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The recombinant feline herpesvirus 1 expressing feline Calicivirus VP1 protein is safe and effective in cats. 表达猫钙病毒 VP1 蛋白的重组猫疱疹病毒 1 对猫安全有效。
Pub Date : 2024-10-27 DOI: 10.1016/j.vaccine.2024.126468
Aoxing Tang, Meng Zhu, Jie Zhu, Da Zhang, Shiqiang Zhu, Chunchun Meng, Chuanfeng Li, Guangqing Liu

Feline herpesvirus type 1 (FHV) and feline calicivirus (FCV) are significant pathogens causing upper respiratory tract disease in cats. Existing inactivated or modified live vaccines against FCV and FHV face limitations in safety and efficacy. To overcome these challenges, a recombinant strain FHV ΔgI/gE-FCV VP1 was developed by deleting the gI/gE gene and concurrently expressing FCV VP1, using the FHV WX19 strain as the parental virus. Results indicated the presence of FCV VP1 in FHV ΔgI/gE-FCV VP1-infected CRFK cells, confirmed through protein blotting and immunofluorescence assays and virus-like particles (VLPs) of FCV were observed using transmission electron microscopy. For efficacy in cats, each animal received intranasal vaccination with 1 mL of FHV ΔgI/gE-FCV VP1 at 106 TCID50. Following completion of vaccination on day 28, animals were exposed to a potent FCV strain. Assessments included clinical signs, nasal shedding, virus neutralizing antibodies, cytokine expression and postmortem histological testing. All vaccinations with FHV ΔgI/gE-FCV VP1 were deemed safe, with significantly reduced clinical disease scores, pathological changes and viral nasal shedding following infection and robust immune responses were induced. These findings collectively suggest the effectiveness of FHV-based recombinant vaccines in preventing FCV infections.

猫疱疹病毒 1 型 (FHV) 和猫钙病毒 (FCV) 是导致猫上呼吸道疾病的重要病原体。现有的针对 FCV 和 FHV 的灭活或改良活疫苗在安全性和有效性方面存在局限性。为了克服这些挑战,我们以 FHV WX19 株为亲本病毒,通过删除 gI/gE 基因并同时表达 FCV VP1,培育出了 FHV ΔgI/gE-FCV VP1 重组株。结果表明,经蛋白质印迹和免疫荧光检测证实,在FHV ΔgI/gE-FCV VP1感染的CRFK细胞中存在FCV VP1,并利用透射电子显微镜观察到FCV的病毒样颗粒(VLPs)。为了提高猫的疗效,每只动物鼻内接种 1 mL FHV ΔgI/gE-FCV VP1,剂量为 106 TCID50。在第 28 天完成疫苗接种后,让动物接触强效 FCV 株。评估包括临床症状、鼻腔脱落、病毒中和抗体、细胞因子表达和死后组织学检测。所有接种 FHV ΔgI/gE-FCV VP1 疫苗的动物都被认为是安全的,感染后的临床疾病评分、病理变化和病毒鼻腔脱落都明显减少,并且诱导了强有力的免疫反应。这些发现共同表明,基于FHV的重组疫苗在预防FCV感染方面是有效的。
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引用次数: 0
Vaccine for hand, foot, and mouth disease (HFMD): A call to action. 手足口病(HFMD)疫苗:行动呼吁。
Pub Date : 2024-10-27 DOI: 10.1016/j.vaccine.2024.126491
Pham Hong Gam, Nguyen Minh Dung, Jeza Muhamad Abdul Aziz, Abdelrahman M Makram, Randa Elsheikh, Nguyen Tien Huy
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引用次数: 0
Documenting human papillomavirus vaccine refusal among adolescents in electronic health records: A mixed methods study. 在电子健康记录中记录青少年拒绝接种人类乳头瘤病毒疫苗的情况:一项混合方法研究。
Pub Date : 2024-10-27 DOI: 10.1016/j.vaccine.2024.126467
Nadja A Vielot, Christine A P Ballard, Denise T St Jean, Sophie Page, Kelli Hammond, Peyton Thompson, Anne M Butler, Leah M Ranney

Background: Human papillomavirus (HPV) vaccination is often refused by patients or caregivers. We conducted a mixed-methods study to understand how health care providers document HPV vaccination refusal and use this information in subsequent encounters.

Methods: Using electronic health records (EHR) in a public academic health system, we identified patients aged 9-17 years with documentation of refusal of a recommended vaccination in billing codes or clinic notes from October 15, 2015 and December 31, 2021. We summarized the number of encounters in which vaccination was refused; the incidence of HPV vaccination following an initial refusal; and the content of clinic notes describing HPV vaccination refusal. Next, we held focus groups with clinic personnel to understand strategies for documenting HPV vaccination refusal and holding future conversations about HPV vaccination.

