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]

独家：巴西拟增购两千万剂中国科兴新冠疫苗--圣保罗州长​

2021年2月5日1:14 凌晨更新于10 小时前

路透新闻部 1 分钟阅读

路透圣保罗2月5日 - 圣保罗州长周四在接受路透采访时表示，巴西正在洽谈，准备额外购买中国科兴控股生物开发的2,000万剂新冠病毒疫苗。此举显示了其对于中国疫苗的信心。

2021年1月28日，巴西库里蒂巴，一名医务人员展示中国科兴的新冠疫苗。REUTERS/Rodolfo Buhrer

此前未有关于这笔订单的报导。州长Joao Doria表示，这将是此前订购的1亿剂科兴CoronaVac疫苗之外的新订单。圣保罗的布坦坦研究所(Butantan Institute)已经获得CoronaVac疫苗。

该国营机构在巴西领导了对该疫苗的大规模临床测试，目前正在为一项全国免疫计划分装疫苗，计划在2022年初实现100%在国内生产。另一种获准在巴西紧急使用的新冠疫苗是阿斯利康疫苗。

圣保罗是巴西最富有和人口最多的州，州长Joao Doria一直是CoronaVac疫苗在巴西进行测试和接种的幕后推手。此举有助于增强其竞选总统的信心，也加剧了他与巴西总统博尔索纳罗(Jair Bolsonaro)之间的矛盾。

但该款疫苗在巴西的实验中有效性仅略高于50%，远低于市场上其他的备选疫苗，部分人士因此质疑巴西是否应该采购其他疫苗；目前巴西是美国以外疫情最为严重的地方。

巴西卫生部与疫苗开发商洽谈采购合约时动作迟缓，对中国采批判态度、对新冠病毒存疑的博尔索纳罗虽然起初驳回科兴疫苗，但在缺乏替代品的情形下已经改变态度。

圣保罗州长表示，他预期布坦坦研究所将以每周或每10天的频率收到从中国寄送的疫苗活性成分，以克服初期可能拖慢生产的瓶颈。

布坦坦研究所一座兴建中工厂预定将自2022年1月起生产疫苗活性成分，进度落后于先前的目标今年下半年。布坦坦研究所正在协商取得额外供应2,000万剂疫苗，期能在新厂开始运作前维持最终目标不变。

目前为止，巴西卫生部只有和布坦坦研究所签订一份合约采购4,600万剂科兴疫苗供全国分配，但圣保罗州长称，他相信很快将再洽购5,400万剂。

“在攸关生死的情况下，我们不会坐等事态发展，”他说道。(完)

编译 张涛/张明钧;审校 李婷仪/刘秀红

Reuters | Breaking International News & Views

Find latest news from every corner of the globe at Reuters.com, your online source for breaking international news coverage.

cn.reuters.com

 

[lindamy]

辉瑞,莫多拿,阿斯瑞卡三大公司的疫苗比较（抗体滴度, 常规保护率，对突变体效果）​

来源: 杨别青 于 2021-02-05 19:30:43
辉瑞,莫多拿,阿斯瑞卡三大公司的疫苗目前已经获得紧急使用授权，美国CDC不主张未经试验的疫苗混用，即使辉瑞和莫多拿mRNA疫苗也有明显差别：
1. 临床试验使用不同的年龄组

辉瑞：16-65岁

莫多拿：18-65岁

阿斯瑞卡: 18-65岁

2. 剂量，成分，间隔不同

• 辉瑞(mRNA30 微克, 0.3 毫升): 两剂间隔21 天
• 莫多拿(mRNA100 微克, 0.5 毫升): 两剂间隔28 天
• 阿斯瑞卡：两剂间隔28 天, 病毒颗粒，5x1010

3. 抗体产生的滴度不同（生物学测试）

辉瑞：引发体液以及细胞免疫，是新冠愈后病人抗体的20倍。

阿斯瑞卡（AstraZeneca）：体液以及细胞免疫，是新冠愈后病人抗体的1.8- to 2.7倍。

4. 保护率(医学效果测试）

辉瑞：95%

莫多拿：94.5%

阿斯瑞卡: 半剂量90%（2,741人参试），全剂量（5x1010)60%（8,895人参试）

4. 对最新病毒突变体的保护效果（英国，南非，巴西三个主要病毒突变体）

“英国科学家初步研究发现，肆虐当地的“B.1.1.7”新冠变种病毒株变异幅度更为剧烈，令病毒传播能力较以往强70%。”未观察到致死率的差别。
南非，巴西突变体尚未有明确的结果。

