回复 10楼cocosmores的帖子 novavax 又推迟了。 Novavax delays vaccine approval plans to third quarter Nikou Asgari Novavax has pushed back its timeline and will apply for authorisation of its vaccine in the UK, US and Europe in the third quarter of the year as the company struggles to quickly collate the data required for submission. “It’s just a long process,” Stanley Erck, chief executive of Novavax, told the Financial Times. “Our guidance had been that we’d get the project done by the second quarter and I’m now saying … we can’t get it all done by the end of June so it’s going to slip into the third quarter unfortunately.” His comments came as the biotech reported first-quarter revenues of $447m, surpassing analysts’ expectations of $234m and surging beyond the $3m worth of sales that it booked in the same period last year. The US and UK are not reliant on the Novavax jab for immunising their populations because orders from other authorised drugmakers have been met. But if authorised, the protein-based vaccine would boost the global supply of jabs and benefit developing countries, especially because the jab can be easily stored in a refrigerator. Novavax’s two-dose vaccine has proved 96 per cent efficacy against the original strain of coronavirus and 86 per cent efficacy against the variant first detected in the UK. “It’s the volume of work,” Erck said about the delay, adding that the company has gone from a staff of 150 to 900 over the past year. “I must have 100 consultants that are working on it.” Novavax’s UK clinical trial data are complete but it is working on collecting manufacturing data that would show the drugmaker can safely and repeatedly make the same vaccine doses. Its US clinical trial is expected to finish in the second quarter of the year. The Maryland-based company made a net loss of $223m in the three months to March. Analysts had expected a net loss of $256m. Erck said the biotech has struggled with a shortage of raw materials including bags, filters and cell culture media. He said it was “painful” that one Novavax plant did not operate for three weeks because of a shortage of materials, which has now been resolved. If all its plants are operating at full capacity, Novavax should be able to make 150m doses every month, he added. Novavax’s share price has rocketed nearly 4,000 per cent since the start of 2020. Its shares rose 3 per cent in after-market trading on Monday after closing 9 per cent lower.
12，13岁的父母的意见可能份量重些，
这个年龄段的孩子思维一般是受学校、老师影响的，不过18岁以下应该都要父母签字吧
唉，还是七上八下
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal
In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated
理解你，这个决定家长真不容易做
本来打算明年去日本度假的，看来算了吧。
novavax 又推迟了。
Novavax delays vaccine approval plans to third quarter Nikou Asgari Novavax has pushed back its timeline and will apply for authorisation of its vaccine in the UK, US and Europe in the third quarter of the year as the company struggles to quickly collate the data required for submission. “It’s just a long process,” Stanley Erck, chief executive of Novavax, told the Financial Times. “Our guidance had been that we’d get the project done by the second quarter and I’m now saying … we can’t get it all done by the end of June so it’s going to slip into the third quarter unfortunately.” His comments came as the biotech reported first-quarter revenues of $447m, surpassing analysts’ expectations of $234m and surging beyond the $3m worth of sales that it booked in the same period last year. The US and UK are not reliant on the Novavax jab for immunising their populations because orders from other authorised drugmakers have been met. But if authorised, the protein-based vaccine would boost the global supply of jabs and benefit developing countries, especially because the jab can be easily stored in a refrigerator. Novavax’s two-dose vaccine has proved 96 per cent efficacy against the original strain of coronavirus and 86 per cent efficacy against the variant first detected in the UK. “It’s the volume of work,” Erck said about the delay, adding that the company has gone from a staff of 150 to 900 over the past year. “I must have 100 consultants that are working on it.” Novavax’s UK clinical trial data are complete but it is working on collecting manufacturing data that would show the drugmaker can safely and repeatedly make the same vaccine doses. Its US clinical trial is expected to finish in the second quarter of the year. The Maryland-based company made a net loss of $223m in the three months to March. Analysts had expected a net loss of $256m. Erck said the biotech has struggled with a shortage of raw materials including bags, filters and cell culture media. He said it was “painful” that one Novavax plant did not operate for three weeks because of a shortage of materials, which has now been resolved. If all its plants are operating at full capacity, Novavax should be able to make 150m doses every month, he added. Novavax’s share price has rocketed nearly 4,000 per cent since the start of 2020. Its shares rose 3 per cent in after-market trading on Monday after closing 9 per cent lower.
novavax的adolescent trial 到现在人都还没找够，现在pfizer 可以打12岁以上了，他们更加难凑够人数了。
Novavax 管理层能力太差，又跳票了。现在18岁以上的EUA从5月底推迟到8月底，12－17岁1周前刚开始临床，怕是要等年底了。
novavax生产有很大问题，今天Q1报告一出股价大跌，他们如果生产力达不到FDA最低要求就没法申请EUA
12岁以下预计是明年初，但是以pfizer目前的效率来看，很可能提前。
因为mRNA技术是第一次用于人，所以有很多中长期的不确定性。自己用可以，孩子还是要斟酌一下。
Novavax是传统技术，安全性没有问题。
Novavax 因为没有自己的药厂，只能四处找合作的小药厂。英国首相出面才让GSK帮忙，而在美国没有政要和大药厂支持。
管理层低估了困难，行动缓慢，造成延迟。目前只生产出4000万剂，第三季度的月产量8000万剂。
强生不也是传统技术？安全性没问题吗？
其实强生用的腺病毒疫苗技术是用于 Ebola， 但接种人群不够大，所以没有发现问题。或者出现了问题，而被忽视了。
这次不同，上亿人接种，问题才暴露。
看新闻说9月就可以submit给FDA。估计FDA也就两周review一下就批了。
一样的。这个年纪打的几乎所有的疫苗都是和成人剂量一样的。普通流感疫苗3岁以下剂量是成人一半，三岁以上就和成人的剂量一样了。
有些人就是来搅浑水的，不用理。 从基本的科学原理来说，疫苗应该是越干净越简单越安全。
这公司这个速度，再等下去黄花菜都凉了
小娃年龄还不到12岁...
