全球领先疫苗，39支疫苗进入3期实验，10月13日，德国法国放弃两款mRNA疫苗，转为研发新一代疫苗和加强剂。中国两款疫苗进入第三期试验。

[lindamy]

2 hr 57 min ago

Johnson & Johnson's single-dose vaccine enters phase 3 trials
From CNN's Lauren Mascarenhas

This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. Cheryl Gerber/Courtesy of Johnson & Johnson/AP

Johnson & Johnson’s Covid-19 vaccine candidate begins phase 3 trials in the United States on Wednesday. Trials for the single-dose vaccine, which uses a human adenovirus, will include up to 60,000 adult participants at nearly 215 sites in the US and internationally.

The vaccine candidate was developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson. Phase 3 trials will begin immediately, with the first participants receiving doses Wednesday, Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters Tuesday.

Initial findings from the vaccine’s phase 1/2 trials in the US and Belgium suggest the vaccine provokes an immune response and is safe enough to move into large-scale trials.

Phase 3 trials will examine the safety and effectiveness of a single dose against a placebo to prevent symptomatic Covid-19. The fact that the trial will examine the efficacy of a single dose of the vaccine, instead of two doses, should expedite results, said Stoffels.

Trials will run in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. Johnson & Johnson intends to run a separate phase 3 trial in collaboration with the UK government to examine the effectiveness of two doses

If the vaccine is proven safe and effective, Johnson & Johnson said it expects the first doses to be available for emergency use authorization from the US Food and Drug Administration by early 2021.

Where things stand: Moderna, Pfizer/BioNTech and AstraZeneca also have Covid-19 vaccine candidates in Phase 3 trials in the United States, although AstraZeneca’s trial is currently paused.

Johnson & Johnson’s phase 3 trial is being conducted in collaboration with Operation Warp Speed, the federal government’s coronavirus vaccine effort.

 

[向问天]

世卫首席科学家：中国新冠疫苗已被证明有效


世界卫生组织总干事谭德塞表示，结束新冠肺炎大流行和加速实现全球经济复苏的最快方式，是确保所有国家都有人能接种新冠疫苗；世卫组织首席科学家苏米娅·斯瓦米纳坦表示，中国的新冠疫苗研发项目非常活跃，并且一些疫苗在现阶段临床试验中已被证明有效。

在新冠肺炎例行新闻发布会上，世卫首席科学家斯瓦米纳坦表示，中国的一些新冠疫苗已在现阶段临床试验中被证明是有效的。中国的新冠疫苗研发项目非常活跃，已有数个候选疫苗处于临床试验领先（高级）阶段，世卫组织对中国的新冠疫苗很感兴趣，一直在密切关注，一些疫苗在现阶段临床试验中已被证明有效。

 

[向问天]

中国新冠疫苗两针600元 这价格在全球排第几
新闻来源: CC周刊 于2020-09-23

核心提要：

1. 国内两款新冠病毒灭活疫苗价格出炉，一针300元、两针600元。目前已有10万多名高危人群接种疫苗，无一例明显不良反应，无一人感染。

2. 有说法称美国的新冠疫苗将是免费的，这并不准确。8月份，美国辉瑞和合作伙伴BioNTech（德国）宣布，已经与美国政府达成预先购买协议。但政府买单的只是批发价，疫苗运输、储存、注射是否还有额外的价格都是未知数。

3. 需要指出，目前美英俄的疫苗，都不是灭活疫苗，是RNA疫苗和腺病毒疫苗，生产过程中不需要新冠病毒。而中国的灭活疫苗生产过程比较复杂，生产成本及维持生物安全性的成本都比其他疫苗高。

4. 鉴于中国目前对疫苗没有急迫的需求，解决疫苗价格问题除国家出手外，还可以“等”。目前可以让疫苗企业较灵活地商业定价，将疫苗以合理价格提供给更为急需的国际市场，而国内部分急需的人可以自费注射。

一针300元、两针600元，定价依据何在？

9月22日，香港《南华早报》消息称，中国两款灭活疫苗正在申请药监部门的有条件批准，一旦获得批准，疫苗最高定价为600元（88美元）。目前这两款灭活疫苗，都需要接种两针，每针的价格是300元。

国药集团的灭活疫苗，之前已紧急提供给一些国企的出国人员以及高危人群自愿使用，许多在海外工作的人员、外交以及一线医护人员进行了施打。目前已经接种了数十万人次，无一例明显不良反应，无一人感染；其中打完疫苗之后去海外高风险国家和地区的数万人，截至目前实现了零感染。

国药集团旗下两款疫苗，已于七月全部进入第三阶段试验，预计在12月底上市。其董事长刘敬桢曾透露，一针疫苗剂量是4微克，保护率100%，需要2针，价格应在1000块钱以内。2针不到1000元的说法引发了网络热议，因为这个价格超出了很多人的预期。曾有媒体以1000元的定价，算了目前十万紧急接种者的收入，已经是一个惊人的数字。

