A final analysis of the Phase 3 trial of Pfizer''''s coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday. The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said. An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said. The Phase 3 clinical trial of the vaccine began on July 27. Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said it wanted at least two months of safety tracking on volunteers after they got their second shots. The 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years. https://www.cnn.com/2020/11/18/health/pfizer-coronavirus-vaccine-safety/index.html
Good news indeed. With 2 highly effective vaccines, we should be able to achieve herd immunity twice as fast. I'm a healthcare worker, I hope all the health care vaccinated by the end of the year or January so we may confront this winter's wave with a full staff.
I kinda agree i guess we need more details to understand a little more perhaps the crowns’ structures got denatured during the virus inactivation? Vaccines from an mRNA source can resemble the real viral proteins more? but seriously there is too much unknown here. I think people should take it (or not take it) willingly
An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said.
The Phase 3 clinical trial of the vaccine began on July 27. Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said it wanted at least two months of safety tracking on volunteers after they got their second shots.
The 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years.
https://www.cnn.com/2020/11/18/health/pfizer-coronavirus-vaccine-safety/index.html
疫苗总算是有了,下面还有扩大产量的问题。
When will the result be peer reviewed?
是数据收据的原因,还是感染的原因?
这个link给了一些用到的基本统计知识。
https://medium.com/swlh/the-fascinating-math-powering-the-covid-19-vaccine-trials-930a5e97c9c9
有道理,至少找齐志愿者,打两针疫苗都不是一下能办到的。现在只是坐等感染人数是应该快些。
太好了。希望明年夏天前生活回归正常。
至少有希望了。
都有吧,打完第二针后第7天才能开始收集数据,所以pool是越来越大的
不是大神,但我猜想是这样计算的:
8/162=5%
100%-5%=95%
没打疫苗的有162人感染,如果疫苗无效的话疫苗组应该也会有162左右的人感染,现在只有8人感染,也就是本来会感染的人中的5%,疫苗使95%的人避免了感染。
第二针是不是才打了几个星期?希望疫苗有长时间的效果。
flu shot 主要是病毒株种好几个,还不一定找得准吧,covid-19 病毒就一个。
flu shot的flu一直在变异,导致有效率降低。还有一个,积极参与疫苗试验的人相对来说比较健康,我自己想的,不做这行。
三期实验结束,安慰组会被告知,然后可以重新打疫苗。
每年流感疫苗,都是在猜测今年流行的病株。
经常猜不准
现在的数据应该可以算出Poisson分布,以后即使都打了疫苗也可以看出抗体持续时间。在hazard rate上做假设检验就可以了。
所有人都会继续观察两年,什么时候看到感染率开始上升就知道疫苗的有效期快到了。已经知道疫苗有用了还给志愿者打安慰剂是有伦理问题的,就像测试降落伞性能的时候不能搞一个安慰剂组。
有道理,所以其他有针对性的什么乙肝疫苗之类的有效性也会比较高了
100%
41% of trial participants are aged between 56 and 85 years old.
第一个readout原定是收集到32个有症状感染就开始,实际上等到了94个感染,时间是大选后第二天。。。
不过话又说回来,真要是十月底就公布前32个感染的分析结果,然后两党为了疫苗一阵猛撕,他们的疫苗还有人敢打吗?别忘了Pfizer拿的联邦政府的钱只是订单,前期的研发和临床实验都是自己掏的钱。
有一个问题参与试验的人都是没得过新冠的吧?那美国10m得过新冠的效果和风险未知吧?