novavex也不见得多好
Pfizer已经打了上亿了 事实证明效果非常好。
所以安全性是根据复杂程度判断的？ 作为不懂行的看了你说的觉得含有多种化合物的西红柿和三氧化二砷相比安全问题大太多了
你这种拿西红柿和三氧化砷耒比就是胡搅蛮缠。这些疫苗大都用s 蛋白去引发人体免疫反应。特异性和选择性也是药物设计时要注意的，不然好多off target 毒性。已经有临床试验和真实世界的安全性数据了，都是新疫苗，但为什么好多人认为因为是传统技术就安全？
据说接种疫苗的小孩子20%会发烧。
Matrix
没办法 韭菜越割越小
额，你确定么
在生物技术公司做了十多年了，懂行的在此。
你说的每个字都很有道理。传统减毒疫苗安全性不高、灭活疫苗好点。mRNA 疫苗做到了精准，安全性和有效性得到了本质的提高。
mRNA疫苗技术已经有了十多年了。为什么这么多年没发展产品？很简单、做疫苗没钱赚。临床投资又灰常巨大。
据说Pfizer要FDA加紧批准9月份2到12岁打疫苗。我会让我家两个小的到时候去打。不然每次因为班上有人或者我娃发烧等检测结果的时候，都是提心吊胆的。这么小的娃捅鼻子挣扎哭的撕心裂肺的。
传统技术是大量结果验证的了，已经证明是安全的。新技术还没有经过长时期的考验。有啥难理解的？
我也是这样的认为，疫苗越干净越好！我家打了辉瑞和M的疫苗，现在准备让孩子去打。
网上有真担心的，很多也是故意带节奏的。
西红柿和西红柿比好吗？不是同一种东西有什么可比的？
人家比的是不同的疫苗技术，或者比不同的疫苗，你让大家比西红柿和砒霜，逻辑在哪里？
青少年不需要打？难道直接感染病毒更好吗？！
大人的三期要今年8月才结束，孩子的三期现在就结束了？呵呵
打了的人可以自己想想这个试验期的疫苗long term大概会有啥后遗症副作用，呵呵。
你觉得给你娃打个长期副作用不明的试验期疫苗更好那就更好啰，没人拦着你给你自己娃打疫苗
很多人其实不是内行，专业也不搭边，上网搜了很多信息就一副众人皆醉我独醒的姿态
德国、加拿大和美国都开放辉瑞给青少年打了，已经有了不少数据，很快欧盟其它国家也会跟上。Novavax估计要等到猴年马月啊。。。。。。
疫苗黑要对任何疫苗都黑，不要就黑mRNA，现在强国墙里黑mRNA要小心容易被抓进去挖沙子
同意
呵呵个啥啊，人家哪里说三期结束了？ 人家申请的是EUA，自己去看看申请EUA的条件再来呵呵吧。
打了是爱，还是不打是爱？你这调调我不敢苟同
这都是什么呀。大人的辉瑞和Moderna 三期去年年底就结束了，哪里看到的8月才结束？
紧急使用authorization的要求是有打了疫苗三期志愿者的2个月的跟踪数据，formal approval要求要至少6个月。
说到它的技术传统和安全，但是这个佐剂是新专利吧，我记得之前版上小浣熊对这个重组蛋白技术很有预期，但是也把这个佐剂叫做”逆天黑科技“，具体为什么我一直不了解。有专业人士烦请答疑。如果我没有记错的话，疫苗可能会因为佐剂的问题而疑似对神经系统有干扰，曾经北欧的一个新开发的疫苗疑似佐剂造成少量接种者嗜睡，而终止使用。
还有novavax这个全球找生产商的情况也会有潜在问题。比如磨合生产技术，保证产品质量的稳定性。之前就是巴尔的摩的生产厂在开始生产强生疫苗的时候出现一次事故。幸好在美国这个地方，这种生产事故不会被隐瞒。如果是在印度，甚至韩国生产的，就难说了。
所以，可能在等等，秋天的时候也未必有信得过得替代品。如果现在还能宅家避免风险暴露，就再观望一下，如果想要开始恢复生活了，就从了mRNA。 毕竟mRNA接种之后得短期和中期（6个月）得安全数据是好的。长期的安全性，比如3-5年以上的，不是所有人都有条件等，而且即使有也是一个概率问题。而且mRNA已被证实对多种变种有效，尤其对减少重症有效了。
个人观点，非喜勿喷。还请有专业知识的对以上答疑纠错。先谢谢了！