Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Immunization Safety Office, Division of Healthcare Quality and Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Vaccine. 2023 Jun 23;41(28):4183-4189. doi: 10.1016/j.vaccine.2023.05.029. Epub 2023 May 16.
BACKGROUND: The mechanism for anaphylaxis following mRNA COVID-19 vaccination has been widely debated; understanding this serious adverse event is important for future vaccines of similar design. A mechanism proposed is type I hypersensitivity (i.e., IgE-mediated mast cell degranulation) to polyethylene glycol (PEG). Using an assay that, uniquely, had been previously assessed in patients with anaphylaxis to PEG, our objective was to compare anti-PEG IgE in serum from mRNA COVID-19 vaccine anaphylaxis case-patients and persons vaccinated without allergic reactions. Secondarily, we compared anti-PEG IgG and IgM to assess alternative mechanisms. METHODS: Selected anaphylaxis case-patients reported to U.S. Vaccine Adverse Event Reporting System December 14, 2020-March 25, 2021 were invited to provide a serum sample. mRNA COVID-19 vaccine study participants with residual serum and no allergic reaction post-vaccination ("controls") were frequency matched to cases 3:1 on vaccine and dose number, sex and 10-year age category. Anti-PEG IgE was measured using a dual cytometric bead assay (DCBA). Anti-PEG IgG and IgM were measured using two different assays: DCBA and a PEGylated-polystyrene bead assay. Laboratorians were blinded to case/control status. RESULTS: All 20 case-patients were women; 17 had anaphylaxis after dose 1, 3 after dose 2. Thirteen (65 %) were hospitalized and 7 (35 %) were intubated. Time from vaccination to serum collection was longer for case-patients vs controls (post-dose 1: median 105 vs 21 days). Among Moderna recipients, anti-PEG IgE was detected in 1 of 10 (10 %) case-patients vs 8 of 30 (27 %) controls (p = 0.40); among Pfizer-BioNTech recipients, it was detected in 0 of 10 case-patients (0 %) vs 1 of 30 (3 %) controls (p >n 0.99). Anti-PEG IgE quantitative signals followed this same pattern. Neither anti-PEG IgG nor IgM was associated with case status with both assay formats. CONCLUSION: Our results support that anti-PEG IgE is not a predominant mechanism for anaphylaxis post-mRNA COVID-19 vaccination.
背景：mRNA COVID-19 疫苗接种后发生过敏反应的机制一直存在广泛争议；了解这种严重的不良反应对于未来类似设计的疫苗非常重要。提出的一种机制是 1 型超敏反应（即 IgE 介导的肥大细胞脱颗粒）对聚乙二醇（PEG）的反应。我们使用一种独特的测定方法，该方法之前已经在对 PEG 过敏的过敏反应患者中进行了评估，目的是比较 mRNA COVID-19 疫苗过敏反应病例患者和未发生过敏反应的疫苗接种者血清中的抗 PEG IgE。其次，我们比较了抗 PEG IgG 和 IgM，以评估替代机制。
方法：邀请美国疫苗不良事件报告系统于 2020 年 12 月 14 日至 2021 年 3 月 25 日报告的选定过敏反应病例患者提供血清样本。mRNA COVID-19 疫苗研究参与者在接种疫苗后没有过敏反应（“对照者”），且剩余血清，并按疫苗和剂量数量、性别和 10 岁年龄类别与病例以 3:1 进行频率匹配。使用双荧光微球分析（DCBA）测量抗 PEG IgE。使用两种不同的测定方法测量抗 PEG IgG 和 IgM：DCBA 和 PEG 化聚苯乙烯珠测定法。实验室人员对病例/对照状态进行了盲法评估。
结果：所有 20 例病例患者均为女性；17 例在第 1 剂后发生过敏反应，3 例在第 2 剂后发生过敏反应。13 例（65%）住院，7 例（35%）插管。与对照组相比，病例患者从接种疫苗到采集血清的时间更长（第 1 剂后：中位数为 105 天 vs. 21 天）。在 Moderna 疫苗接种者中，抗 PEG IgE 在 10 例病例患者中检出 1 例（10%），在 30 例对照组中检出 8 例（27%）（p=0.40）；在 Pfizer-BioNTech 疫苗接种者中，10 例病例患者中未检出抗 PEG IgE（0%），30 例对照组中检出 1 例（3%）（p＞n＞0.99）。抗 PEG IgE 的定量信号也呈现相同的模式。两种检测方法均未发现抗 PEG IgG 或 IgM 与病例状态有关。
结论：我们的结果支持抗 PEG IgE 不是 mRNA COVID-19 疫苗接种后过敏反应的主要机制。
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