The highest effective rate of Modena new crown vaccine was 100%. The application for emergency use was submitted on November 30

11月30日，新型冠状病毒肺炎（Moderna）宣布新冠状病毒mRNA-1273的有效性达到94.1%，重症新冠状病毒肺炎的有效率达到100%。它将向世界食品管理局（FDA）和欧盟药物管理局（EUA）和其他全球监管机构提交一份滚动申请，以获得疫苗的使用权。

On November 30th, novel coronavirus pneumonia (Moderna) announced that the effectiveness of the new crown vaccine mRNA-1273 reached 94.1%, and the effective rate of severe new crown pneumonia reached 100%. It will submit a rolling application to the world food regulatory agency (FDA) for the right to use the vaccine (EUA) and the European Union drug administration and other global regulatory agencies.

安慰剂组185例出现新型冠状病毒肺炎，mRNA-1273组11例，根据mod Na官方报告，196例有效率为94.1%。

Novel coronavirus pneumonia was observed in 185 cases of placebo group, while 11 cases were observed in group mRNA-1273, according to official reports released by mod Na, 94.1% of the results were effective based on 196 cases.

此前，在11月16日，摩德纳宣布对95例病例的评估显示，mrna-1273在新型冠状病毒疫苗研究中的有效率达到94.5%。摩德纳说，三期研究的最新主要疗效分析证实了第一次中期分析中观察到的高疗效。

Previously, on November 16, Modena announced that the evaluation of 95 cases showed that the effective rate of mrna-1273 in the research of new coronal vaccine reached 94.5%. The latest major efficacy analysis for the phase III study confirmed the high efficacy observed in the first interim analysis, Modena said.

对于100%的有效率，分析次要终点。分析包括30例严重病例，全部发生在安慰剂组，而mrna-1273疫苗接种组中没有一例。摩德纳因此认为疫苗能有效预防新型冠状病毒肺炎，有效率为100%。

As for the 100% response rate, the secondary endpoint of the analysis was analyzed. The analysis included 30 severe cases, all of which occurred in the placebo group, and none of the mrna-1273 vaccination groups. Modena therefore said that novel coronavirus pneumonia was effectively prevented by the vaccine, and the effective rate was 100%.

莫德纳在一份官方声明中说，紧急使用权申请将于11月30日提交给美国食品和药物管理局，美国食品和药物管理局疫苗及相关生物制品咨询委员会（vrbpac）可能会在12月17日（星期四）开会，审查mrna-1273的安全性和有效性数据包。摩德纳希望疾病预防控制中心的免疫实践咨询委员会（ACIP）就免疫优先事项提出建议。

Modner said in an official statement that an application for emergency use rights will be submitted to the US FDA on November 30, and the FDA advisory committee on vaccines and related biological products (vrbpac) may meet on December 17 (Thursday) to review the safety and effectiveness data package of mrna-1273. Modena expects the CDC's Advisory Committee on Immunization Practices (ACIP) to make recommendations on immunization priorities.

莫德纳说，公司新研制的皇冠疫苗在美国获准紧急使用后不久，预计将运送到美国各地的指定分发点。

Modner said the company's new crown vaccine is expected to be delivered to designated distribution points throughout the United States shortly after it is authorized for emergency use in the United States.

此外，摩德纳还计划向欧盟、加拿大、瑞士、以色列、英国、新加坡等国家和地区的监管部门提交滚动申请，并寻求世界卫生组织的资格预审（PQ）或紧急用途清单。

In addition, Modena plans to submit rolling applications to the regulatory authorities of the European Union, Canada, Switzerland, Israel, the United Kingdom, Singapore and other countries and regions, and seek the prequalification (PQ) or emergency use list of the World Health Organization.

摩德纳强调，到2020年底，该公司预计将在美国运送约2000万剂新型冠状病毒疫苗，预计到2021年，全球将生产5亿至10亿剂冠状病毒疫苗。

Modena stressed that by the end of 2020, the company is expected to ship about 20 million doses of new coronavirus vaccine in the United States, and is expected to produce 500 million to 1 billion doses worldwide by 2021.

Mordena新冠疫苗和辉瑞/biontech新冠疫苗属于mRNA新冠疫苗，运输条件要求严格。此前，摩德纳曾表示，该疫苗在2℃至8℃（36℃至46℉）即标准家用或医用冰箱的温度下可稳定30天；在零下20℃可稳定长达6个月；在冷藏条件下可稳定30天，室温下可稳定12小时。

Mordena new crown vaccine and Pfizer / biontech new crown vaccine belong to the mRNA new crown vaccine, which requires strict transportation conditions. Previously, Modena has said that the vaccine can be stable for 30 days at 2 ℃ to 8 ℃ (36 ° to 46 ° f), that is, the temperature of a standard household or medical refrigerator; it can be stable for up to six months at minus 20 ℃; it can be stable for up to 30 days under cold storage and 12 hours at room temperature.

摩德纳在最新声明中强调，在确保新的皇冠疫苗能够利用现有基础设施进行分发、储存和加工方面取得了进一步进展。

In his latest statement, Modena stressed that further progress has been made in ensuring that the new crown vaccine can be distributed, stored and processed using existing infrastructure.

Link：https://new.qq.com/omn/20201130/20201130A0FYD000.html

update time：2020-12-01 10:37:26