bnt162b2 (pfizer-biontech)

bnt162b2 (辉瑞生物技术公司)
  • 文章类型: Journal Article
    SARS-CoV-2Omicron变体及其亚谱系继续导致与COVID-19相关的儿科住院,严重疾病,全球死亡。BNT162b2和CoronaVac是智利使用的主要疫苗。与成年人相比,在儿科人群中对基于武汉-Hu-1菌株的疫苗的了解要少得多。鉴于全球需要加强疫苗接种以刺激针对SARS-CoV-2的新Omicron变体的免疫反应,我们在10至16岁接受异源疫苗接种的儿科队列中,针对Omicron变体BA.1的体液和细胞免疫反应进行了表征基于两种剂量的CoronaVac,两剂CoronaVac(2x)加一次加强剂量的BNT162b2[CoronaVac(2x)BNT162b2(1x)],两剂CoronaVac加两剂BNT162b2[CoronaVac(2x)+BNT162b2(2x)],和三个剂量的BNT162b2。我们观察到[CoronaVac(2x)+BNT162b2(2x)]疫苗接种显示出较高的抗S1和中和抗体滴度以及对Omicron变体具有特异性的CD4和CD8T细胞免疫,与用两个剂量的单独的CoronaVac免疫相比。此外,来自所有测试组,在接受三剂BNT162b2的个体中,对Omicron的免疫力最高。我们得出结论,与单独的两剂CoronaVac相比,用BNT162b2加强疫苗接种,诱导更大的保护性免疫。
    The SARS-CoV-2 Omicron variant and its sublineages continue to cause COVID-19-associated pediatric hospitalizations, severe disease, and death globally. BNT162b2 and CoronaVac are the main vaccines used in Chile. Much less is known about the Wuhan-Hu-1 strain-based vaccines in the pediatric population compared to adults. Given the worldwide need for booster vaccinations to stimulate the immune response against new Omicron variants of SARS-CoV-2, we characterized the humoral and cellular immune response against Omicron variant BA.1 in a pediatric cohort aged 10 to 16 years who received heterologous vaccination based on two doses of CoronaVac, two doses of CoronaVac (2x) plus one booster dose of BNT162b2 [CoronaVac(2x) + BNT162b2 (1x)], two doses of CoronaVac plus two booster doses of BNT162b2 [CoronaVac(2x) + BNT162b2 (2x)], and three doses of BNT162b2. We observed that the [CoronaVac(2x) + BNT162b2 (2x)] vaccination showed higher anti-S1 and neutralizing antibody titers and CD4 and CD8 T cell immunity specific to the Omicron variant compared to immunization with two doses of CoronaVac alone. Furthermore, from all groups tested, immunity against Omicron was highest in individuals who received three doses of BNT162b2. We conclude that booster vaccination with BNT162b2, compared to two doses of CoronaVac alone, induces a greater protective immunity.
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  • 文章类型: Case Reports
    在这里,我们报告了一例69岁的患者,他因皮肤出疹就诊于我们的皮肤科诊所,其特征是在右下肢红斑背景上出现了一组出血性囊泡和由出血性结皮覆盖的糜烂.病变很小,集群,并且大小可变(直径在1和10毫米之间)并且位于L4-L5皮体的水平。皮疹是在用BNT162b2辉瑞BioNTech疫苗完成COVID-19疫苗接种计划后三到五天开始的,并伴有流感样综合征。组织病理学检查确定了在细胞病变带状疱疹现象的背景下可能诊断为白细胞碎裂性血管炎。带状疱疹喷发的非典型方面需要额外的实验室检查,以确定免疫抑制的可能原因,即,筛查是否存在人类免疫缺陷病毒(HIV)感染,实体癌,以及血清免疫球蛋白浓度的测量,这表明受试者是艾滋病毒阳性。开始抗病毒治疗,随着病变的有利发展,患者被转诊至感染性疾病诊所开始接受抗逆转录病毒治疗(ART).