辉瑞：预印论文称对英国突变体（B.1.1.7），体外抗体中和率下降2 倍，对南非突变体(B.1.351)，下降6.5倍。
辉瑞公司自称，对英国突变体保护率依然达到89.3%。

莫多拿公司自称, 对英国突变体保护率没有明显下降，但对南非突变体(B.1.351)，体外抗体中和率下降6倍。
阿斯瑞卡： 尚未有数据公布

我个人看法： 从接种后产生的抗体滴度来看，mRNA疫苗产生的抗体是阿斯瑞卡疫苗抗体的10倍，保护率mRNA疫苗高于阿斯瑞卡疫苗，因而认为mRNA疫苗优于阿斯瑞卡疫苗。

2月4日，英国科学家开始为期13个月的试验以检测混用阿斯瑞卡（病毒载体疫苗）和辉瑞疫苗(mRNA 疫苗 )的效果。
2-5-2021

Can you mix vaccines? UK trial aims to find out | CNN

UK scientists have launched the world's first study examining whether different coronavirus vaccines can safely be used for two-dose regimens, an approach they say could give extra flexibility and even boost protection against Covid-19 if approved.

www.cnn.com

Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC

Find interim clinical considerations for the use of COVID-19 vaccines for the prevention of coronavirus disease 2019 (COVID-19) in the United States.

www.cdc.gov

辉瑞,莫多拿,阿斯瑞卡等公司的疫苗比较（抗体滴度, 常规保护率，对突变体效果） - 杨别青发表于 健康养生 - 论坛 | 文学城

bbs.wenxuecity.com

 

[lindamy]

19 min ago

Peru becomes the first Latin American country to roll out the Chinese vaccine, Sinopharm​

From CNN’s Claudia Rebaza and Mitchell McCluskey

Peru began distributing China’s Sinopharm vaccine on Tuesday morning, with frontline health care workers taking priority during the first phase of the rollout.

The country has taken part in the Sinopharm vaccine’s clinical trials since last year and becomes the first Latin American country to roll out the Chinese vaccine.

A group of doctors at Lima’s Arzobispo Loayza Hospital were the first to receive the vaccine on Tuesday morning, state news agency Andina reported.

President Francisco Sagasti is expected to be vaccinated later on Tuesday.

On Sunday, Peru received its first shipment of 300,000 doses of China's Sinopharm coronavirus vaccine, and expects to receive the remaining 700,000 doses on February 14. The armed forces will be in charge of the vaccine’s distribution across the country.

On Monday, Foreign Affairs Minister, Elizabeth Astete, announced her government has reached an agreement with Pfizer for the supply of 20 million doses of their vaccine, state news agency Andina reported.

Astete told a Congress Committee that 250,000 doses will arrive in March and at least 300,000 in April, Andina reported.

"We were assured that Peru will have received a minimum of 5,750,000 vaccines by July 1, and the supply will increase significantly to 20 million since then," Astete said.

Astete also told lawmakers her government has signed an agreement to receive 6.6 million doses from Pfizer and AstraZeneca via the Covaxprogramme to vaccinate 20% of the population.

President Sagasti, who took office in November, has faced criticism for the delay in reaching a supply agreements for the vaccine.

Peru currently has 1,186,698 confirmed cases of coronavirus and has recorded 42,308 deaths, according to data from Johns Hopkins University (JHU).

The country has been reporting more than 6,000 cases a day, an increase over the 2,000 cases a day in early January, while it is also facing a shortage of intensive care unit (ICU) beds and oxygen during this new wave of the pandemic.

Peru has the fifth highest Covid-19 case count in Latin America, after Brazil, Colombia, Argentina and Mexico according to JHU data.

 

[lindamy]

是时候信任中国和俄罗斯的疫苗了​

ACHAL PRABHALA, CHEE YOKE LING2021年2月9日

去年12月初，医护人员在莫斯科一家诊所为一名医生接种俄罗斯的Sputnik V新冠疫苗。业界领先的医学杂志《柳叶刀》发表的试验结果显示，Sputnik V疫苗的有效率为91.6%。 SERGEY PONOMAREV FOR THE NEW YORK TIMES

世上最富裕的几个国家正在竭力应对Covid-19疫苗短缺的问题，与此同时，一些穷国则担心自己根本得不到疫苗。不过这两个问题的对策可能就在眼前：来自中国和俄罗斯的疫苗，也许很快还有印度。