Results: Of 523 patients with a documented vaccination refusal, 351 (67 %) refused HPV. Of these, 88 (27 %) eventually received HPV vaccination; incidence of vaccination was not associated with the method used to document refusal in the EHR (ICD-10 code versus clinic note). From focus group discussions, we learned that providers usually make brief notes describing when HPV vaccination was offered and refused, and generally plan to recommend vaccination again at a subsequent encounter. Documenting specific reasons for refusal (e.g., patient age, a conflicting priority) was considered helpful to guide future conversations.

Conclusions: Patients who refuse HPV vaccination might accept vaccination in the future if providers continue to recommend it. Documenting the refusal in EHR can provide meaningful context to guide subsequent recommendations.

背景:人乳头瘤病毒 (HPV) 疫苗接种经常遭到患者或护理人员的拒绝。我们开展了一项混合方法研究,以了解医疗服务提供者如何记录 HPV 疫苗接种拒绝并在后续接种中使用这些信息:我们使用公共学术卫生系统的电子健康记录(EHR),确定了从 2015 年 10 月 15 日到 2021 年 12 月 31 日期间在账单代码或门诊笔记中记录拒绝接受推荐疫苗接种的 9-17 岁患者。我们总结了拒绝接种疫苗的就诊次数、首次拒绝接种后接种 HPV 疫苗的发生率以及诊所记录中描述拒绝接种 HPV 疫苗的内容。接下来,我们与诊所人员进行了焦点小组讨论,以了解记录拒绝接种 HPV 疫苗的策略以及今后就 HPV 疫苗接种进行对话的策略:在 523 名有拒绝接种记录的患者中,有 351 人(67%)拒绝接种 HPV。其中,88 人(27%)最终接受了 HPV 疫苗接种;疫苗接种率与 EHR 中记录拒绝接种的方法(ICD-10 代码与门诊单)无关。从焦点小组的讨论中,我们了解到医疗服务提供者通常会做简要记录,描述何时提供和拒绝接受 HPV 疫苗接种,并通常计划在随后的就诊中再次建议接种疫苗。记录具体的拒绝原因(如患者年龄、优先事项冲突)被认为有助于指导今后的对话:结论:如果医疗服务提供者继续推荐接种,拒绝接种 HPV 疫苗的患者将来可能会接受接种。在电子病历中记录拒绝接种的情况可提供有意义的背景信息,为后续建议提供指导。
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引用次数: 0
Exploring risk factors for Raynaud's phenomenon post COVID-19 vaccination. 探索接种 COVID-19 疫苗后出现雷诺现象的风险因素。
Pub Date : 2024-10-27 DOI: 10.1016/j.vaccine.2024.126470
Tzu-Chuan Ho, Shih-Chang Chuang, Kuo-Chen Hung, Chin-Chuan Chang, Kuo-Pin Chuang, Cheng-Hui Yuan, Ming-Hui Yang, Yu-Chang Tyan

Background: Raynaud's phenomenon (RP) has recently been observed in recipients of the COVID-19 vaccine. It is unclear whether RP is directly caused by the COVID-19 vaccine. This study aims to investigate the potential causation between RP and COVID-19 vaccination.

Methods: In this study, we searched PubMed, EMBASE, and Web of Science from January 1, 2020, to March 19, 2024. We included the articles with clinical related findings, specifically case reports and case series. Conference abstracts, editorial publications, preprint, and those not specifically related to COVID-19 vaccination are excluded. The refined selection process aimed to ensure a focused and clinically relevant analysis of the association between RP and COVID-19 vaccination.

Results: A total of six articles were ultimately included in this study, comprising five case reports and one case series involving 24 patients with RP after vaccination. Baseline characteristics of the studies showed the RP post COVID-19 vaccination frequently occurred with females compared to males (70.83 vs. 29.17 %). Of the patients with RP post COVID-19 vaccination, 87.5 % (21/24) had either a history or possible predisposing factors of RP. Among the patients with detailed information of vaccination (n = 20), the number of vaccine doses was not related to RP development (45 % (1st) vs. 30 % (2nd) vs. 25 % 3rd dose). For types of vaccine, 75 % of RP were found to have received the administration of mRNA vaccine (15/20).

Conclusion: The risk of bias was increased due to the uncontrolled study designs and small sample size, making it impossible to attribute causation between RP and COVID-19 vaccination. These few cases may have occurred independently of vaccination. However, physicians should still remain vigilant for RP following COVID-19 vaccination, particularly as the number of vaccinated individuals continues to rise.

