinical subgroups. The recombinant, adjuvanted zoster vaccine Shingrix® was associated with the highest rate of local and systemic reactions.
Monitoring post-licensure vaccine safety using the active SMS-based surveillance system SmartVax is feasible in Switzerland. We observed a high acceptance in the diverse study population, including healthcare workers and IMID patients. High response rates in the elderly and reliable monitoring almost in real-time make SmartVax a promising tool for COVID-19 vaccine safety monitoring.
疫苗接种后不良事件（AEFI）的监测对于发现罕见但严重的 AEFI 至关重要。SmartVax 软件利用智能手机技术，在接种疫苗后几天内通过自动、退出式短信调查主动向疫苗接种者征集 AEFI 报告。我们报告了一项在瑞士测试 SmartVax 可行性和可接受性的试点研究。
2020 年 2 月至 9 月期间，对巴塞尔大学医院成人免疫诊所和员工健康服务的连续受种者进行了筛查。参与者包括三个亚组：医护人员（HCW）、免疫介导炎症性疾病（IMID）患者和常规成人免疫诊所的客户。接种疫苗后三天，参与者收到一条询问他们是否有任何 AEFI 的短信。如果发生 AEFI，受种者会收到一条自动短信，其中包含一个链接，可用于评估 AEFI 的类型和时间演变的在线调查。按疫苗和临床亚组对反应率、反应时间、AEFI 频率和类型进行描述性统计分析。
在 293 名筛查对象中，276 名（46.6%常规疫苗接种检查、33.3%HCW、20.1%IMID 患者）接受了 360 次免疫接种中的 625 次接种。短信的回复率很高（90.3%），中位数回复时间为 47 分钟（四分位距 11-205）。在 29.8%的免疫接种就诊中，至少报告了一种 AEFI。三个临床亚组之间 AEFI 的频率和类型没有差异。重组、佐剂带状疱疹疫苗 Shingrix®与局部和全身反应的发生率最高有关。
在瑞士，使用基于主动短信的监测系统 SmartVax 监测疫苗上市后安全性是可行的。我们观察到在包括医护人员和 IMID 患者在内的不同研究人群中，接受度很高。在老年人中具有较高的回复率和几乎实时的可靠监测，使得 SmartVax 成为 COVID-19 疫苗安全性监测的有前途的工具。
