Peck Li Fung, Poh Wang Woon, Lim Adena Theen, Soh Sally Bee Leng, Tham Mun Yee, Foo Belinda Pei Qin, Ng Amelia Jing Jing, Ng Patricia Suet Ling, Ang Pei San, Chan Cheng Leng, Toh Dorothy Su Lin, Lee Edmund Jon Deoon, Santosa Amelia, Thong Bernard Yu-Hor, Bever Hugo Van, Lee Haur Yueh, Sum Chee Fang, Dorajoo Sreemanee Raaj, Teo Desmond Chun Hwee
Vigilance and Compliance Branch, Health Products Regulation Group, Health Sciences Authority, Singapore.
Health Products Regulation Group, Health Sciences Authority, Singapore.
Singapore Med J. 2024 Sep 26. doi: 10.4103/singaporemedj.SMJ-2023-258.
Anaphylaxis was the first serious adverse event (AE) of special interest surfaced in Singapore following coronavirus disease 2019 (COVID-19) vaccination. Individuals who developed physician-diagnosed severe allergic reactions to the mRNA vaccines would be medically ineligible for mRNA vaccines and offered non-mRNA alternatives. This paper describes anaphylaxis reports received by the Health Sciences Authority (HSA) and presents a review of individuals who received heterologous COVID-19 vaccination.
Reports of anaphylaxis associated with the COVID-19 vaccines received till 31 July 2022 were reviewed and adjudicated using the Brighton Collaboration case definition criteria by an HSA-appointed expert panel. Additional review was conducted for cases with heterologous vaccination for any subsequent reactions until administration of third dose of COVID-19 vaccines.
Among 112 adjudicated anaphylaxis cases, majority occurred in females, adults and persons with allergy histories, which were consistent with global observations. Most cases (71%) occurred within 30 minutes of vaccination. The reporting incidence rates (IRs) of 0.67 and 0.55 per 100,000 administered doses for Comirnaty and Spikevax vaccines, respectively, were comparable with IRs reported overseas, whereas the IRs for non-mRNA vaccines (Sinovac-CoronaVac and Nuvaxovid) were much higher at 4.14 and 29.82 per 100,000 administered doses, respectively, likely due to selection bias. Review of the 20 cases following heterologous vaccination found varying reactions to subsequent vaccinations.
Anaphylaxis is a rare but serious AE in which outcomes can be mitigated with timely medical intervention. The case review helped to guide vaccination strategies and added to the cumulative knowledge of safety with heterologous vaccination.
过敏反应是2019冠状病毒病（COVID-19）疫苗接种后在新加坡出现的首个受到特别关注的严重不良事件。出现经医生诊断对信使核糖核酸（mRNA）疫苗有严重过敏反应的个体，在医学上不符合接种mRNA疫苗的条件，会为其提供非mRNA疫苗替代方案。本文描述了新加坡卫生科学局（HSA）收到的过敏反应报告，并对接受异源COVID-19疫苗接种的个体进行了综述。
对截至2022年7月31日收到的与COVID-19疫苗相关的过敏反应报告进行了审查，并由HSA指定的专家小组根据布莱顿协作组织的病例定义标准进行判定。对接受异源接种的病例进行了额外审查，以了解直至接种第三剂COVID-19疫苗后的任何后续反应。
在112例经判定的过敏反应病例中，大多数发生在女性、成年人和有过敏史的人群中，这与全球观察结果一致。大多数病例（71%）发生在接种后30分钟内。Comirnaty疫苗和Spikevax疫苗每10万剂接种量的报告发病率分别为0.67和0.55，与海外报告的发病率相当，而非mRNA疫苗（科兴新冠疫苗和诺瓦瓦克斯疫苗）的发病率则高得多，分别为每10万剂接种量4.14和29.82，这可能是由于选择偏倚。对20例异源接种后的病例进行审查发现，后续接种出现了不同反应。
过敏反应是一种罕见但严重的不良事件，及时的医疗干预可以减轻其后果。病例审查有助于指导疫苗接种策略，并增加了对异源接种安全性的累积认识。
