辉瑞/BioNTech COVID-19 疫苗副作用研究:关注 IgG 抗体和血清生物标志物。

IF 1.5 4区 医学 Q4 IMMUNOLOGY Central European Journal of Immunology Pub Date : 2024-01-01 Epub Date: 2024-04-09 DOI:10.5114/ceji.2024.136382
Kameran M Ali, Ayad M Ali, Peshnyar M Atta, Kochar I Mahmood, Hassan M Rostam
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引用次数: 0

摘要

导言迅速蔓延的 SARS-CoV-2 大流行病现已成为一个重大的全球公共卫生问题。目前正在分发疫苗,以限制病毒传播和死亡率。本研究的目的是监测疫苗的安全性和有效性,以确定疫苗的总体效果,并找出任何潜在的安全问题:2022 年 3 月至 2022 年 9 月期间进行了一项回顾性横断面研究,采用了经过验证的 13 项结构式问卷,分为两个部分。根据参与者的年龄和性别,按症状严重程度报告了不同的疫苗接种后副作用(SE)。此外,还对参与者接种疫苗后的一些相关血清学检测进行了调查:共有 502 名参与者(男性:262 人,女性:240 人)患有合并症(健康者:258 人,病态者:244 人),他们接种了两剂辉瑞/BioNTech mRNA 疫苗。重要的是,第二剂(D2)疫苗接种的SE明显高于单剂(D1)疫苗接种(p < 0.0001)。在 D1 接种中,注射部位疼痛(ISP)(45%)是最常见的疫苗 SE,其次是相同比例的头痛和发烧(40%),而在 D2 接种中,ISP(66%)和恶心(57%)是最常见的疫苗 SE。总之,97%(p < 0.0001)的参与者在接种 D2 疫苗时 IgG 抗体呈阳性。同样,血清 CR 蛋白水平也显著升高(p < 0.0001),与 D1 和 D2 接种时 SE 的严重程度相对应。不同性别和年龄组在接种 D1 和 D2 疫苗时的 IgG 浓度存在显著差异(p < 0.0001):从本研究的大量数据来看,mRNA 疫苗,尤其是辉瑞/BioNTech 疫苗,在减轻 SARS-CoV-2 大流行的影响方面被证明是非常安全和有效的。
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A study on the side effects caused by the Pfizer/BioNTech COVID-19 vaccine: Focus on IgG antibodies and serological biomarkers.

Introduction: The SARS-CoV-2 pandemic that spread swiftly is now a major global public health issue. Vaccines are currently being distributed in an effort to limit the viral transmission and mortality. The aim of the study was monitoring of both safety and efficacy in determining the overall effectiveness of the vaccine and identifying any potential safety concerns.

Material and methods: A retrospective, cross-sectional study employing a validated 13-item structured questionnaire divided into two sections was performed between March 2022 and September 2022. Different post-vaccination side effects (SE) according to symptoms severity in terms of age and sex for participants were reported. Additionally, some pertinent serological assays for participants' post-vaccinations were investigated.

Results: A total of 502 participants (male: 262, female: 240) with comorbidity (healthy: 258, morbid: 244) who received two Pfizer/BioNTech mRNA vaccine doses were included. Importantly, second dose (D2) vaccination was associated with significantly more SE than single dose (D1) vaccination (p < 0.0001). In D1 vaccination injection site pain (ISP) (45%), followed by equal proportions of headache and fever (40%) were the most common vaccine SE, while in D2 vaccination, ISP (66%) and nausea (57%) were reported. In all, 97% (p < 0.0001) of participants were IgG antibody positive at D2 vaccination. Similarly, serum CR protein level was elevated significantly (p < 0.0001) corresponding to the severity of SE between D1 and D2. Significant differences in IgG concentration were found between D1 and D2 vaccination in different gender and age groups (p < 0.0001).

Conclusions: In light of the extensive data from this study, it is evident that mRNA vaccines, particularly the Pfizer/BioNTech vaccine, have proven to be highly safe and effective in mitigating the impact of the SARS-CoV-2 pandemic.

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来源期刊
CiteScore
3.00
自引率
0.00%
发文量
17
审稿时长
6-12 weeks
期刊介绍: Central European Journal of Immunology is a English-language quarterly aimed mainly at immunologists.
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