    Herein, we report the case of a 69-year-old patient who presented to our dermatology clinic for a skin eruption characterized by grouped hemorrhagic vesicles and erosions covered by hemorrhagic crusts on an erythematous background located on the lower right limb. The lesions were small, clustered, and variable in size (diameters between one and 10 mm) and located at the level of the L4-L5 dermatomes. The rash had started three to five days after the complete COVID-19 vaccination scheme with the BNT162b2 Pfizer BioNTech vaccine and had been accompanied by a flu-like syndrome. The histopathological examination established the diagnosis of leukocytoclastic vasculitis potentially in the context of a cytopathic zoster phenomenon. The atypical aspect of the zosterian eruption required additional laboratory work-up to identify possible causes of immunosuppression, i.e., screening for the presence of the human immunodeficiency virus (HIV) infection, solid cancers, as well as measurement of serum immunoglobulin concentrations, which revealed that the subject was HIV-positive. Antiviral treatment was started, with a favorable evolution of the lesions, and the patient was referred to an infectious diseases clinic for initiation of antiretroviral therapy (ART).
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  • 文章类型: Journal Article
    严重急性呼吸道综合症病毒2(SARS-CoV-2)已在全球范围内造成超过一百万人死亡,智利有超过61,000人死亡。智利政府已实施了针对SARS-CoV-2的疫苗接种计划,超过1770万人接受了完整的疫苗接种计划。最终目标是1800万人。智利最常用的疫苗是CoronaVac(Sinovac)和BNT162b2(辉瑞生物技术)。鉴于全球需要疫苗助推器来对抗新出现的病毒变种的影响,研究SARS-CoV-2的免疫反应至关重要。在这项研究中,我们描述了来自智利的接种志愿者的体液免疫反应,这些志愿者接受了由两剂CoronaVac[CoronaVac(2x)]组成的疫苗接种方案,两剂CoronaVac加一剂BNT162b2[CoronaVac(2x)+BNT162b2(1x)],和三个剂量的BNT162b2[BNT162b2(3x)]。
    我们招募了469名参与者,他们来自圣地亚哥的ClínicaDávila和康塞普西翁市的维克托·曼努埃尔·费尔南德斯健康中心,智利。此外,我们纳入了从COVID-19中恢复但未接种疫苗(RCN)的参与者.我们分析了抗体,包括反N,抗S1-RBD,和抗SARS-CoV-2的中和抗体。
    我们发现,与CoronaVac(2x)BNT162b2(1x)或BNT162b2(3x)组相比,CoronaVac(2x)和RCN组中针对SARS-CoV-2核蛋白的抗体明显更高。然而,CoronaVac(2x)+BNT162b2(1x)和BNT162b2(3x)组的S1-RBD抗体浓度高于CoronaVac(2x)组和RCN组。CoronaVac(2x)+BNT162b2(1x)和BNT162b2(3x)组之间的S1-RBD抗体滴度没有显著差异。最后,与RCN组相比,用BNT162b2(3x)免疫的组具有更高的中和抗体水平,以及CoronaVac(2x)和CoronaVac(2x)+BNT162b2(1x)组。
    这些发现表明疫苗接种诱导抗SARS-CoV-2抗体的分泌,并且BNT162b2的加强剂量对于产生保护性免疫应答是必要的。在目前的大流行状态下,这些数据支持智利政府卫生部促进异源疫苗接种的决定,因为它们表明智利人口中有很大一部分具有抗SARS-CoV-2的中和抗体。
    Severe acute respiratory syndrome virus 2 (SARS-CoV-2) has caused over million deaths worldwide, with more than 61,000 deaths in Chile. The Chilean government has implemented a vaccination program against SARS-CoV-2, with over 17.7 million people receiving a complete vaccination scheme. The final target is 18 million individuals. The most common vaccines used in Chile are CoronaVac (Sinovac) and BNT162b2 (Pfizer-Biotech). Given the global need for vaccine boosters to combat the impact of emerging virus variants, studying the immune response to SARS-CoV-2 is crucial. In this study, we characterize the humoral immune response in inoculated volunteers from Chile who received vaccination schemes consisting of two doses of CoronaVac [CoronaVac (2x)], two doses of CoronaVac plus one dose of BNT162b2 [CoronaVac (2x) + BNT162b2 (1x)], and three doses of BNT162b2 [BNT162b2 (3x)].
    We recruited 469 participants from Clínica Dávila in Santiago and the Health Center Víctor Manuel Fernández in the city of Concepción, Chile. Additionally, we included participants who had recovered from COVID-19 but were not vaccinated (RCN). We analyzed antibodies, including anti-N, anti-S1-RBD, and neutralizing antibodies against SARS-CoV-2.
