novavax 批准了? 老人高危，实在想打，研究研究这个吧。因为3D设计不同，有可能避免spike的种种负面作用。

[贵圈]

如题，

有时间我研究一下，哪位懂重组蛋白疫苗的。给讲讲。

 

[我是谁?]

顶一下，哪位对这个的安全性有研究？

 

[Jay Wang]

co顶，请圈儿哥研究

 

[aottawa]

没研究，但这种应该和灭活疫苗差不多，也是一种疫苗蛋白，只不过是通过人工方法合成部分病毒蛋白，比如棘突蛋白。因为只是部分蛋白，所以可以比灭活病毒蛋白少产生一些不必要的免疫反应，这是好处，坏处是抗体种类没有灭活广，所以一旦病毒变异，和mRNA疫苗类似，容易失效。重组蛋白最大的好处就是和灭活差不多，因为是只是蛋白，所以安全性高。

 

[知更鸟]

那有什么正面作用吗？

 

[春夏之交]

没研究，但这种应该和灭活疫苗差不多，也是一种疫苗蛋白，只不过是通过人工方法合成部分病毒蛋白，比如棘突蛋白。因为只是部分蛋白，所以可以比灭活病毒蛋白少产生一些不必要的免疫反应，这是好处，坏处是抗体种类没有灭活广，所以一旦病毒变异，和mRNA疫苗类似，容易失效。重组蛋白最大的好处就是和灭活差不多，因为是只是蛋白，所以安全性高。

mRNA进入体内也是翻译成为蛋白质。
区别是直接还是间接输入蛋白质。

 

[贵圈]

这个疫苗据说spike的外形设计，跟mRNA催出来的不一样。

也许可以避免一些副作用。

而且是打进去多少就是多少spike。spike量是可控的。与人体对mRNA的应答不同。后者最终产出来多少spike，因人而异。过少过多，都是问题。

 

[廊坊头条]

这是 2021/11/11 的新闻报道，Novavax 已向WHO和加拿大等国提交了申请，（2021/11/11开始的）未来6-8周将得到核准。有比这更新的消息吗？

《COVID-19疫苗》Novavax未來6-8周將取得全球五大區核准! 2022年產20億劑並將在年初啟動全球配銷 - 生技投資第一站-Genet 觀點

Novavax未來6-8周將取的全球五大區核准! 2022年初啟動全球配銷

www.genetinfo.com

 

[lindamy]

这是 2021/11/11 的新闻报道，Novavax 已向WHO和加拿大等国提交了申请，（2021/11/11开始的）未来6-8周将得到核准。有比这更新的消息吗？

《COVID-19疫苗》Novavax未來6-8周將取得全球五大區核准! 2022年產20億劑並將在年初啟動全球配銷 - 生技投資第一站-Genet 觀點

Novavax未來6-8周將取的全球五大區核准! 2022年初啟動全球配銷

www.genetinfo.com

PHASE 3 EMERGENCY USE IN EUROPE, INDONESIA, PHILIPPINES

VACCINE NAME: NVX-CoV2373 (also known as Covovax or Nuvaxovid)
EFFICACY: 90.4%
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator

With massive support from the U.S. government, Maryland-based Novavax developed a highly effective protein-based vaccine. But manufacturing woes drastically slowed its rollout. It wasn’t until November 2021 that the company began gaining emergency authorizations, including from the World Health Organization, India, South Africa and the European Union. On Dec. 31, 2021, Novavax submitted a data package to the Food and Drug Administration, in advance of an application for emergency authorization in January 2022.

VACCINE DEVELOPMENTBefore the pandemic, Novavax developed a number of vaccines for diseases by attaching viral proteins to microscopic particles. In 2019, the company’s flu vaccine finished Phase 3 clinical trials, but it had yet to deliver a single vaccine to market.

In May 2020, the company launched trials for a Covid-19 vaccine, which they named NVX-CoV2373. The Coalition for Epidemic Preparedness Innovations invested $384 million to support the research. In July, the U.S. government awarded Novavax another $1.75 billion to support the vaccine’s clinical trials and manufacturing.

TRIAL RESULTSAfter getting promising results from preliminary studies in monkeys and humans, Novavax launched a Phase 2 trial on 2,900 people in South Africa in August 2020, and the next month it launched a Phase 3 trial with up to 15,000 volunteers in the United Kingdom. The Phase 3 trial in the United States was delayed because of problems with manufacturing the doses required for the study. It finally launched on Dec. 28, 2020.

On March 11, Novavax reported that its United Kingdom trial determined an efficacy rate of 96 percent against the original coronavirus, and an efficacy of 86 percent against the Alpha variant. In a study on nearly 30,000 volunteers in the United States in Mexico, the vaccine’s efficacy was 90.4 percent.

AUTHORIZATIONDespite the strong performance of NVX-CoV2373 in clinical trials, Novavax’s path to authorization has been long and difficult. The company has been dogged by delays in manufacturing and has struggled to develop reliable tests of its vaccines’ quality. In August 2021, the United States government said that it would not fund further production of Novavax’s vaccine until the company resolved concerns of regulators about its work.

Politico reported on Oct. 19 that Novavax was still struggling to manufacture enough doses to meet its targets, causing the company’s stock to drop 24 percent.