中国和俄罗斯疫苗一开始受到了西方和其他国际媒体的排斥，因为他们觉得，这些疫苗跟莫德纳(Moderna)、辉瑞(Pfizer)-BioNtech或阿斯利康(AstraZeneca)的出品无法相提并论。这种印象似乎在一定程度上是因为中国和俄罗斯是专制国家。

但是我们早就已经看到这些疫苗在这些国家取得良好效果的证据。顶尖医学期刊《柳叶刀》(The Lancet)上周发表的末期试验中期结果显示，俄罗斯的疫苗Sputnik V有效率达到91.6%。这验证了疫苗开发者加马列亚中心(Gamaleya Center)和俄罗斯直接投资基金(Russian Direct Investment Fund)在去年12月中旬公布的发现。

阿联酋、巴林、埃及、约旦、伊拉克、塞尔维亚、摩洛哥、匈牙利和巴基斯坦已经批准了中国国药(Sinopharm)的疫苗；截至今年1月中旬，阿联酋已经有180万人接种了这种疫苗。玻利维亚、印度尼西亚、土耳其、巴西和智利已经批准并开始接种科兴(Sinovac)的另一种中国疫苗。Sputnik V将在欧洲、中东、非洲和拉美的十几个国家进行接种。

在审核这些疫苗时，这些国家做了周祥的考虑，他们以中国和俄罗斯生产厂家提供的安全和效力证据为基础，而那些证据有相当一部分也发表在了《柳叶刀》和《美国医学会杂志》(JAMA)等同行评审的科学期刊上——有的还进行了自己的独立试验。质疑这些决策，就是在质疑这些政府的能力或诚信，其中一些国家的卫生监管系统并不比美国或欧洲差。

面对严重的疫苗短缺和递送延误，法国、西班牙和德国也已经在考虑订购中国和俄罗斯的疫苗。看起来，情急之下，他们终于开始表示不要对非西方疫苗有“成见”了。

但疑心并没有散去。俄罗斯疫苗在伊朗、中国疫苗在巴基斯坦，以及两者在肯尼亚和南非，都遭到了质疑。YouGov近日对17个国家的19000人展开调查，向其询问对各国开发疫苗的“正面或负面”看法：俄罗斯、中国和印度排在末尾（只有伊朗除外）。

这在一定程度上是可以理解的。中国和俄罗斯出于自身的考虑进行宣传，大肆夸耀他们各自的疫苗，这只会让人愈发警惕，尤其是在国外。

中国和俄罗斯去年还在没有末期（或称三期）临床试验效力数据的情况下给部分国民接种。（辉瑞-BioNTech和莫德纳的疫苗是在得出三期试验中期分析结果后得到美国批准的。）印度近日也在用巴拉特生物科技(Bharat Biotech)开发的疫苗Covaxin做同样的事，引起了举国的愤怒。

这三个国家的政府都辩称，此举是加快疫苗生产和分配所须的紧急措施。这种解释对有些人来说可能是不够的，但这样做并不违法，西方的监管机构也会出于同样的原因走捷径（尽管会更透明一些）。

而现在已有重要数据能证明中俄疫苗的有效性。（要判断Covaxin疫苗有效性还为时过早。）去年12月初在阿联酋进行的试验结果显示，国药疫苗的有效性为86%；它在中国的试验有效性为79%。

需要说明的是，这些有效性数据衡量的标准究竟是什么，意义又是什么。对此的困惑引发了人们对疫苗的怀疑——尽管对某些疫苗的怀疑要多于其他疫苗。
以科兴疫苗为例，关于它的效果，似乎存在互相矛盾的结果：土耳其试验的有效性为91%，印度尼西亚为65%，巴西为50.4%。巴西的结果迅速登上国际新闻头条，尽管进行这些试验的国家研究中心——位于圣保罗的布坦坦研究所(Butantan Institute)的研究人员也指出，该疫苗在预防新冠轻症到重症方面的有效率为78%。

1月底，我们采访了布坦坦研究所的临床研究医学总监里卡多·帕拉西奥斯(Ricardo Palacios)，他告诉我们，这些试验被有意设计成了“压力测试”。他说，这些试验仅在“直接看护新冠病人的医务工作者”中进行。（辉瑞-BioNTech和莫德纳疫苗的试验对象包括一些医务工作者和其他高危人群，但并不仅限于他们。）而且，当研究对象是更容易受到感染的人群时，疫苗的效果可能就不是那么好了。布坦坦研究所的试验对于新冠症状的定义也比其他试验更广泛。

