天啊,搞了半天莫德納疫苗在今天以前一直都沒有被FDA正式批准啊!接種了該疫苗的人此前知道不?

  • 主题发起人 主题发起人 TianK
  • 开始时间 开始时间
這問題你問藥廠去,最好還問一下FDA:為啥最後批准要一直拖到今天,之前究竟有啥顧慮?是實驗數據不夠全?還是藥廠仍有些事情沒有解釋清楚?
紧急批准的时候,没有完成全部年龄段的三期实验,一年前各国接种的辉瑞和Moderna 都只是对18岁以上成年人,所以都只获得紧急批准。解释得一清二楚。

什么都不懂,把自己无知当别人的阴谋。
 
这些疫苗如果现在做临床试验,过不了50%有效性的关口。
 
这些疫苗如果现在做临床试验,过不了50%有效性的关口。
很有可能,去年6月,德国的一个疫苗赶上Delta,在老龄组效果不佳,总体没有达到50%,放弃了。

ABANDONED

CureVac logo


VACCINE NAME: CVnCoV
EFFICACY: 48%
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: Stable at least 3 months at 36–46°F (2–8°C)

The German company CureVac generated a lot of hope for its mRNA vaccine for Covid-19 in 2020, only to see it deliver disappointing results in clinical trials the following year.

The company, founded in 2001, had years of experience developing experimental mRNA vaccines for a host of diseases. In early 2020, they began work on a Covid-19 vaccine, called CVnCoV. In March, the Trump administration unsuccessfully tried to entice CureVac to move its research on their mRNA vaccine from Germany to the United States.

The company plowed ahead with its work in Germany, seeing responses to the vaccine in mice and monkeys before launching clinical trials in July. CVnCoV showed promise in several respects: it could remain stable in a refrigerator rather than a freezer, and preliminary studies suggested it would work well at a low dose, reducing its cost.

In December, CureVac launched a Phase 3 trial, recruiting up to 36,500 volunteers in Germany. The European Union began a rolling review in February, intended to speed up approval if the Phase 3 trial delivers positive results.

Meanwhile, CureVac prepared for mass production of the vaccine. The company negotiated a deal to provide the European Union with up to 400 million doses of their vaccine. They projected manufacturing up to 300 million doses in 2021 and up to a billion doses the following year. Starting in January 2021, CureVac forged a series of partnerships with pharmaceutical giants Bayer, Celonic, GSK, and Novartis, to support the production of their vaccine and develop new ones against coronavirus variants.

In June 2021, CureVac reported disappointing results from their Phase 3 trial. Overall, CVnCoV had an efficacy of just 48 percent against Covid-19. It proved somewhat better for younger volunteers: For those between the ages of 18 and 60, the efficacy rose to 53 percent. In that group, the researchers also found the vaccine provided 100 percent protection against hospitalization and death. Researchers later pointed to the vaccine dosage along with the rise of new variants as potential reasons for the low efficacy. On Sept. 14, CureVac announced that it had cancelled its manufacturing deals with Celonic and German company Wacker, citing a decline in demand for CVnCoV.

Despite the disappointing results, the company moved ahead with preparing an application to the European Union for emergency authorization for the use of the vaccine in people 60 and under. But European regulators gave no indication they would continue speeding along their review. As a result, on Oct. 12, CureVac announced that it would withdraw CVnCoV from the regulatory approval process.

Instead, CureVac is focusing its efforts on a next-generation vaccine for Covid-19, called CV2CoV, that it is developing with GSK. This updated version produces more spike proteins, and thus a stronger immune response. In November, researchers at Harvard published a study in the journal Nature showing that monkeys given CV2CoV produced antibodies to the coronavirus at a level comparable to the Comirnaty vaccine from Pfizer and BioNTech. Reuters reported in November that CureVac was planning on starting a Phase 1 trial on CV2nCoV within the next few months.

Updated Nov. 26
 
注意了,spikevax

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还是控制媒体好,严格的双盲实验不能防止死亡,可以创造数据

疫苗被正式批准是因为阻止感染,数据没有证明防止死亡,现在媒体自己创造了数据,摇身一变,变成阻止死亡了

以后医学也不用双盲实验了,媒体写什么就是结果了,就像第三针对Omicron
 
最后编辑:
可是死是防不了的啊。任何病都可导致死,就是死的机率高不高而已。摔了头的死亡率高于扭了脚的。
应该是此苗虽不能完全阻止死亡,但能降低死亡率吧。但考虑到此毒的致死率很低,官方数据不明,民间有传最大约1%吧(你们如有更准确数据,请通知一下),死的命都是宝贵的命,死一个不比死一千个更让人庆幸。无论死多少人,都要为之伤心难过。可是动用100%的接种率,来对付1%的死亡率,理论上讲精诚可贵,在现实上不太可行吧,有点儿理想主义色彩。既然任何病都可致死,也许把这么大的阵仗用到对付高致死率的疾控上更有效点。
 