背景:最近在 COVID-19 疫苗接种者中发现了雷诺现象(RP)。目前尚不清楚雷诺现象是否由 COVID-19 疫苗直接引起。本研究旨在调查 RP 与接种 COVID-19 疫苗之间的潜在因果关系:在本研究中,我们检索了 2020 年 1 月 1 日至 2024 年 3 月 19 日期间的 PubMed、EMBASE 和 Web of Science。我们收录了与临床研究结果相关的文章,特别是病例报告和系列病例。会议摘要、编辑出版物、预印本以及与 COVID-19 疫苗接种无关的文章均被排除在外。精选过程旨在确保对RP与COVID-19疫苗接种之间的关联进行有针对性的临床相关分析:本研究最终共纳入了六篇文章,包括五篇病例报告和一篇系列病例,涉及 24 名接种疫苗后出现 RP 的患者。研究的基线特征显示,接种 COVID-19 疫苗后出现 RP 的女性多于男性(70.83% 对 29.17%)。在接种 COVID-19 疫苗后出现 RP 的患者中,87.5%(21/24)有 RP 病史或可能的易感因素。在有详细疫苗接种信息的患者(20 人)中,疫苗接种次数与 RP 的发生无关(45%(第 1 剂) vs. 30%(第 2 剂) vs. 25%(第 3 剂))。就疫苗类型而言,75%的RP患者接种了mRNA疫苗(15/20):结论:由于研究设计不受控制且样本量较小,偏倚风险增加,因此无法确定RP与COVID-19疫苗接种之间的因果关系。这些少数病例的发生可能与疫苗接种无关。不过,医生仍应警惕接种 COVID-19 疫苗后的 RP,尤其是随着接种人数的不断增加。
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引用次数: 0
Comparable and sustained levels of S1-RBD-IgG and S1-RBD-IgA in BNT162b2 homologous and CoronaVac-BNT162b2 heterologous booster vaccination: A 22-month prospective study in Malaysia. BNT162b2同源和CoronaVac-BNT162b2异源加强免疫中S1-RBD-IgG和S1-RBD-IgA水平的可比性和持续性:在马来西亚进行的一项为期 22 个月的前瞻性研究。
Pub Date : 2024-10-26 DOI: 10.1016/j.vaccine.2024.126471
Anis Atifah Mohd Hisham, Aini Syahida Mat Yassim, Rapeah Suppian, Maryam Azlan, Amiratul Aifa Mohamad Asri, Nur Suhaila Idris, Rosediani Muhamad, Mohd Nor Norazmi

This prospective cohort study examines the long-term humoral immune responses post-COVID-19 vaccination in 146 individuals who received either a homologous three-dose BNT162b2 vaccine regimen (PPP) or two primary doses of CoronaVac followed by BNT162b2 booster (SSP) in Malaysia. The study focuses on serum anti-S1-RBD-IgG, -IgA, and -IgM, using the ELISA method. The results show that BNT162b2 outperformed CoronaVac in the two dose primary vaccination series. BNT162b2 booster dose significantly raised serum anti-S1-RBD-IgG and -IgA levels, sustaining this increase from 26 to 52 weeks after administration, regardless of the vaccine regimen. This leads to equivalent levels of anti-S1-RBD-IgG and -IgA after boosting with BNT162b2 in both groups. Breakthrough infections, particularly with the emergence of the Omicron variant, did not result in increased anti-S1-RBD-IgG and -IgA levels. No significant induction of anti-S1-RBD-IgM was observed following multiple vaccine doses. The long-term investigation revealed that PPP and SSP groups had comparable humoral immune responses to SARS-CoV-2, highlighting the advantage of mRNA booster dose in our cohort.

这项前瞻性队列研究考察了在马来西亚接种过同种三剂 BNT162b2 疫苗(PPP)或两剂 CoronaVac 后接种 BNT162b2 加强剂(SSP)的 146 人在接种 COVID-19 疫苗后的长期体液免疫反应。研究采用 ELISA 方法,重点检测血清中的抗 S1-RBD-IgG、-IgA 和 -IgM。结果显示,BNT162b2 在两剂初级疫苗接种系列中的表现优于 CoronaVac。BNT162b2加强剂量可显著提高血清中抗S1-RBD-IgG和-IgA的水平,并且在接种后26周至52周内,无论采用哪种疫苗接种方案,血清中的抗S1-RBD-IgG和-IgA水平都会持续上升。这导致两组接种 BNT162b2 后的抗-S1-RBD-IgG 和-IgA 水平相当。突破性感染,尤其是奥米克龙变异株的出现,并没有导致抗-S1-RBD-IgG 和 -IgA水平的升高。多次接种疫苗后也没有观察到明显的抗-S1-RBD-IgM诱导。长期调查显示,PPP 组和 SSP 组对 SARS-CoV-2 的体液免疫反应不相上下,这凸显了 mRNA 强化剂量在我们队列中的优势。
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引用次数: 0
A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. 在一项三期临床研究中,基于改良安卡拉疫苗载体的多价 RSV 疫苗显示出对老年人 RSV 引起的疾病具有适度的保护作用。
Pub Date : 2024-10-25 DOI: 10.1016/j.vaccine.2024.126427
Elke Jordan, Victoria Jenkins, Günter Silbernagl, Maria Paulina Velasco Chávez, Darja Schmidt, Frauke Schnorfeil, Stephanie Schultz, Liddy Chen, Fernanda Salgado, Jeanne-Marie Jacquet, Tobias Welte, Laurence De Moerlooze

