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A tick (Ixodida) - carrier for several diseases of humans and animals, for exampel the dangerous Lyme disease, babesiosis, anaplasmosis, Powassan virus disease and many more.
蜱虫(Ixodida)——多种人类和动物疾病的载体,例如危险的莱姆病、巴贝斯虫病、无形体病、波瓦桑病毒病等众多疾病。
Fhm | Moment | Getty Images
Fhm | 瞬间 | 盖蒂图片社
Pfizer
辉瑞
on Monday said it will seek regulatory approval for a Lyme disease vaccine candidate despite the shot failing a late-stage trial.
周一表示,尽管这种疫苗在晚期试验中失败,但公司仍将继续寻求监管机构批准这种莱姆病疫苗候选产品。
Pfizer said the vaccine missed the trial's statistical goal because not enough people in the study contracted Lyme disease to be confident in the results. Still, the company said the shot reduced the rate of infection by more than 70% in people who received the vaccine versus placebo, efficacy the company thinks is strong enough to take to regulators.
辉瑞公司表示,由于研究中感染莱姆病的人数不足,疫苗未能达到试验的统计目标。然而,该公司表示,与安慰剂相比,接种疫苗的人群感染率降低了70%以上,公司认为这一有效性足以提交给监管机构。
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'The efficacy shown in the VALOR study of more than 70% is highly encouraging and creates confidence in the vaccine's potential to protect against this disease that can be debilitating,' Pfizer Chief Vaccines Officer Annaliesa Anderson said in a statement.
“VALOR 研究中显示出的超过 70% 的疗效非常令人鼓舞,并增强了我们对这种疫苗保护人们免受这种可能令人虚弱的疾病侵害的潜力的信心,”辉瑞首席疫苗官安娜莉萨·安德森在一份声明中表示。
A vaccine for Lyme disease isn't expected to become a best-seller for Pfizer, with the company's partner Valneva estimating peak annual sales of $1 billion. Pfizer expects overall revenue of around $60 billion this year, with its Covid-19 vaccine representing more than $5 billion of that forecast.
莱姆病疫苗预计不会成为辉瑞的畅销产品,其合作伙伴瓦尔内瓦估计该疫苗的年销售峰值为10亿美元。辉瑞预计今年整体收入约为600亿美元,其中新冠疫苗占预测收入的50多亿美元。
But Pfizer had billed the Lyme vaccine results as one of its major catalysts this year, and it represented a chance to introduce the only human vaccine for Lyme disease.
但是,辉瑞公司曾将莱姆病疫苗结果列为今年的主要催化剂之一,这也代表着推出唯一一款人类莱姆病疫苗的机会。
Moving forward with a shot that technically failed a clinical trial under an administration that has preached stricter scrutiny for vaccines may prove risky for Pfizer, and it could serve as a litmus test for vaccine policy in the U.S.
推进一项在严格审查疫苗的政府管理下临床试验技术上失败的疫苗可能是辉瑞公司的风险之举,而且这项举措可能会成为美国疫苗政策的试金石。
Lyme disease is an illness caused by bacteria most commonly spread to humans from ticks. It can cause arthritis, muscle weakness and pain. About half a million Americans are diagnosed with or treated for Lyme disease every year, according to
莱姆病是一种由细菌引起的疾病,最常见的是通过蜱虫传播给人类。它会导致关节炎、肌肉无力和疼痛。根据统计,每年大约有五十万美国人被诊断出患有莱姆病或接受治疗。
estimates
估计
from the Centers for Disease Control and Prevention.
来自疾病控制和预防中心。
Despite the disease's prevalence, especially in the Northeast, there isn't a vaccine for humans available. A company that would later become
尽管这种疾病很普遍,尤其是在东北部,但目前还没有可用的人类疫苗。一家后来成为
GSK
葛兰素史克
introduced a shot called LYMErix in 1998 but pulled it only a few years later after public concerns about safety tanked demand. That experience hobbled development of Lyme vaccines for humans, though multiple companies now make them for dogs.
1998年推出了一种名为LYMErix的疫苗,但在公众对安全性的担忧导致需求骤降后,仅几年后就将其撤回。这一经历阻碍了人类莱姆病疫苗的研发,尽管现在有多家公司生产用于狗的莱姆病疫苗。
Pfizer and Valneva have faced their own setbacks. In 2023, the companies
辉瑞和瓦尔内瓦也遭遇了各自的挫折。2023年,这些公司
dropped
掉落
about half of the participants in the Phase 3 trial because of quality concerns with third-party clinical trial site operator Care Access. The trial had initially enrolled about 18,000 people and after the cuts ended up with about 9,400.
由于第三方临床试验现场运营商Care Access的质量问题,约一半的参与者被从第三阶段试验中剔除。该试验最初招募了大约18,000人,削减后最终剩下约9,400人。
The companies' vaccine targets the outer surface protein A of the bacteria that cause Lyme disease. A vaccinated person creates antibodies that are passed to a tick and prevent the bacterium from being transferred from the tick to the human. The series involves three shots in the first year, then a booster dose the following year.
这些公司的疫苗针对导致莱姆病的细菌的表面蛋白A。接种疫苗的人会产生抗体,这些抗体会传递给蜱虫,从而防止细菌从蜱虫转移到人体。该疫苗系列在第一年需要注射三针,然后在第二年再注射一剂加强针。
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The companies said they didn't observe any safety concerns in the trial.
这些公司表示,他们在试验中没有观察到任何安全问题。
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