    We found that antibodies against the SARS-CoV-2 nucleoprotein were significantly higher in the CoronaVac (2x) and RCN groups compared to the CoronaVac (2x) + BNT162b2 (1x) or BNT162b2 (3x) groups. However, the CoronaVac (2x) + BNT162b2 (1x) and BNT162b2 (3x) groups exhibited a higher concentration of S1-RBD antibodies than the CoronaVac (2x) group and RCN group. There were no significant differences in S1-RBD antibody titers between the CoronaVac (2x) + BNT162b2 (1x) and BNT162b2 (3x) groups. Finally, the group immunized with BNT162b2 (3x) had higher levels of neutralizing antibodies compared to the RCN group, as well as the CoronaVac (2x) and CoronaVac (2x) + BNT162b2 (1x) groups.
    These findings suggest that vaccination induces the secretion of antibodies against SARS-CoV-2, and a booster dose of BNT162b2 is necessary to generate a protective immune response. In the current state of the pandemic, these data support the Ministry of Health of the Government of Chile\'s decision to promote heterologous vaccination as they indicate that a significant portion of the Chilean population has neutralizing antibodies against SARS-CoV-2.
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  • 文章类型: Observational Study
    这项回顾性观察性研究旨在确定BNT162b2(辉瑞-BioNTech)和CoronaVac(Sinovac)疫苗对COVID-19诊断患者的症状性或严重疾病的疗效。次要目的是确定接种疫苗和未接种疫苗的患者在年龄方面的差异,合并症和病程,并确定存活率。在1463名PCR阳性患者中,55.3%接种了疫苗,44.7%未接种疫苗。虽然959名患者有轻度-中度症状,504名患者有严重的危重症状,并在重症监护病房接受治疗。患者组之间的疫苗类型和剂量分布存在统计学上的显着差异(p=0.021)。轻度-中度患者组接受2剂Biontech的比率为18.9%,但重度患者组较低(12.6%)。在轻度-中度患者组中,两剂Sinovac和两剂Biontech疫苗(四剂疫苗)的比率为5%,在重度患者组中为1.9%。患者组之间的死亡率在统计学上有显着差异(p<0.001):重度患者组为65.3%,轻度-中度患者组为1%。多变量模型显示,未接种疫苗的患者的死亡风险比接种疫苗的患者高1.5倍(p=0.042)。除了未接种疫苗外,高龄,冠状动脉疾病(CAD),糖尿病(DM),慢性阻塞性肺疾病(COPD),慢性肾脏病(CKD),研究发现,肥胖与较高的死亡风险相关.此外,与CoronaVac组相比,接种至少2剂BNT162b2(Pfizer-BioNTech)疫苗的个体死亡率降低更为明显.
    This retrospective observational study is aimed to determine the efficacy of BNT162b2 (Pfizer-BioNTech) and CoronaVac (Sinovac) vaccines against symptomatic or severe disease in COVID-19-diagnosed patients. The secondary aim was to define the differences between vaccinated and un-vaccinated patients in terms of age, comorbidities and course of the disease, and to determine the survival rates. Of the 1463 PCR-positive patients, 55.3 % were vaccinated, and 44.7 % were unvaccinated. While 959 patients had mild-moderate symptoms, 504 patients had severe-critical symptoms and were treated in the intensive care unit. There was a statistically significant difference in the distribution of the type and doses of vaccines between the patient groups (p = 0.021). The rate of receiving 2 doses of Biontech was 18.9 % in the mild-moderate patient group but lower in the severe patient group (12.6 %). The rate of two doses of Sinovac and two doses of Biontech vaccine (four doses of vaccine) was 5 % in the mild-moderate patient group and 1.9 % in the severe patient group. The mortality rates were statistically significantly different (p < 0.001) between the patient groups: 65.3 % in the severe patient group and 1 % in the mild-moderate patient group. The multivariate model showed that the mortality risk of the unvaccinated patients was 1.5 times higher than the vaccinated ones (p = 0.042). In addition to being unvaccinated, advanced age, coronary artery disease (CAD), diabetes mellitus (DM), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), and obesity were found to be associated with higher mortality risk. Besides, the reduction in mortality rate was more evident in individuals vaccinated with at least 2 doses of the BNT162b2 (Pfizer-BioNTech) vaccine than in CoronaVac group.