对于疫苗定价问题，国药集团中国生物技术股份有限公司副总裁杨汇川曾做了回应。他表示，在正式上市以前，这个产品尚没有定价，但会充分考虑它的可及性、安全性、有效性和人们的支付能力来确定其价格。

据悉，疫苗的最终定价并不掌握在疫苗研发公司手中，政府监管部门也会介入到定价中来。国务院联防联控机制科研攻关组疫苗研发专班工作组组长郑忠伟日前明确表态，新冠病毒疫苗属于公共卫生产品，只能以成本作为定价依据。疫苗价格不会受常规市场供需关系所左右，最终价格肯定比上述的说法低。

目前每针300元，两针600元，可能是国药集团综合成本以及民众可以接受的能力，给出的一个基本定价。但国药集团并没有透露定价的依据以及考量。

 

[向问天]

都想在第3期试验完成之前偷步。

 

[CastleCode]

本来加拿大应该是第一个试用的，结果一碗粥搅糊了，现在啥都没有了。

 

[枫国冰都]

说到底还是亚非拉信任中国呀。

 

[RareEarth]

如果重症率死亡率以后一直维持在很低水平，即便有了疫苗，我也绝对不会去打。

 

[PAL]

取决于你的年龄

 

[向问天]

社会平均死亡率，和某人感染后的死亡率，差别大过太平洋。

 

[CastleCode]

如果重症率死亡率以后一直维持在很低水平，即便有了疫苗，我也绝对不会去打。

死了倒好了，就怕不死终身留残疾，来个半死不活。

 

[RareEarth]

每年流感要死不少人，天上掉个陨石，打个雷，或者地震，都可能人让半死不活。
如果因此就生活在恐惧中，那还有啥好活的

死了倒好了，就怕不死终身留残疾，来个半死不活。

 

[CastleCode]

每年流感要死不少人，天上掉个陨石，打个雷，或者地震，都可能人让半死不活。
如果因此就生活在恐惧中，那还有啥好活的

这个比有意义吗？每年天上掉个陨石，打个雷能人让半死不活有几个。

 

[RareEarth]

身体健康的人有几个重症，死亡，留下后遗症的？
如果第二波疫情不比往年其他流行病的后果严重，那就不过是生活的常态，操心有意义吗。

这个比有意义吗？每年天上掉个陨石，打个雷能人让半死不活有几个。

 

[CastleCode]

身体健康的人有几个重症，死亡，留下后遗症的？
如果第二波疫情不比往年其他流行病的后果严重，那就不过是生活的常态，操心有意义吗。

又扯上身体健康了，如果大家身体都健康的话安省还花那么多钱建医院干嘛？是的身体暂时健康的人可能不用担心，可那些身体不健康的呢？ 看看那些老人。

 

[lindamy]

1 hr 5 min ago
Here's the latest on Johnson & Johnson's Covid-19 vaccine
From CNN’s Andrea Kane

This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. Cheryl Gerber/Courtesy of Johnson & Johnson/AP

Early results from a Phase 1/2a clinical trial of Johnson & Johnson’s coronavirus vaccine shows that it was well tolerated and even one dose appeared to produce a strong immune response in almost all of the participants for whom data is available.

The study was posted Friday on MedRxiv, a preprint server, which means that it has not yet been peer-reviewed or published in a medical journal.

This interim analysis of the Phase 1/2a trial looked at the safety and side effects of two different doses of the vaccine in almost 800 participants, including about 400 18- to 55-year-olds and about 400 people 65 and older.

The analysis also looked at the vaccine’s ability to produce an immune response in the 18- to 55-year-olds, plus a small subset of those in the 65 and older group, who are at much higher risk of getting very sick and dying from the virus.

The researchers found that 99% of the participants age 18 to 55 in both dose groups had developed antibodies against the virus 29 days after getting vaccinated. Among the participants 65 and older, only 15 had antibody data available and 100% were seropositive.

The analysis also found that most of the side effects were mild and resolved after a couple of days. The most common were fever, headache, fatigue, body aches and injection-site pain. The study authors note that the rate of side effects was lower in the older participants than in the younger ones — 36% compared to 64% — and this may mean that older people may not be having as strong an immune response.

Some of the participants from each age group and from both dose groups will receive a second shot of the vaccine as part of the trial, but the results published Friday are based on data after the first shot.

The vaccine – called Ad26.COV2.S – uses a non-replicating adenovirus to deliver the SARVS-CoV-2 spike protein; it’s the same technology used in J&J-developed vaccines for Ebola, Zika, HIV and RSV.

Based on the results of this study, Johnson & Johnson on Wednesday became the fourth company to begin large Phase 3 trials; the company says it plans to enroll 60,000 adult volunteers at more than 200 sites in the US and internationally.

So far it’s the only Phase 3 Covid-19 vaccine trial in the United States that is testing a single-dose of the vaccine.