英文原文: 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.
Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
“生物技术公司Moderna发布有关COVID-19疫苗的后续消息,他们在今天在新闻稿中宣布了该候选疫苗在30,000人有效试验的最终结果:接受了两剂疫苗的人群中只有11人出现新冠状病毒感染的症状,安慰剂组中有185个有症状的病例。该公司表示,这是94.1%的保护效果,远高于几周前许多疫苗科学家的预期。
更令人印象深刻的是,Moderna的候选疫苗对严重新冠疾病具有100%的预防功效。接种疫苗的人群中重症COVID-19病例为零,而安慰剂组为30例。该公司今天计划向美国食品药品监督管理局(FDA)申请其疫苗的紧急使用授权(EUA)要求,并且还在寻求欧洲药品管理局的类似批准。
Moderna计划在发达国家中对每剂疫苗收取32至37美元的费用,但在世界其他地区的价格将更低。该公司正在
与非营利组织COVID-19疫苗全球应用机构进行谈判,该机构旨在通过购买和分发经批准的产品来减少全球疫
苗不平等现象。希望以低廉的价格为低收入国家提供这种疫苗。”
英文原文: 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.
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study
Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
疫苗组感染率: 11/185=0.05946
对照组感染率: 174/185=0.94054
保护率=(0.94054-0.05946)/0.94054=93.68%
我理解疫苗保护有效率:(打疫苗总人数- 未被感染人数) / 打疫苗总人数, 再X 100%
安慰组也类推计算,这个94.1%应叫 2组被感染率的比较结果,不是通常意义上的疫苗保护有效率,玩猫腻呢?
大样本随机分组
对照组N人,有185人感染。
疫苗组N人,有11人感染。
疫苗组的N人,如果没有打疫苗,将会有185人感染。由于疫苗的效果,这185人,降为11人。换句话说,疫苗保护了(185-11)人。
疫苗的保护率:(185-11)/185=94.05%
至于那(N-185)没有感染病毒的人,要么是本身就有抵抗力,要么是根本没有接触到病毒。这些人与疫苗无关。
30个重症,95%的保护率,也就是一个人;100%是没人。中间只有一个人头的差别,所以这个结论下的太早。
一百多例是三期临床的试验出结果的条件,达到这个条件,三期临床结束,开始进行结果评估。
如果继续观察试验,剩下的(N-185)里面还会有人陆续中招。
样本还不够多。