DISTRIBUTIONNovavax reached an agreement in September 2020 with the Serum Institute of India, a major vaccine manufacturer, that could enable it to produce as many as 2 billion doses a year. It now has an agreement with other countries, including the United Kingdom, Canada, Australia and South Korea. On Feb. 18, Novavax announced it would supply 1.1 billion doses to COVAX, a consortium that seeks to distribute vaccines to all countries across the world. In a Nov. 4 earnings call, Novavax said that it was anticipating producing over 2 billion doses in 2022.

VARIANTSBecause Novavax was slow to reach clinical trials, it was one of the first companies to measure the efficacy of its vaccines against variants that emerged starting in early 2021. In a small clinical trial in South Africa, Novavax found that the Beta variant drastically reduced the efficacy of the vaccine to less than 50 percent. That efficacy may have been unusually low because some of the volunteers in the study had H.I.V. and thus had weakened immune systems. Novavax estimated that the efficacy of the vaccine against Beta was 60 percent in people without H.I.V. On Dec. 22, Novavax announced that its vaccine also lost some of its potency against the Omicron variant, but a booster shot restored much of its protection.

BOOSTERSOn Dec. 21, 2021, Novavax announced that it was extending its Phase 3 clinical trial into a booster trial. They will give volunteers a third shot of NVX-CoV2373 to observe its safety and efficacy. In a separate trial, British researchers tested Novavax’s vaccine in a “mix-and-match” trial, in which volunteers switched from one vaccine to another for a booster. The researchers found that NVX-CoV2373 raised coronavirus antibodies to high levels.

For more details, see How the Novavax Vaccine Works.

EMERGENCY USE IN: India NEW, Indonesia, Philippines. Conditional authorization in the European Union NEW. Emergency use validation from the World Health Organization NEW.

Updated Jan. 12

 

[aottawa]

mRNA进入体内也是翻译成为蛋白质。
区别是直接还是间接输入蛋白质。

区别大了去了，用白话说，mRNA疫苗就是一种只能复制一次的病毒，它必须进入细胞内才能产生蛋白，它在细胞内制造和分泌蛋白是可能对人体造成损害。而蛋白重组就是打进人体的一块肉，根本进不了细胞，除了能引起免疫反应，对细胞作用有限。所以安全性是天壤地别。

 

[billwanhua]

重组蛋白疫苗是成熟技术，novavax这个疫苗应该比较牛逼，因为后研制出来，三期实验受变异影响，但是依然能接近mRNA疫苗的有效性，所以实际有效性有可能更高。

关键是novavax卡在生产上面，不能大规模生产出来，后来生产出来被FDA说跟三期实验的东西不一样。最近novavax跟印度达成协议生产，不知道最终产品比三期实验差多少，估计不好。

中国最近开发的大部分疫苗都是重组蛋白，好像效果都不错(都在做三期，1、2期抗体都很高)

古巴两款都是这种疫苗，好像效果很好，古巴疫情也不严重

 

[billwanhua]

Why Cuba's extraordinary Covid vaccine success could provide the best hope for low-income countries

Cuba remains the only country in Latin America and the Caribbean to have produced a homegrown shot for Covid.

www.cnbc.com

这个有古巴重组蛋白疫苗的最新报道，三期实验都是90%有效，而且都是最近做的实验，如果真是在有变异的情况下的真实数据，感觉比mRNA靠谱。
大家可以看看古巴的疫情感染情况，比其他地方好多了。

中国安徽等地大规模使用的智飞也是重组蛋白。
印尼药物与食品监管局(BPOM)正式为5种新冠疫苗加强剂发布紧急使用授权。5种加强剂疫苗分别是的Coronavac、辉瑞(Pfizer)，阿斯利康(AstraZeneca)、莫德纳(Moderna)，以及智飞疫苗(Zifivax)。
公开资料显示，该疫苗于2021年3月1日，在乌兹别克斯坦获得注册上市，成为国际首个注册上市的重组亚单位新冠疫苗；2021年3月10日，在国内获批紧急使用；2021年10月7日，在印度尼西亚获批紧急使用。国际多中心Ⅲ期临床试验结果表明，该疫苗对于任何严重程度的COVID-19的保护效力为81.43％，达到世界卫生组织WHO要求的新冠疫苗有效性标准。基因分型初步分析结果显示该疫苗对Alpha变异株的保护效力为92.68％，对Delta变异株的保护效力为81.38％。

 

[春夏之交]

区别大了去了，用白话说，mRNA疫苗就是一种只能复制一次的病毒，它必须进入细胞内才能产生蛋白，它在细胞内制造和分泌蛋白是可能对人体造成损害。而蛋白重组就是打进人体的一块肉，根本进不了细胞，除了能引起免疫反应，对细胞作用有限。所以安全性是天壤地别。

如果直接输入蛋白质那么好，怎么会有公司脱裤子放屁要输入蛋白质模板mRNA呢？因为蛋白质不稳定，保持具有活性的三维结构很难。生产、储存，运输都有困难。而mRNA进入体内它只能翻译成预先设定的三维结构的蛋白质。mRNA进入体内生存时间不长就会被分解，相当安全。

 

[贵圈]

mRNA技术基本上安全。关键还是看产出的免疫刺激物是什麽。

目前两个mRNA都是生产spike。问题是spike的安全性有大问题。

 

[春夏之交]

mRNA技术基本上安全。关键还是看产出的免疫刺激物是什麽。

目前两个mRNA都是生产spike。问题是spike的安全性有大问题。

即使大量spike产生，如果当时没有严重问题，比如心肌炎，说以后会有长期副作用，完全是瞎扯，因为这些蛋白质是一次性的，也很快分解。