换句话说，即使是对同一种疫苗，试验方案也不尽相同。考虑到这一点，现在再想象一下不同疫苗试验结果之间可能存在的差异——它反映的可能不仅仅是疫苗的效果，还可能说明试验的设计。

一名中国医务工作者在北京接种新冠疫苗。对于“有效性”到底衡量什么、意味什么的困惑引发了人们对疫苗——以及一些疫苗是否比其他疫苗更有效的怀疑。 KEVIN FRAYER/GETTY IMAGES

毫无疑问，必须向公众公布更多关于中俄疫苗的信息，但西方领先的疫苗在某种程度上也应如此。并非所有辉瑞-BioNTech和莫德纳疫苗试验的细节或原始数据都被公开，甚至连研究人员都看不到。

事实是，新冠疫苗的研发或公布都没有达到应有的透明度。虽然中俄疫苗的推出可能比一些西方企业糟糕，但这并不一定意味着其疫苗是劣质的。

越来越多的证据表明，中俄的疫苗是可靠的，应得到严肃对待，而且特别考虑到全世界都出现的供应问题，还得尽快严肃对待。

大多数西方制造的疫苗已经被发达国家买光：根据呼吁在世界范围内更广泛和公平地获取疫苗的组织联盟“人民疫苗联盟”(People’s Vaccine Alliance)的数据显示，截至12月初，莫德纳的所有疫苗和96%的辉瑞-BioNTech疫苗都已卖完。

全球疫苗免疫联盟(Gavi)储存了部分西方疫苗。但根据我们对其供应数据的统计，截至本周，预计在今年第一季度，它只能发运1.1亿至1.22亿剂阿斯利康疫苗，辉瑞-BioNTech疫苗则只有120万剂——而这些疫苗要供应所有与全球疫苗免疫联盟签订了新冠疫苗协议的145个国家。

而且，西方多数大型药企都拒绝向非西方制造商授权其疫苗，一些发达国家正在阻止印度和南非的一项提议，即要世界贸易组织(World Trade Organization)暂时撤销对新冠相关疫苗和治疗方法的部分知识产权保护。

另一方面，根据分析公司Airfinity提供的最新数据分析，科兴已经签订了协议，今年将向12国出口3.5亿剂疫苗；国药疫苗则准备向11国出口1.94亿剂；
Sputnik V疫苗向17国出口约4亿剂。这三家制造商都公开表示，它们在2021年都有生产多达10亿剂疫苗的能力。三家公司也都已将疫苗授权给多个国家的本地制造商。

那么，如何才能使这些疫苗对更多需要它们的人具有吸引力呢？一种办法是让有专业技术知识的国际组织对它们进行正式评估。目前的问题是，世界卫生组织(World Health Organization)的疫苗认证规则本身就是偏向富裕的、基本都在西方的国家。

世卫组织有一份清单，上面列出了它在质量管控上信任的“严格监管机构”——除了澳大利亚、加拿大、日本和美国，其余都是欧洲国家。在世界其他地区，世卫组织采用一种被称为预认证的手续。在理论上，通过这种办法，中国或俄罗斯的疫苗可以获得与西方疫苗同等的权重。但在现实中，这是一个繁复且耗时的程序。

当在世卫组织信任名单上的国家研发并批准了一种疫苗，该组织通常会基于该评估将其迅速批准。但当其他国家的疫苗制造商申请预认证的时候，世卫组织要从头开始进行全面评估，包括对生产设施的实际检查。

在制造商提出申请不到两个月后，世卫组织于2020年底批准了辉瑞-BioNTech疫苗，并预计将在本月对莫德纳和阿斯利康疫苗做出决定。中俄疫苗仍在排队等待，尽管对它们的审查程序开始得更早。

在审查辉瑞-BioNTech疫苗的过程中，世卫组织与欧洲药品管理局（European Medicines Agency，简称EMA）进行了密切合作，在EMA批准疫苗的10天后也完成了批准。在维持标准的同时，世卫组织没有理由不能与其他国家的卫生监管机构合作，帮助当地疫苗制造商通过审批程序。它必须立即给予所有疫苗生产国应有的重视。