Respiratory syncytial virus (RSV) causes a significant disease burden in older adults. The live recombinant vaccine based on a nonreplicating modified vaccinia Ankara (MVA-BN) poxvirus, MVA-BN-RSV, encoding for multiple proteins of RSV subtypes A and B, was assessed for efficacy against respiratory disease caused by RSV. Adults aged ≥60 years, with or without underlying chronic conditions, were enrolled and randomized in a 1:1 ratio to receive a single dose of vaccine or placebo and were followed for disease caused by RSV infection during the 2022-2023 season. The 2 primary endpoints were RSV-associated lower respiratory tract disease (LRTD) with ≥3 and ≥ 2 symptoms; acute respiratory disease (ARD) was a key secondary endpoint. The humoral RSV-specific immune response was assessed at baseline and 14 days post-vaccination. Safety was evaluated by collection of solicited adverse events (AEs) and unsolicited AEs for 7 and 28 days post-vaccination respectively, and SAEs for the entire study period. In total, 18,348 participants were included in the final efficacy and safety analyses. Vaccine efficacy was 42.9 % (95 % CI: -16.1; 71.9) against RSV-associated LRTD with ≥3 symptoms, 59.0 % (95 % CI: 34.7; 74.3) against LRTD with ≥2 symptoms, and 48.8 % (95 % CI: 25.8; 64.7) against ARD. The primary objective was not met for LRTD with ≥3 symptoms since the lower bound of the 95 % CI was below 20 %, the prespecified success criterion. The vaccine-elicited immune response showed mean fold-increases of 1.7 for RSV A and B neutralizing antibodies and 2.9 and 4.3 for RSV-specific IgG and IgA, respectively. The vaccine displayed mild to moderate reactogenicity, and no safety concerns were identified. MVA-BN-RSV induced suboptimal protection against RSV-associated LRTD, likely due to suboptimal neutralizing antibody response. The vaccine had an acceptable safety profile and confirmed immunogenicity, overall showing promise for MVA-BN-vectored constructs targeting other diseases. Trial Registration:Clinicaltrials.gov Identifier NCT05238025 (Registered February 14, 2022).

呼吸道合胞病毒(RSV)给老年人带来了沉重的疾病负担。我们评估了基于非复制改良安卡拉疫苗(MVA-BN)痘病毒的重组活疫苗 MVA-BN-RSV(编码 RSV A 和 B 亚型的多种蛋白)对 RSV 引起的呼吸道疾病的疗效。年龄≥60岁、患有或不患有基础慢性疾病的成人被纳入研究,并按1:1的比例随机分配接受单剂量疫苗或安慰剂,并在2022-2023年期间对RSV感染引起的疾病进行随访。两个主要终点是RSV相关的下呼吸道疾病(LRTD),症状≥3和≥2;急性呼吸道疾病(ARD)是关键的次要终点。体液 RSV 特异性免疫反应在基线和接种后 14 天进行评估。安全性通过收集接种后 7 天和 28 天的主动不良事件 (AE) 和非主动不良事件以及整个研究期间的 SAE 进行评估。共有 18348 名参与者参与了最终的有效性和安全性分析。疫苗对≥3 种症状的 RSV 相关 LRTD 的有效率为 42.9% (95 % CI: -16.1; 71.9),对≥2 种症状的 LRTD 的有效率为 59.0% (95 % CI: 34.7; 74.3),对 ARD 的有效率为 48.8% (95 % CI: 25.8; 64.7)。由于 95 % CI 的下限低于 20%,即预设的成功标准,因此症状≥3 的 LRTD 未达到主要目标。疫苗诱导的免疫反应显示,RSV A 型和 B 型中和抗体的平均增加倍数分别为 1.7 倍,RSV 特异性 IgG 和 IgA 的平均增加倍数分别为 2.9 倍和 4.3 倍。疫苗的致反应性为轻度至中度,未发现安全性问题。MVA-BN-RSV 对 RSV 相关 LRTD 的保护效果不理想,这可能是由于中和抗体反应不理想造成的。该疫苗的安全性可接受,免疫原性也得到了证实,总体上显示了针对其他疾病的 MVA-BN 病毒构建物的前景。试验注册:Clinicaltrials.gov Identifier NCT05238025(2022年2月14日注册)。
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引用次数: 0
Acute autoimmune hepatitis following COVID-19 mRNA vaccination: A population-based study using electronic health records in Singapore. 接种 COVID-19 mRNA 疫苗后出现急性自身免疫性肝炎:利用新加坡电子健康记录开展的一项基于人群的研究。
Pub Date : 2024-10-24 DOI: 10.1016/j.vaccine.2024.126462
Amelia Jing Jing Ng, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Aaron Jun Yi Yap, Wan Cheng Chow, Nicholas Kai Ming Ng, Sally Bee Leng Soh