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  • 文章类型: Case Reports
    2019年冠状病毒(COVID-19)大流行已经影响到全球7亿多人,造成近700万人死亡。目前开发或正在开发的疫苗是遏制大流行和减轻其影响的最有效工具。在土耳其,辉瑞-BioNTechCOVID-19疫苗(BNT162b2,也称为tozinameran)的接种已获得批准。我们报告了一名56岁的女性患者,患有原发性高血压,在接受第一剂Tozinameran后经历了颅内出血。病人接受了血肿的立即手术清除,在此过程中,对左大脑中动脉分叉部动脉瘤进行了宏观识别和夹闭。患者在术后第二天宣布死亡。这是由大脑中动脉分叉动脉瘤破裂引起的Tozinameran给药后的第二例颅内出血。在分析案件后,疫苗对血流动力学模式的潜在免疫触发作用与先前未知的脑动脉瘤破裂之间可能存在联系。然而,这些严重的并发症并不能成为避免接种疫苗的理由;需要进一步的研究.这项研究强调最近接种疫苗的潜在全身性合并症患者需要提高警惕,并分享我们对Tozinameran与颅内出血之间潜在关系的见解。
    The Coronavirus 2019 (COVID-19) pandemic has affected over 700 million people worldwide and caused nearly 7 million deaths. Vaccines currently developed or in development are the most effective tools for curbing the pandemic and mitigating its impacts. In Turkey, inoculation with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2, also known as tozinameran) has been approved. We report a 56-year-old female patient with underlying essential hypertension who experienced intracranial hemorrhage after receiving her first dose of tozinameran. The patient underwent immediate surgical evacuation of the hematoma, during which a left middle cerebral artery bifurcation aneurysm was macroscopically identified and clipped. The patient was pronounced deceased on the second postoperative day. This is the second case of intracranial hemorrhage following tozinameran administration caused by a ruptured middle cerebral artery bifurcation aneurysm. Upon analyzing the case, there might be a connection between the vaccine\'s potential immune-triggering effect on hemodynamic patterns and the rupture of the previously unknown cerebral aneurysm. However, these severe complications do not justify avoiding vaccines; further studies are needed. This study emphasizes the need for increased vigilance in patients with underlying systemic comorbidities who have recently been vaccinated and to share our insights into the potential relationship between tozinameran and intracranial hemorrhage.
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  • 文章类型: Journal Article
    BACKGROUND: Both SARS-CoV-2 mRNA-based vaccines [BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)] have shown high efficacy, with very modest side effects in limiting transmission of SARS-CoV-2 and in preventing the severe COVID-19 disease, characterized by a worrying high occupation of intensive care units (ICU), high frequency of intubation and ultimately high mortality rate. At the INT, in Naples, only the BNT162b2/Pfizer vaccine has been administered to cancer patients and healthcare professionals aged 16 and over. In the present study, the antibody response levels and their decline were monitored in an interval of 6-9 months after vaccine administration in the two different cohorts of workers of the INT - IRCCS \"Fondazione Pascale\" Cancer Center (Naples, Italy): the group of individuals previously infected with SARS-CoV-2 and vaccinated with a single dose; and that of individuals negative for previous exposure to SARS-CoV-2 vaccinated with two doses 21 days apart.
    METHODS: Specific anti-RBD (receptor-binding domain) titers against trimeric spike glycoprotein (S) of SARS-CoV-2 by Roche Elecsys Anti-SARS-CoV-2 S ECLIA immunoassay were determined in serum samples of 27 healthcare workers with a previously documented history of SARS-CoV-2 infection and 123 healthcare workers without, during antibody titers\' monitoring. Moreover, geometric mean titers (GMT) and relative fold changes (FC) were calculated.
    RESULTS: Bimodal titer decline was observed in both previously infected and uninfected SARS-CoV-2 subjects. A first rapid decline was followed by a progressive slow decline in the 6/9 month-period before the further vaccine boost. The trend was explained by 2 different mathematical models, exponential and power function, the latter revealing as predictive of antibody titer decline either in infected or in not previously infected ones. The value of the prolonged lower vaccine titer was about 1 log below in the 6/9-month interval after the single dose for previously infected individuals with SARS-CoV-2 and the two doses for those not previously infected. The titer change, after the boost dose administration, on the other hand, was ≥ 1.5 FC higher than the titers at the 6/9-month time-points in both cohorts. A similar quantitative immune titer was observed in both cohorts 8 days after the last boost dose. The subsequent immunoresponse trend remains to be verified.
