"绝对出色": 没有人在试验中接种了 Moderna 的疫苗, 开发出了严重的 COVID - 19

‘Absolutely remarkable’: No one who got Moderna's vaccine in trial developed severe COVID-19

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科学COVID-19报告得到了普利策中心和西辛-西蒙斯基金会的支持。
生物技术公司 Moderna在今天的新闻稿中宣布了针对其候选疫苗的30,000人疗效试验的最终结果:只有11名接种了两剂疫苗的人感染了大流行性冠状病毒后出现COVID-19症状,而安慰剂组有185例症状。该公司表示,这一疗效为94.1%,远远高于许多疫苗科学家几周前的预期。
更令人印象深刻的是,Moderna 的候选人对严重疾病有 100% 的疗效。接种疫苗者中没有此类COVID-19病例,但安慰剂组为30例。该公司今天计划向美国食品和药物管理局(FDA)申请疫苗的紧急使用授权(EUA),并正在寻求欧洲药品管理局的类似绿灯。
今天公布的数据支持了该公司两个星期一前发布的中期报告,该报告只分析了95例病例,但产生了同样令人印象深刻的疗效。费城儿童医院的疫苗研究员保罗·奥菲特(Paul Offit)说:"我仍然希望看到所有的实际数据,但到目前为止,我们所看到的绝对是了不起的。
Moderna 对抗 SARS-CoV-2 的疫苗是导致 COVID-19 的病毒,它依赖于一种新技术,该技术使用信使 RNA (mRNA) 来编码一种称为尖峰的蛋白质,这种蛋白质可以螺柱病原体的表面。辉瑞和BioNTech已经开发出类似的MRNA疫苗,针对COVID-19,并在45,000人的试验中报告了出色的结果,疗效为95%。 在发现170例COVID-19病例后结束的这项研究中,只发生了10例重症病例,只有1例在接种疫苗的群体中。
Moderna 和 Pfizer/BioNTech 合作公司表示,他们的疫苗在所有不同群体、种族和性别中都有大致相同的工作程度。(超过7000名参与者年龄在65岁以下,超过5000人年龄在65岁以下,但患有疾病,使他们面临严重的COVID-19的较高风险;该研究还包括11,000多名有色人种。这种同样的成功对于试图优先使用新疫苗的机构来说至关重要,例如明天开会的疾病控制和预防中心(CDC)的一个顾问小组。该委员会的建议影响疾病预防控制中心关于疫苗优先顺序的决定,但各州会提出自己的指导方针。
Moderna从美国政府的"扭曲速度行动"获得10亿美元,以帮助开发其mRNA疫苗。(Pfizer 传递了此类开发资金,但已签署其疫苗高级采购订单,其疫苗具有"扭曲速度"。现代公司首席执行官史蒂芬·班塞尔说,所有的联邦资金都用于进行临床试验,如果没有它,进展肯定会被推迟。今年5月,投资者又捐助了13亿美元,帮助这个没有产品上市的年轻公司建立生产疫苗的设施。
辉瑞上周向欧盟提出了疫苗申请,导致FDA宣布将于12月10日召开疫苗咨询委员会会议,深入讨论这些数据。班塞尔说,FDA已经告诉该公司,它可能在12月17日再次召开会议,审查其欧盟申请。他说,该机构可以在24至72小时后发布欧盟A。
Bancel认为,由于现代疫苗对轻度和重度疾病的疗效很高,如果接种给面临SARS-CoV-2风险最大的人群,其影响最大。"把它给卫生保健工作者,给老年人,给糖尿病,超重,心脏病患者,"他说。"一个25岁的健康人?再给他一个疫苗。
班塞尔说,现代计划在发达国家每剂疫苗收费32至37美元,但世界其他地区的定价会更低。该公司正在与COVID-19疫苗全球获取(COVAX)基金进行谈判,该基金是一个非盈利组织,旨在通过购买和分销经批准的产品来减少全球疫苗不平等。他表示:"我们希望以分层价格为低收入国家提供这种疫苗。
班塞尔强调,他希望其他COVID-19疫苗也成功。"世界需要几个制造商才能成功,以阻止这种可怕的大流行,"他说。英国制药巨头阿斯利康与牛津大学合作,报告了其COVID-19疫苗疗效的初步证据,俄罗斯Gamaleya流行病学和微生物研究所也报告了初步证据。
Moderna希望到年底向美国政府提供2000万剂,辉瑞公司表示,它应该有5000万剂,用于在美国和达成高级采购协议的其他国家之间进行分拆。

