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CNBC今天的报道：Dr. Paul Offit, a member of the FDA’s advisory committee, said data based on mice studies is not sufficient to justify authorizing the new boosters.

blueskygg(Grass)

It is the first time the FDA has authorized an updated vaccine formula since the shots rolled out in December 2020.

Full Story:
https://www.cnbc.com/2022/08/31/fda-authorizes-covid-booster-shots-that-target-omicron-bapoint5-variant-.html#:~:text=Dr.%20Paul%20Offit%2C%20a%20member%20of%20the%20FDA%E2%80%99s%20advisory%20committee%2C%20said%20data%20based%20on%20mice%20studies%20is%20not%20sufficient%20to%20justify%20authorizing%20the%20new%20boosters.

(#14783737@0)
Last Updated: 2022-8-31
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枫下家园 / 医药保健 / 看到有个谣言，说哪个狗头医生没看过新的疫苗的人体实验，只知道8只小白鼠。这个所谓的“医生”估计不是眼睛瞎了，就是心黑了。 -moonhalf(石室矢); 2022-8-31 {65} (#14783451@0)
FDA批准已经写得很清楚了多少人做了临床实验。这些造谣的真让人恶心。
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

Never Trust FDA from Now ON! Never Trust CDC Anymore! -111111(快乐老家); 2022-8-31 (#14783458@0) +6
鉴于你英语只读半句话的水平，会不会你又理解错了？呵呵。 -lovedrive(深蓝爷爷); 2022-8-31 (#14783538@0) +9

说说你的理解是什么，科普一下 -**🦋; 2022-8-31 (#14783546@0)

柳叶刀结论：“虽然接种疫苗可以降低感染风险，但是依然可以在家庭环境里有效传播并感染完全接种者”。楼主告诉我：这句话只用看前半句，说明疫苗有效防止病毒传染。每当楼主情绪激动时：笑死，气死之类，经常是英文理解错误，呵呵。 -lovedrive(深蓝爷爷); 2022-8-31 {79} (#14783565@0) +8
笑死，论文开头就写着疫苗可以有效防止delta病毒传染 -moonhalf(石室矢); 8-30 18:08

每当你笑的时候，肯定英文看错了。 -moonhalf(石室矢); 2022-8-31 (#14783928@0)

FDA说得很清楚了，BA.1做过人体实验，BA.4和BA.5没有做过人体试验，多家媒体都报道过了。 -blueskygg(Grass); 2022-8-31 (#14783609@0) +6

The only data we've seen for the BA.5 booster so far is in mice. 楼主的理解能力让我们深感忧虑呀。 -lovedrive(深蓝爷爷); 2022-8-31 (#14783649@0) +9

CNBC今天的报道：Dr. Paul Offit, a member of the FDA’s advisory committee, said data based on mice studies is not sufficient to justify authorizing the new boosters. -blueskygg(Grass); 2022-8-31 {1128} (#14783737@0) +5

It is the first time the FDA has authorized an updated vaccine formula since the shots rolled out in December 2020.

Full Story:
https://www.cnbc.com/2022/08/31/fda-authorizes-covid-booster-shots-that-target-omicron-bapoint5-variant-.html#:~:text=Dr.%20Paul%20Offit%2C%20a%20member%20of%20the%20FDA%E2%80%99s%20advisory%20committee%2C%20said%20data%20based%20on%20mice%20studies%20is%20not%20sufficient%20to%20justify%20authorizing%20the%20new%20boosters.

BA4/BA5早就是主流病毒了，最近的各国高峰都是这个变种，却没有数据，匪夷所思，可能是实验数据不好，无效。和孕妇数据一个套路。 -lovedrive(深蓝爷爷); 2022-8-31 (#14783790@0) +4

只有动物（老鼠）实验的数据。"Omicron Boosters Are Coming, But They Weren’t Tested on People. Here’s What You Need to Know" -xiyu66(lake); 2022-8-31 {766} (#14783918@0) +6
The FDA is considering whether to authorize the first Omicron-specific booster shots, based on animal data
Full Story:
https://time.com/6208623/omicron-boosters-animals-clinical-trials/

FDA批准的Moderna, Pfizer-BioNTech Bivalent COVID-19 都是有人体实验的。 -moonhalf(石室矢); 2022-8-31 {693} (#14783935@0)

The FDA authorized bivalent formulations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for use as a single booster dose.

Full Story:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

which evaluated a booster dose of Moderna’s investigational bivalent COVID-19 vaccine (original and omicron BA.1)不要胡搅蛮缠了，FDA原文，BA1和原始毒株。 -lovedrive(深蓝爷爷); 2022-8-31 (#14783951@0) +2

你这不“呵呵”英语也不行啊：The bivalent vaccines, -moonhalf(石室矢); 2022-8-31 {259} (#14783961@0)
which we will also refer to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

原文：the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1.哈哈哈。 -lovedrive(深蓝爷爷); 2022-8-31 (#14783981@0) +3
很多媒体都报道了，新疫苗没经过人体试验，你是看不懂，还是装不懂？ -blueskygg(Grass); 2022-8-31 (#14784383@0) +2

FDA批准的Moderna, Pfizer-BioNTech Bivalent COVID-19 都是有人体实验的。你是看不懂，还是装不懂？ -moonhalf(石室矢); 2022-8-31 (#14784734@0)

FDA网页都说了没有人体试验，各大媒体也报道了没有人体试验，你居然还能颠倒黑白，你这才能不做总理可惜了。 -blueskygg(Grass); 2022-8-31 (#14784750@0) +1