一些医生和活动人士已经提议，要在世界范围内增加西方生产的疫苗的供应。这些呼吁是善意的，但同样也认定只有西方国家的疫苗才值得拥有——以及等待。

眼下已经有了一个更简单的解决办法：是时候信任其他国家的疫苗了。


更正：由于翻译错误，本文中文版稍早时称国药疫苗似乎存在矛盾的结果，应为科兴疫苗。特此更正。

Achal Prabhala是AccessIBSA项目协调员，该项目为获得医药品进行活动，他也是Shuttleworth基金的一名研究员。Chee Yoke Ling是Third World Network执行理事，这个国际政策研究、权利促进组织总部位于马来西亚槟城。

翻译：纽约时报中文网

点击查看本文英文版。

是时候信任中国和俄罗斯的疫苗了

中俄疫苗最初受到西方排斥，似乎是因为这两国的专制体制，但已有证据证明它们同样有效。鉴于当下全球的供应问题，它们值得被严肃对待。

cn.nytimes.com

 

[向问天]

需要说明的是，这些有效性数据衡量的标准究竟是什么，意义又是什么。以科兴疫苗为例，关于它的效果，似乎存在互相矛盾的结果：土耳其试验的有效性为91%，印度尼西亚为65%，巴西为50.4%。巴西的结果迅速登上国际新闻头条，尽管进行这些试验的国家研究中心——位于圣保罗的布坦坦研究所(Butantan Institute)的研究人员也指出，该疫苗在

西方的报道真没有啥公正性。

 

[lindamy]

3 hr 47 min ago

Mexico grants emergency use approval for 2 China-made Covid-19 vaccines​

From CNN's Eric Cheung

A health worker shows the Sinovac vaccine at a community health centre in Lambaro, Indonesia on January 18. Chaideer Mahyuddin/AFP/Getty Images

Mexico has issued emergency use approval for China's CanSino and Sinovac coronavirus vaccines, the country's deputy health minister Hugo Lopez-Gatell announced Wednesday.

He said the approval was granted by Mexico's Federal Committee for Protection from Sanitary Risks (Cofepris) after it reviewed the vaccines' quality, safety and efficacy, according to a statement posted on the Health Ministry's website.

The first bulk shipment of the CanSino vaccine will arrive in Mexico from China on Thursday, where it will be packed at a plant in the central city of Queretaro, the statement said.

Mexico has also issued an emergency use authorization for Russia's Sputnik V coronavirus vaccine and ordered millions of doses.

At least 1,957,889 confirmed Covid-19 cases and 169,760 deaths have been reported in Mexico, according to Johns Hopkins University.

 

[lindamy]

5 min ago

Chile inoculates more than 1 million people, a week into its mass vaccination program​

From CNN's Eric Cheung

Seniors wait to be vaccinated with China's Sinovac Covid-19 vaccine at a vaccination center in Santiago, Chile, on February 3. Esteban Felix/AP

More than one million people have been inoculated in Chile since the country began its mass coronavirus vaccination program one week ago, Chilean President Sebastian Pinera tweeted Wednesday.

“Let’s make 2021 the year of hope,” the tweet said. “Together we will overcome this pandemic and regain the joy of living.”

Chile kicked off its mass vaccination campaign last Wednesday, and the government set a target to vaccinate 15 million by mid-year. The first doses of the vaccine arrived in the country in December and were given to medical workers from December 24.

In January, Chile issued an emergency-use authorization for China's Sinovac Covid-19 vaccine. The country has also been using the Pfizer/BioNTech vaccine for health officials and the elderly.

Chile's total population is close to 19 million, according to the World Bank. The country has reported at least 760,576 Covid-19 cases and 19,105 deaths, according to Johns Hopkins University.

 

[lindamy]

4 hr 45 min ago

CanSinoBio files application for Covid-19 vaccine approval as trials show 65% efficacy rate​

From CNN’s Beijing bureau
Chinese company CanSino Biologics said on Wednesday it has filed an application with China’s drug regulator for conditional approval of its Covid-19 vaccine. If approved, the company would become the nation’s third vaccine maker to provide shots for conditional public use in China.

CanSinoBio said that Phase 3 clinical trial results show that its coronavirus vaccine has an overall efficacy rate of 65.28% at preventing all symptomatic cases and 90.07% at preventing all severe cases 28 days after a single dose. More than 40,000 volunteers in five countries participated in the trial, the statement added.

Sinopharm, the first Covid-19 vaccine developer whose doses were approved for conditional public use in China, has an overall efficacy rate of 79.34%. Sinovac followed, with an overall efficacy rate varying from 50.4% in trials in Brazil to 91.25% in trials in Turkey.