Reports of coronavirus disease 2019 (COVID-19) vaccine-induced autoimmune hepatitis (AIH) have been largely limited to case reports and case series. To further investigate the association between COVID-19 mRNA vaccination and AIH, we conducted a nationwide study using observed-over-expected (O/E) and Self-Controlled Case Series (SCCS) analyses for acute presentations of AIH (AAIH) warranting admission. Patients were included if they had one or more of the following hepatitis-related signs and symptoms (fever, lethargy, jaundice or abdominal pain) reported up to 3 months prior to admission, deranged liver function tests [alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of laboratory reference ranges], as well as biopsy results characteristic of AIH or response to steroid treatment for cases which did not undergo biopsy. Seventy-six patients fulfilled our case definition of AAIH within the study period from 1 January 2019 to 28 February 2023, with 6 patients having an estimated onset of AAIH within 42 days of COVID-19 mRNA vaccination. All 6 patients were females aged 40 years and above. In the O/E analysis, the rate ratios of AAIH among females aged 40 years and above in the primary cohort were 1.12 (95% confidence interval (CI) 0.14-9.40) and 1.06 (95% CI 0.24-4.74) in the 21 days and 42 days following vaccination respectively. In the SCCS analysis, we did not observe any statistically significant increase in incidence of AAIH in the 21 and 42 days following COVID-19 mRNA vaccination for both the primary and supplementary cohorts, as well as in the subgroup analysis involving females aged 40 years and above. Our findings suggest that COVID-19 mRNA vaccination does not appear to be associated with increased risk of AAIH requiring admissions in the population, although larger studies are required to confirm these findings.