楼主别激动! 疫苗有效, 但是副作用也挺吓人的. -98765432(人情炼达); 2022-8-31 (#14783945@0) +1

没脾气了，楼主白纸黑字还能耍赖，厉害！ -lovedrive(深蓝爷爷); 2022-8-31 (#14783991@0) +5

莫德纳原株疫苗中的活性成分高达100 微克，辉瑞仅有30 微克。现在Moderna、辉瑞-BioNTech二价 COVID-19 疫苗的活性成分分别是多少啊？ -sunrain88(反求諸己); 2022-8-31 (#14784053@0) +1

不关心了。 -wonder99(Wonder); 2022-8-31 (#14784752@0)

楼主的文章中把变种mRNA疫苗与，流感变种毒株疫苗作类比，是不是每年的流感疫苗是不用做人体临床实验的？但mRNA与疫苗与流感疫苗不是同一技术，对于所含活性成分还是要注意的，毕竟活性成分高引发严重副作用的可能性更大 -sunrain88(反求諸己); 2022-8-31 {523} (#14784889@0) +1
The FDA has been planning for the possibility that the composition of the COVID-19 vaccines would need to be modified to address circulating variants. We sought input from our outside experts on the inclusion of an omicron component in COVID-19 boosters to provide better protection against COVID-19. We have worked closely with the vaccine manufacturers to ensure the development of these updated boosters was done safely and efficiently. The FDA has extensive experience with strain changes for annual influenza vaccines.

莫德纳50微克，辉瑞30微克。 -blueskygg(Grass); 2022-9-4 (#14791591@0)

6月30日美国食品药品监督管理局（FDA）疫苗部门负责人称，疫苗厂商应针对奥密克戎亚型变异株BA.4和BA.5进行研发，对于重新开发的疫苗，FDA在批准授权时，将不会要求公司提交新的人体临床试验数据，而会依赖于针对早期奥密克戎变异株BA.1疫苗的有效性研究。 -sunrain88(反求諸己); 2022-8-31 {414} (#14784855@0) +2
到底针对Omicron有几个新疫苗啊？？？今天批的这个是啥……
美国食品药品监督管理局(FDA)8月31日宣布，批准莫德纳和辉瑞-BioNTech二价新冠疫苗的紧急使用。FDA将允许在个人在首次接种新冠疫苗、或者接种加强针两个月后接种上述两款疫苗。本次获得紧急使用授权的二价新冠疫苗针对的是原始毒株和奥密克戎BA.4和BA.5变异株。
莫德纳的二价新冠疫苗被授权用于18岁及以上人群。辉瑞-BioNTech的二价疫苗被授权用于12岁及以上人群。
https://m.yicai.com/news/101462071.html

这是fda 大胆的决议，让我们耐心等待吧。拨乱反正需要时间，好在时间是个好东西，验证了人心，见证了人性，懂得了真的，明白了假的。 -wonder99(Wonder); 2022-8-31 (#14784931@0)

现在更需要安全性研究，刺突蛋白是否有毒造成炎症和血栓，会不会出现逆转路，会不会通过脑血屏障、胎盘屏蔽，刺突蛋白在体内代谢的时间以及会不会在某些器官沉积，比如卵巢影响卵子质量等问题。 -sunrain88(反求諸己); 2022-9-1 {218} (#14785146@0) +2
有效性的研究已没啥意义了，几周几个月，还是几倍几十倍，大家都知道不能防止传染，甚至不能防重症防死亡。
如果等同流感疫苗对待，那就不应该出现任何强制与限制，打与不打不影响任何人的正常生活、学习与行为活动。

正解。BA.1是做了人体实验的 -moonhalf(石室矢); 2022-8-31 (#14785046@0)

FDA8月31日批准的二价疫苗仅是BA.1的，含不含有BA.4, BA.5，我们普通人怎么区分？？但为什么又说本次获得紧急使用授权的二价新冠疫苗针对的是原始毒株和奥密克戎BA.4和BA.5变异株？ -sunrain88(反求諸己); 2022-9-1 (#14785151@0) +1

BA1做了人体试验，FDA没有批准上市，批准上市的是BA4BA5，这个没做过人体试验。 -blueskygg(Grass); 2022-9-1 (#14785220@0) +2

明白了批准上市的含BA.4BA.5的二价疫苗，只有如FDA文件最后一页所示N=8🐁的实验数据。 -sunrain88(反求諸己); 2022-9-1 {406} (#14785304@0) +1
实验报告是含BA.1的二价疫苗N=132人一个月后的数据？？
退一万步即便BA.4, BA.5如FDA预测的一样有效，信任疫苗在秋季想接种二价疫苗的还是考虑下mRNA疫苗的安全性再做决定吧……
:
https://www.fda.gov/media/159496/download

On August 31, 2022, the U.S. Food and Drug Administration authorized emergency use of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 😈 -sunrain88(反求諸己); 2022-9-2 {535} (#14788299@0)
Each single booster dose for ages 18 years and older is 0.5 mL
莫徳纳官网中没有标明含量
COVID-19 bivalent vaccine, mRNA-Moderna (Investigational)
Brand and Other Names:mRNA-1273.222
Dosage Forms & Strengths
- 50mcg/0.5mL (multiple dose 2.5mL vial)
- Each 0.5mL contains 25 mcg of original (wild-type spike protein) plus 25 mcg of omicron BA.4/BA.5 subvariants spike protein
https://reference.medscape.com/drug/covid-19-bivalent-vaccine-mrna-moderna-4000319#0
https://eua.modernatx.com/covid19vaccine-eua/Dear_HCP_Booster.pdf

@San Francisco

CNBC今天的报道：Dr. Paul Offit, a member of the FDA’s advisory committee, said data based on mice studies is not sufficient to justify authorizing the new boosters.

Replies, comments and Discussions:

COVID-19 bivalent vaccine, mRNA-Moderna (Investigational)

Dosage Forms & Strengths

More Topics