新加坡接种COVID-19疫苗后的过敏性休克。

Li Fung Peck, Wang Woon Poh, Adena Theen Lim, Sally Bee Leng Soh, Mun Yee Tham, Belinda Pei Qin Foo, Amelia Jing Jing Ng, Patricia Suet Ling Ng, Pei San Ang, Cheng Leng Chan, Dorothy Su Lin Toh, Edmund Jon Deoon Lee, Amelia Santosa, Bernard Yu-Hor Thong, Hugo Van Bever, Haur Yueh Lee, Chee Fang Sum, Sreemanee Raaj Dorajoo, Desmond Chun Hwee Teo
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摘要

导言:过敏性休克是新加坡在接种 2019 年冠状病毒病(COVID-19)疫苗后首次出现的严重不良反应(AE)。经医生诊断对 mRNA 疫苗产生严重过敏反应的人在医学上将不符合接种 mRNA 疫苗的资格,并将被提供非 mRNA 替代疫苗。本文介绍了卫生科学局(HSA)收到的过敏性休克报告,并对接种异源 COVID-19 疫苗的个人进行了回顾:截至 2022 年 7 月 31 日收到的与 COVID-19 疫苗相关的过敏性休克报告由卫生科学局任命的专家小组根据布莱顿协作组织的病例定义标准进行审查和裁定。在接种第三剂COVID-19疫苗之前,还对接种异源疫苗的病例的后续反应进行了额外审查:在112例裁定的过敏性休克病例中,大多数病例发生在女性、成人和有过敏史的人身上,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和Spikevax疫苗的报告发病率(IRs)分别为每10万接种剂量0.67例和0.55例,与国外报告的IRs相当,而非RNA疫苗(Sinovac-CoronaVac和Nuvaxovid)的IRs要高得多,分别为每10万接种剂量4.14例和29.82例,这可能是由于选择偏差造成的。对异源疫苗接种后的20例病例进行审查后发现,患者对后续疫苗接种的反应各不相同:过敏性休克是一种罕见但严重的急性呼吸道感染,及时的医疗干预可以减轻其后果。病例回顾有助于指导疫苗接种策略,并增加了异源疫苗接种安全性方面的知识积累。
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Anaphylaxis post-COVID-19 vaccinations in Singapore.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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