有关2019年冠状病毒病(COVID-19)疫苗诱发自身免疫性肝炎(AIH)的报道大多局限于病例报告和病例系列。为了进一步研究 COVID-19 mRNA 疫苗接种与自身免疫性肝炎之间的关系,我们在全国范围内开展了一项研究,采用观察-超预期(O/E)和自控病例系列(SCCS)分析方法,对需要入院的急性自身免疫性肝炎(AAIH)进行分析。如果患者在入院前 3 个月内出现以下一种或多种肝炎相关症状和体征(发热、嗜睡、黄疸或腹痛),肝功能检测异常[丙氨酸转氨酶 (ALT) 或天冬氨酸转氨酶 (AST) 超过实验室参考范围上限的三倍],以及活检结果具有 AIH 特征或对类固醇治疗有反应(未进行活检的病例),则可纳入该患者。在2019年1月1日至2023年2月28日的研究期间,有76名患者符合我们对AAIH病例的定义,其中6名患者估计在接种COVID-19 mRNA疫苗后42天内发病。所有 6 名患者均为女性,年龄在 40 岁及以上。在 O/E 分析中,接种疫苗后 21 天和 42 天内 40 岁及以上女性的 AAIH 比率分别为 1.12(95% 置信区间 (CI):0.14-9.40)和 1.06(95% 置信区间 (CI):0.24-4.74)。在SCCS分析中,我们没有观察到接种COVID-19 mRNA疫苗后21天和42天内AAIH发病率有任何统计学意义上的显著增加,无论是在主要队列和补充队列中,还是在涉及40岁及以上女性的亚组分析中。我们的研究结果表明,接种 COVID-19 mRNA 疫苗似乎与需要入院治疗的 AAIH 风险增加无关,但需要更大规模的研究来证实这些结果。
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引用次数: 0
Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study. 加纳 15 岁及以上人群接种 mRNA COVID-19 疫苗的安全性:队列事件监测研究。
Pub Date : 2024-10-23 DOI: 10.1016/j.vaccine.2024.126460
Delese Mimi Darko, Seth Kwaku Seaneke, Eric Karikari-Boateng, Edwin Nkansah, Kwame Amponsa-Achiano, Naziru Tanko Mohamed, Harriet Affran Bonful, Richard Osei Buabeng, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah Ewudzie-Sampson, Alexander Mwinteru Derizie, Adjabui D Neimatu, Agongo A Wilfred, Comfort Ogar, Aida Hagos, George Tsey Sabblah
<p><strong>Introduction: </strong>The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.</p><p><strong>Methods: </strong>We conducted a prospective cohort event monitoring study in seven selected static vaccination center in six of Ghana's 16 regions. The choice of regions was based on their geographical locations and the incidence rate of COVID-19 at the time of the study. The study was conducted with people aged 15 years and older who were vaccinated with mRNA COVID-19 vaccines, including pregnant women. Study participants were recruited starting in November 2021, with the last participant followed up in August 2022. Persons vaccinated were followed up on days 1, 7, and 28 post-dose 1 and up to 91 days after dose 2. AEFIs were described with the most specific, or lowest-level, term using the Medical Dictionary for Regulatory Activities (MedDRA) version 26.1. Frequencies of AEFIs after each vaccine dose and vaccination center were determined. Cox-proportional hazard regression was used to assess the independent risk factors associated with the incidence of AEFI among the participants.</p><p><strong>Results: </strong>Overall, 4678 persons who received Pfizer-BioNTech or Moderna COVID-19 vaccines from the seven vaccination centers were enrolled in the study. The mean age of participants was 32.9 years (SD ± 14.4). A total of 17.4 % (95 % CI: 16.3 % to 18.5 %) of participants experienced AEFI, with a higher incidence among Moderna COVID-19 vaccine recipients (20.4 %) compared to Pfizer-BioNTech COVID-19 vaccine recipients (14.0 %). The top five common AEFIs included injection site pain, headache, dizziness, fatigue, and fever. No serious AEFIs were reported during the study. Factors such as vaccination center and history of chronic medical conditions influenced the risk of experiencing an AEFI. Cox-proportional hazard regression revealed a 37 % lower risk of AEFI with the Pfizer-BioNTech COVID-19 vaccine compared to the Moderna COVID-19 vaccine.</p><p><strong>Conclusion: </strong>The study on mRNA COVID-19 vaccines in Ghana showed that the vaccines are tolerated well with no significant safety concerns. Reports of systemic and local events were consistent with those reported in the summary of product characteristics of the two vaccines. The study's outcome showed that there were no safety issues with mRNA COVID-19 vaccines in Ghana.
简介:COVID-19 疫苗在大流行期间以前所未有的速度得到开发,这就要求在批准后进行非常规的安全监测,以促进对其效益-风险状况的持续评估。在加纳,食品药品管理局批准了其中六种疫苗的紧急使用许可,包括两种 mRNA COVID-19 疫苗,即辉瑞生物技术公司生产的 COVID-19 疫苗和 Moderna COVID-19 疫苗。该研究的目的是估计接种 mRNA COVID-19 疫苗的人群中免疫接种后不良事件(AEFIs)和特别关注不良事件(AESIs)的发生率,并确定与 AEFIs 发生相关的因素:我们在加纳 16 个地区中的 6 个地区选定的 7 个固定疫苗接种中心开展了一项前瞻性队列事件监测研究。选择这些地区的依据是它们的地理位置和研究时 COVID-19 的发病率。研究对象为接种过 mRNA COVID-19 疫苗的 15 岁及以上人群,包括孕妇。研究参与者从 2021 年 11 月开始招募,最后一名参与者的随访时间为 2022 年 8 月。在接种第一剂疫苗后的第 1 天、第 7 天和第 28 天,以及接种第二剂疫苗后的第 91 天,对接种者进行了随访。AEFI使用《监管活动医学词典》(MedDRA)26.1版中最具体或最低级的术语进行描述。确定每个疫苗剂量和接种中心后的 AEFI 频率。采用 Cox 比例危险回归法评估与参与者 AEFI 发生率相关的独立风险因素:共有4678人在7个疫苗接种中心接种了辉瑞生物技术公司或Moderna COVID-19疫苗。参与者的平均年龄为 32.9 岁(SD ± 14.4)。共有 17.4 %(95 % CI:16.3 % 至 18.5 %)的参与者发生过 AEFI,其中 Moderna COVID-19 疫苗接种者的发生率(20.4 %)高于辉瑞生物 COVID-19 疫苗接种者(14.0 %)。最常见的五种 AEFI 包括注射部位疼痛、头痛、头晕、疲劳和发烧。研究期间未报告严重的 AEFI。疫苗接种中心和慢性病史等因素会影响发生 AEFI 的风险。Cox比例危险回归显示,与Moderna COVID-19疫苗相比,Pfizer-BioNTech COVID-19疫苗的AEFI风险低37%:在加纳进行的 mRNA COVID-19 疫苗研究表明,疫苗的耐受性良好,没有明显的安全性问题。关于全身和局部事件的报告与两种疫苗的产品特性摘要中的报告一致。研究结果表明,mRNA COVID-19 疫苗在加纳不存在安全性问题。在各国计划将 COVID-19 疫苗常规化的过程中,这项研究的结果可作为重要的宣传工具来解决疫苗犹豫不决的问题。此外,在未来的大流行病期间,主动监测研究还可作为药物警戒系统薄弱的中低收入国家 (LMIC) 开展此类研究的范例。