可是死是防不了的啊。任何病都可导致死,就是死的机率高不高而已。摔了头的死亡率高于扭了脚的。
应该是此苗虽不能完全阻止死亡,但能降低死亡率吧。但考虑到此毒的致死率很低,官方数据不明,民间有传最大约1%吧(你们如有更准确数据,请通知一下),死的命都是宝贵的命,死一个不比死一千个更让人庆幸。无论死多少人,都要为之伤心难过。可是动用100%的接种率,来对付1%的死亡率,理论上讲精诚可贵,在现实上不太可行吧,有点儿理想主义色彩。既然任何病都可致死,也许把这么大的阵仗用到对付高致死率的疾控上更有效点。

双盲实验新冠死亡率是一样的,那个正式批准疫苗的临床实验,给FDA的报告,前2个月很多人就看到了。最后疫苗组死了21个,对照组死了17个,好像是这个数字。当然大部分死的是其他疾病。

到了真实世界,因为不是严格双盲实验,很多绝症或者免疫缺陷患者,或者一些其他严重疾病不适合打疫苗,这些人死亡率和重症率高。就给了疫苗有保护重症数据上的机会
 
为了强制疫苗。把疫苗给毁了
 
可是死是防不了的啊。任何病都可导致死,就是死的机率高不高而已。摔了头的死亡率高于扭了脚的。
应该是此苗虽不能完全阻止死亡,但能降低死亡率吧。但考虑到此毒的致死率很低,官方数据不明,民间有传最大约1%吧(你们如有更准确数据,请通知一下),死的命都是宝贵的命,死一个不比死一千个更让人庆幸。无论死多少人,都要为之伤心难过。可是动用100%的接种率,来对付1%的死亡率,理论上讲精诚可贵,在现实上不太可行吧,有点儿理想主义色彩。既然任何病都可致死,也许把这么大的阵仗用到对付高致死率的疾控上更有效点。


心脏病死亡率更高,但是在短时间大家都传染心脏病的可能性大吗?
 
可是死是防不了的啊。任何病都可导致死,就是死的机率高不高而已。摔了头的死亡率高于扭了脚的。
应该是此苗虽不能完全阻止死亡,但能降低死亡率吧。但考虑到此毒的致死率很低,官方数据不明,民间有传最大约1%吧(你们如有更准确数据,请通知一下),死的命都是宝贵的命,死一个不比死一千个更让人庆幸。无论死多少人,都要为之伤心难过。可是动用100%的接种率,来对付1%的死亡率,理论上讲精诚可贵,在现实上不太可行吧,有点儿理想主义色彩。既然任何病都可致死,也许把这么大的阵仗用到对付高致死率的疾控上更有效点。
假设omicron的死亡率是delta的1/2,感染率是10倍,死亡人数增加5倍。安省,加拿大多数人7,8月接种,有效地防止了delta造成的死亡。

美国接种疫苗比加拿大早,比率低。delta死亡的保护率比较一下:

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1643722285586.png


1643722324393.png
 
我也诚心希望你们说的是真的,老百姓还不就求个各种机构都正常按行业规矩运作,让人平安度日。
可是我观看这三年来全世界上在各行各业发生的事,心里直犯嘀咕,哪个数据可信呢?医疗一线,疫苗研发、制造,新闻媒体,社交媒体,防疫决策机构、执行机构,其中独立运作不被偏见左右(有点儿象双盲吧)的有多少呢?或者降低标准,能维持80%独立性运作的有多少?
 
我也诚心希望你们说的是真的,老百姓还不就求个各种机构都正常按行业规矩运作,让人平安度日。
可是我观看这三年来全世界上在各行各业发生的事,心里直犯嘀咕,哪个数据可信呢?医疗一线,疫苗研发、制造,新闻媒体,社交媒体,防疫决策机构、执行机构,其中独立运作不被偏见左右(有点儿象双盲吧)的有多少呢?或者降低标准,能维持80%独立性运作的有多少?
不知道有多少真实度,但是没有道理选择相信delta,怀疑omicron的数据。
 
不知道有多少真实度,但是没有道理选择相信delta,怀疑omicron的数据。
嗯。不知象印度、日本等国家可否参照?哪个国家没有大规模施打针对DELTA毒的疫苗,要有这样的数据就可对比?
 
嗯。不知象印度、日本等国家可否参照?哪个国家没有大规模施打针对DELTA毒的疫苗,要有这样的数据就可对比?
不明白你指的是什么?印度日本的疫情得问贵圈。
 
不明白你指的是什么?印度日本的疫情得问贵圈。
我指,哪个国家没有大规模施打针对DELTA毒的疫苗,日本和印度属于这样的国家吗?
 
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