扩大产量一般在三期开始的时候就同步进行了,一般在approval的时候已经产出一定的规模了
显然interim结果是特地等大选之后才公布的啊
因为流感病毒由于变异 每年有多株显著不同的病毒,而疫苗只能针对其中已经知道的少数几株,因为等到打疫苗时候,已经有不少新的病毒株变异出来了。新冠病毒现在看起来变异小很多,病毒株之间没有显著不同,给疫苗开发的成功带来了一定保证。
所以同是RNA病毒,新冠病毒变异小于流感病毒,从这方面讲,人类还是算幸运的。
应该的
流感是灭活疫苗,这种是mRNA. 可能是为什么效果好很多。算法应该是一样的
理论上讲不应该有问题,疫苗带来的抗原是新冠病毒抗原蛋白的一个子集,并没有让身体接触什么新的异体蛋白,理解成多加强一针就好了。
后遗症研究是另外一个长期的流程
现在三期结束是指揭盲,参与者会被告知是注射了安慰剂还是疫苗,注射安慰剂的人群,可以开始打真正的疫苗了。
据说流感疫苗是灭活的,有效率要低
应该是的,不过我在想今年这情况要是大选前公布会不会有人不肯打了,所以之后公布也能理解
我也这么想呢,这个疫苗一年产量能上10亿,开始抢市场了
再观察两年全得了,结果还会接着看,打也得开始da l
不用大神,小学生算数,162/170
没读懂 求解释
确实快 但没你说的那么快 7月份才开始 第一次event是28天后即8月份了 三个月只剩两个月 而且也不是所有人都是第一天就打了 假设均匀enroll的话 时间又被cut一半 所以90感染的平均followup只有一个月多一点 这也是为啥Pfizer没有两个月安全数据的原因吧
Flu 是灭活疫苗,有效率就是差。但是flu 死亡率低,又有特效药,所以这种有效率也足够了。
乙肝疫苗是重组疫苗,打三针。流感疫苗是灭活疫苗,打一针。
辉瑞自己都说了, 本来准备32个开始第一次中期分析, 结果和FDA沟通认为应该从第二个分析点大概56还是60个, 等沟通完毕开始分析已经有90多个了..
Flu的有效率是建立在是否猜中病株上,猜中了有效率就高,否则可能低到10%都不到都有过,跟是否灭活毫无关系吧
flu shot是灭活疫苗,这个是mRNA疫苗
猜中了有效率是70%, 猜不中10%
因为第一针和第二针本来就间隔20多天,然后打完第二针需要再等二十天左右体内抗体浓度水平够高了才开始计入感染人群,所以开始的90个看着慢,时间算一算都差不多。 美国和欧洲这第二波大型感染也正好赶上了时间,所以这两家都是迅速就积累了很多感染病症了
99.8%?
https://www.npr.org/sections/health-shots/2020/11/17/935563377/why-does-pfizers-covid-19-vaccine-need-to-be-kept-colder-than-antarctica
One big reason? One of the front-runners in the vaccine race — the one made by Pfizer — needs to be kept extremely cold: minus 70 degrees Celsius, which is colder than winter in Antarctica. Moderna has said that its vaccine needs to be frozen too, but only at minus 20 Celsius, more like a regular freezer.
这个-70C怎么操作注射呢?
我觉得事态会按照你预测的发展
零下70度是指库存时温度要求,注射前需要解冻。Pfizer疫苗解冻后可以在冷藏冰箱保存5天,Moderna疫苗解冻后可以在冷藏冰箱保存30天,也可以在室温下保存12个小时。
对, 就是这样计算的.
前几天看过一个免疫学博士审核过的一篇科普说过怎么算.
是啊,疫苗零下70度的存储也很好解决啊,把疫苗放在保温箱里然后拿7块零下10度的冰块进去就行了
你这么乱说话你老板知道吗?不能随便透露吧。
这个完全有可能,Pfizer新增的76例感染基本全是对照组的,Moderna凑够了164个人,接着用5一除,肯定高过95%。 我猜他们的结果是97%
I kinda agree
i guess we need more details to understand a little more
perhaps the crowns’ structures got denatured during the virus inactivation? Vaccines from an mRNA source can resemble the real viral proteins more?
but seriously there is too much unknown here. I think people should take it (or not take it) willingly
do they have the counts breakdown by age?
hope there is no Simpson’s paradox
thx
那等它做出来,疫情都过去了。辉瑞的12月就要上市了呀