    CONCLUSIONS: The results show that a very rapid first decline, from the highest antibody peak, was followed by a very slow decline which ensured immune protection lasting more than 6 months. The apparent absence of adverse effects of the rapid decline on the vaccine\'s immune protective role has been related to a large majority of low avidity antibodies induced by current vaccines. High avidity antibodies with prolonged anti-transmission efficacy show a longer half-life and are lost over a longer interval period. The cellular immunity, capable of preventing severe clinical diseases, lasts much longer. The unbalanced dual activity (cellular vs humoral) while effective in limiting ICU pressure and overall mortality, does not protect against transmission of SARS-CoV-2, resulting in high circulation of the virus among unvaccinated subjects, including the younger population, and the continuous production of variants characterized by changes in transmissibility and pathogenicity. The high mutation rate, peculiar to the RNA virus, can however lead to a dual opposite results: selection of defective and less efficient viruses up to extinction; risk of more efficiently transmitted variants as the current omicron pandemic.
    CONCLUSIONS: In conclusion the current bimodal antibody-titer decline, following BNT162b2 mRNA anti-SARS-CoV-2 vaccination, needs a further extended analysis to verify the protective borderline levels of immunity and the optimal administration schedule of vaccine boosters. Our current results can contribute to such goal, besides a direct comparison of other FDA-approved and candidate vaccines.
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  • 文章类型: Journal Article
    在2019年冠状病毒病(COVID-19)大流行激增之后,美国食品和药物管理局(FDA)批准紧急批准接种疫苗,以预防危及生命的COVID-19感染并发症.这些疫苗是BNT162b2,mRNA-1273。稍后,FDA还批准了JNJ-78436735。COVID-19疫苗接种没有重大副作用,但是在接种疫苗后,有一些相关的不良事件报告。心肌炎就是其中之一。根据我们对40例病例报告的分析,我们将介绍与COVID-19疫苗相关的心肌炎的流行病学和临床表现.根据我们的分析,我们发现大多数病例出现在90%的男性中,这些病例出现在29.13岁的年龄组(平均值,SD为14.39年)。在65%的案例中,患者使用BNT162b2疫苗;30%的病例报告使用mRNA-1273疫苗;5%的病例使用JNJ-78436735.在所有案件中,其中80%是在使用Moderna或Pfizer的第二剂疫苗后报告的。本研究分析了COVID-19疫苗相关性心肌炎的特点。我们发现了几个发现,从年龄来看,性别,疫苗接种类型,症状的表现,和诊断模式。这描绘了与COVID-19疫苗相关的心肌炎的图片,以及医生在治疗这种疾病时应该期待什么。我们的分析表明,与mRNA-1273和JNJ-78436735疫苗相比,接受BNT162b2疫苗后报告的病例更多。需要进行进一步的研究来分析这种关联的根本原因。
    After the surging rise in the Coronavirus disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA) approved emergency approval of vaccinations to prevent life-threatening complications of COVID-19 infection. These vaccines are BNT162b2, mRNA-1273. Later, the FDA also approved JNJ-78436735. COVID-19 vaccination does not have major side effects, but there are some concerning adverse events reported right after vaccination. Myocarditis is one of them. Based on our analysis of 40 case reports, we are presenting the epidemiology and clinical picture of myocarditis related to the COVID-19 vaccine. Based on our analysis, we found that the majority of cases were seen in males with 90% predominance, and these cases were seen in the age group of 29.13 years old (mean, SD of 14.39 years). In 65% of cases, patients took the BNT162b2 vaccine; 30% of cases were reported with the mRNA-1273 vaccine; and 5% of cases with JNJ-78436735. Of all the cases, 80% of them are reported after the second dose of the vaccine with either Moderna or Pfizer. The characteristics of COVID-19 vaccine-related myocarditis were analyzed in this study. We identified several findings, ranging from age, gender, type of vaccination, presentation of symptoms, and diagnosis modality. This depicts the picture of COVID-19 vaccine-related myocarditis and what physicians should expect when dealing with the disease. Our analysis showed that more cases were reported after receiving the BNT162b2 vaccine compared to mRNA-1273 and JNJ-78436735 vaccines. Further research needs to be conducted to analyze the underlying cause of this association.
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