Science’s COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
Continuing the spate of stunning news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago.
More impressive still, Moderna’s candidate had 100% efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group. The company today plans to file a request for emergency use authorization (EUA) for its vaccine with the U.S. Food and Drug Administration (FDA), and is also seeking a similar green light from the European Medicines Agency.
The data released today bolster an interim report from the company two Mondays ago that only analyzed 95 total cases but produced similarly impressive efficacy. “I would still like to see all of the actual data, but what we’ve seen so far is absolutely remarkable,” says Paul Offit, a vaccine researcher at the Children’s Hospital of Philadelphia who is a member of an independent committee of vaccine experts that advises FDA.
Moderna’s vaccine against SARS-CoV-2, the virus that causes COVID-19, relies on a novel technology that uses messenger RNA (mRNA) to code for a protein called spike that studs the surface of the pathogen. Pfizer and BioNTech have developed a similar mRNA vaccine against COVID-19 and also reported excellent results, with an efficacy of 95%, in the final analysis of their 45,000-person trial. In that study, which ended after 170 cases of COVID-19 were identified, only 10 severe cases occurred, and just one was in the vaccinated group.
Moderna and the Pfizer/BioNTech collaboration say their vaccines worked to about the same degree in all different groups, ethnicities, and genders. (More than 7000 participants were over age 65 and more than 5000 were under 65 but had diseases putting them at a higher risk of severe COVID-19; the study also included more than 11,000 people from communities of color.) That equal success is vital information for bodies trying to prioritize the use of the new vaccines, such as an advisory panel to the Centers for Disease Control and Prevention (CDC) that is meeting tomorrow. The committee’s recommendations influence CDC’s decisions about vaccine prioritization, but individual states come up with their own guidelines.
Moderna received $1 billion from the U.S. government’s Operation Warp Speed to help develop its mRNA vaccine. (Pfizer passed on such development money, but has signed an advanced purchase order for its vaccine with Warp Speed.) Moderna CEO Stéphane Bancel says all of the federal money went toward staging the clinical trials, and that without it, progress surely would have been delayed. Investors in May contributed another $1.3 billion to help the young company, which has no products on the market, build facilities to produce its vaccine.
Pfizer filed an EUA request for its vaccine last week, which led FDA to announce it will convene a meeting of its vaccine advisory committee to discuss the data in depth on 10 December. Bancel says FDA has told the company it might convene the committee again as early as 17 December to review its EUA application. He says the agency could issue an EUA 24 to 72 hours later.
Bancel imagines the Moderna vaccine, given its high efficacy against both mild and severe disease, will have the most impact if given to people at the greatest risk from SARS-CoV-2. “Give it to health care workers, give it to the elderly, give it to people with diabetes, overweight, heart disease,” he says. “A 25-year-old healthy man? Give him another vaccine.”
Moderna plans to charge $32 to $37 per dose of the vaccine in developed countries, Bancel says, but will have cheaper pricing for other parts of the world. The company is negotiating with the COVID-19 Vaccines Global Access (COVAX) Facility, a nonprofit that aims to reduce global vaccine inequities by purchasing and distributing approved products. “We want to have this vaccine available at a tiered price for low-income countries,” he says.
Bancel stresses that he wants other COVID-19 vaccines to succeed as well. “The world needs several manufacturers to make it to the finish line to stop this awful pandemic,” he says. U.K. pharma giant AstraZeneca, in partnership with the University of Oxford, has reported preliminary evidence of efficacy for its COVID-19 vaccine, as has the Gamaleya Research Institute of Epidemiology and Microbiology in Russia.
Moderna hopes to provide the U.S. government with 20 million doses by the end of the year, and Pfizer says it should have 50 million doses to split between the United States and other countries that made advanced purchase agreements.

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