{"title":"Safety of mRNA COVID-19 vaccines among persons 15- years and above in Ghana: A cohort event monitoring study.","authors":"Delese Mimi Darko, Seth Kwaku Seaneke, Eric Karikari-Boateng, Edwin Nkansah, Kwame Amponsa-Achiano, Naziru Tanko Mohamed, Harriet Affran Bonful, Richard Osei Buabeng, Adela Ashie, Abena Asamoa-Amoakohene, Jeremiah Ewudzie-Sampson, Alexander Mwinteru Derizie, Adjabui D Neimatu, Agongo A Wilfred, Comfort Ogar, Aida Hagos, George Tsey Sabblah","doi":"10.1016/j.vaccine.2024.126460","DOIUrl":"https://doi.org/10.1016/j.vaccine.2024.126460","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;The development of COVID-19 vaccines during the pandemic occurred with an unprecedented speed, requiring extraordinary post-approval safety monitoring to facilitate ongoing evaluation of their benefit-risk profile. In Ghana, the Food and Drugs Authority granted emergency use authorization to six of these vaccines including the two mRNA COVID-19 vaccines, namely, Pfizer-BioNTech and Moderna COVID-19 vaccines. The objective of the study was to estimate the incidence of adverse events following immunization (AEFIs) and adverse events of special interest (AESIs) in persons vaccinated with mRNA COVID-19 vaccines, and to identify factors associated with the development of AEFIs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a prospective cohort event monitoring study in seven selected static vaccination center in six of Ghana's 16 regions. The choice of regions was based on their geographical locations and the incidence rate of COVID-19 at the time of the study. The study was conducted with people aged 15 years and older who were vaccinated with mRNA COVID-19 vaccines, including pregnant women. Study participants were recruited starting in November 2021, with the last participant followed up in August 2022. Persons vaccinated were followed up on days 1, 7, and 28 post-dose 1 and up to 91 days after dose 2. AEFIs were described with the most specific, or lowest-level, term using the Medical Dictionary for Regulatory Activities (MedDRA) version 26.1. Frequencies of AEFIs after each vaccine dose and vaccination center were determined. Cox-proportional hazard regression was used to assess the independent risk factors associated with the incidence of AEFI among the participants.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Overall, 4678 persons who received Pfizer-BioNTech or Moderna COVID-19 vaccines from the seven vaccination centers were enrolled in the study. The mean age of participants was 32.9 years (SD ± 14.4). A total of 17.4 % (95 % CI: 16.3 % to 18.5 %) of participants experienced AEFI, with a higher incidence among Moderna COVID-19 vaccine recipients (20.4 %) compared to Pfizer-BioNTech COVID-19 vaccine recipients (14.0 %). The top five common AEFIs included injection site pain, headache, dizziness, fatigue, and fever. No serious AEFIs were reported during the study. Factors such as vaccination center and history of chronic medical conditions influenced the risk of experiencing an AEFI. Cox-proportional hazard regression revealed a 37 % lower risk of AEFI with the Pfizer-BioNTech COVID-19 vaccine compared to the Moderna COVID-19 vaccine.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;The study on mRNA COVID-19 vaccines in Ghana showed that the vaccines are tolerated well with no significant safety concerns. Reports of systemic and local events were consistent with those reported in the summary of product characteristics of the two vaccines. The study's outcome showed that there were no safety issues with mRNA COVID-19 vaccines in Ghana. ","PeriodicalId":94264,"journal":{"name":"Vaccine","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142515713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk of major adverse cerebro-cardiovascular events following BNT162b2, CoronaVac, and ChAdOx1 vaccination and SARS-CoV-2 infection: A self-controlled case-series study. 接种 BNT162b2、CoronaVac 和 ChAdOx1 疫苗以及感染 SARS-CoV-2 后发生重大脑心血管不良事件的风险:一项自我对照病例系列研究。
Pub Date : 2024-10-23 DOI: 10.1016/j.vaccine.2024.126465
Norazida Ab Rahman, Teck Long King, Kalaiarasu M Peariasamy, Sheamini Sivasampu

Objective: To assess the potential risk of major adverse cerebro-cardiovascular events (MACCE) associated with COVID-19 vaccination and SARS-CoV-2 infection.

Methods: This self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods.

Results: The risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9-12.1) (BNT162b2), 9.2 (95% CI 9.1-9.3) (CoronaVac), and 6.8 (95% CI 6.6-7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08-2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32-3.76) and with CVD (IRR 1.98; 95% CI 1.61-2.34).

Conclusions: Our findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.

目的评估与 COVID-19 疫苗接种和 SARS-CoV-2 感染相关的重大不良脑-心血管事件 (MACCE) 的潜在风险:这项自我对照病例系列研究使用了马来西亚全国健康数据库。研究对象包括 2021 年 2 月 24 日至 2022 年 6 月 30 日期间住院的年龄≥18 岁的人。研究结果是MACCE的综合结果:中风、急性缺血性心脏病和心血管死亡。暴露因素为 COVID-19 疫苗接种和 SARS-CoV-2 感染。风险期为暴露后的第 1 天至第 21 天。采用条件泊松回归模型估算了风险期和对照期结果的发病率比(IRR)和95%置信区间(CI):每 10 万剂疫苗接种后 21 天内发生 MACCE 的风险分别为 12.0(95% CI 11.9-12.1)(BNT162b2)、9.2(95% CI 9.1-9.3)(CoronaVac)和 6.8(95% CI 6.6-7.0)(ChAdOx1)。发病率比显示,对于未患心血管疾病 (CVD) 的人来说,接种第一、第二或第三剂 BNT162b2、CoronaVac 和 ChAdOx1 疫苗不会增加 MACCE 风险。对于患有心血管疾病的人来说,这一结果是一致的。无论是同源疫苗还是异源疫苗,疫苗加强剂量都不会增加 MACCE 风险。按种族群体进行的分析发现,印度人在首次接种 ChAdOx1 后发生 MACCE 的风险略有升高(IRR 为 1.64;95% CI 为 1.08-2.48)。在其他亚组分析中未观察到明显关联。在无心血管疾病(IRR为3.54;95% CI为3.32-3.76)和有心血管疾病(IRR为1.98;95% CI为1.61-2.34)的人群中,SARS-CoV-2感染与MACCE风险显著增加有关:我们的研究结果支持COVID-19疫苗良好的安全性,并表明COVID-19疫苗的总体效益风险比仍然是积极的。
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引用次数: 0
"But then that's another barrier": A qualitative study of parent and provider perspectives on rural versus urban disparities in adolescent vaccination. "但这又是一个障碍":从家长和医疗服务提供者的角度对青少年疫苗接种中的农村与城市差异进行定性研究。
Pub Date : 2024-10-21 DOI: 10.1016/j.vaccine.2024.126456
Sarah E Brewer, Jessica R Cataldi, Cathryn Perreira, Andrea Nederveld, Michael P Fisher, Anna Furniss, Charnetta Williams, Sean T O'Leary, Amanda F Dempsey

Purpose: Vaccination rates are significantly lower among adolescents living in rural areas compared to those living in urban areas. The objective of this study was to understand the factors contributing to disparities in vaccination between adolescents in rural compared to urban areas.

Methods: Semi-structured qualitative interviews were conducted with parents and providers in 16 rural and 4 urban counties of Colorado. Interview questions followed the socioecological model of health and addressed personal, interpersonal, community, and environment/structural barriers and facilitators that impact adolescent vaccination rates. Qualitative content analysis with a directed content analysis approach was used. Urban and rural interviews were compared to identify barriers unique to rural communities.

Findings: Reported barriers included lack of vaccine access at primary care, lack of routine preventive care utilization, the need to take off time from work and school, and misinformation about vaccines. Barriers that were unique to rural communities included structural barriers such as lack of evening and weekend appointments, providers not stocking vaccines, short provider tenures, and costs; logistical barriers such as the need for multiple visits to multiple locations and distance and travel time; and beliefs and behaviors such as an overreliance on sports physicals (in lieu of preventive visits) and natural lifestyle cultures.

Conclusions: There are unique challenges to adolescent vaccination in rural areas that contribute to fewer adolescents receiving their recommended vaccines. Addressing structural barriers may address this disparity.

目的:与城市青少年相比,农村青少年的疫苗接种率明显偏低。本研究的目的是了解造成农村地区与城市地区青少年疫苗接种率差异的因素:对科罗拉多州 16 个农村县和 4 个城市县的家长和医疗服务提供者进行了半结构化定性访谈。访谈问题遵循健康的社会生态模式,涉及影响青少年疫苗接种率的个人、人际、社区和环境/结构障碍和促进因素。采用定向内容分析法进行定性内容分析。对城市和农村的访谈进行了比较,以确定农村社区特有的障碍:所报告的障碍包括基层医疗机构缺乏疫苗接种渠道、缺乏常规预防性医疗服务、需要请假工作和上学以及关于疫苗的错误信息。农村社区特有的障碍包括结构性障碍,如缺乏晚间和周末预约、医疗服务提供者没有疫苗储备、医疗服务提供者任期较短以及费用;后勤障碍,如需要在多个地点多次就诊以及距离和旅行时间;以及信仰和行为,如过度依赖运动体检(代替预防性就诊)和自然生活方式文化:结论:农村地区的青少年接种疫苗面临着独特的挑战,导致接受推荐疫苗接种的青少年人数较少。解决结构性障碍可能会消除这种差异。
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引用次数: 0
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Vaccine
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