 

[lindamy]

19 min ago

India's Covaxin Covid-19 vaccine 81% effective against coronavirus​

From CNN's Akanksha Sharma and Manveena Suri

A medic with COVID-19 vaccine during the Bharat Biotech's 'Covaxin' human trial after it was approved by the Indian Council of Medical Research, at Maharaja Agrasen Super Speciality Hospital in Jaipur, Rajasthan, India, Friday, December 18.( Photo by Vishal Bhatnagar/NurPhoto/Getty Images/FILE

India's Covaxin vaccine is 81% effective against coronavirus, according to early data released Wednesday by Bharat Biotech, the company that developed the drug jointly with the government-run Indian Council of Medical Research (ICMR).

The vaccine's clinical trial involved 25,800 participants between 18 and 98 years old. The efficacy figure is based on an early analysis of 43 Covid-19 cases. Thirty-six cases occurred in participants who got a placebo, compared to seven participants who got the vaccine.

Data indicates the vaccine can also effectively combat the coronavirus variant first spotted in the UK, according to an analysis by the National Institute of Virology, Bharat said in a news release.

“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus…Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr. Krishna Ella, the company's chairman and managing director.

Covaxin is a two-dose vaccine. It is the first Covid-19 vaccine that has been developed in its entirety in India. In March 2020, following the successful isolation of the novel coronavirus virus, the ICMR established a public-private partnership with Bharat Biotech to develop the virus isolate into a vaccine candidate.

Over 40 countries have expressed their interest in Covaxin, including Mongolia, Myanmar, Sri Lanka, the Philippines, Bahrain, Oman, Maldives and Mauritius.

 

[lindamy]

7 min ago

Cuba announces its vaccine candidate is authorized to begin Phase 3 trials​

From CNN’s Patrick Oppmann

A technician works with the Soberana 02 Covid-19 vaccine at the Finlay Vaccine Institute in Havana, Cuba, on January 20. Yamil Lage/Pool/AP

Cuban scientists announced that the island’s Soberana vaccine candidate had received authorization to begin phase three trials immediately.

A second vaccine Abdala would also begin phase three trials soon, scientists said.

While many developing countries have struggled to import vaccines, Cuba has focused on making their own as a way to raise money and instill national pride in the island’s bio-medical industry.

Two of the four Cuban vaccines candidates are named Soberana – Spanish for sovereignty. The remaining two are called Abdala, the name of a poem written by Cuban revolutionary icon Jose Marti, and Mambisa, referring to Cuban guerillas who fought a bloody war for freedom against the Spanish.

More than 85,000 Cubans would take part in the two final phases of the trials as the island’s state-run biomedical industry begins larger production of the vaccines. If approved for widescale use, Soberana and Abdala would be the first two vaccines developed in Latin America.

You can read more on Cuba’s vaccine trials here.

 

[lindamy]

New additions and recent updates
March 5 加拿大批准Johnson & Johnson 疫苗。	Canada authorizes Johnson & Johnson’s vaccine.
March 4	A vaccine from BioNet-Asia and Australia’s Technovalia enters Phase 1.
March 4 古巴疫苗在哈瓦那招募44,010志愿者参加第3期试验。	Cuba’s Soberana 2 vaccine moves to Phase 3.
March 1	Massachusetts-based VBI Vaccines enters Phase 1/2.
Feb. 27	The Food and Drug Administration authorizes Johnson & Johnson’s vaccine for emergency use.
Feb. 26	Canada authorizes the Oxford-AstraZeneca vaccine for emergency use.
Feb. 25	China approves two vaccines by CanSino and Sinopharm for general use.
Feb. 25	Bahrain authorizes Johnson & Johnson’s vaccine for emergency use.
Feb. 22	A vaccine developed by the Icahn School of Medicine enters Phase 1.
Feb. 22	Sanofi moves to Phase 2.
Feb. 20	Russia approves the Chumakov Center vaccine for early use.
Feb. 18	China’s Shenzhen Kangtai moves to Phase 2.
Feb. 16	A nasal spray from India’s Bharat Biotech enters Phase 1.
Feb. 10	A vaccine from Italy’s Takis and Rottapharm enters Phase 1.

PHASE 3

Cuba’s Finlay Vaccine Institute developed a vaccine known as Soberana 2. It contains a part of the coronavirus spike protein, fused to a standard tetanus vaccine to make it stable. Soberana 2 also contains aluminum hydroxide as an adjuvant to boost the immune system.

After testing Soberana 2 in animals, Finlay researchers started a Phase 1 trial in October, followed by a Phase 2 trial in December. In January Cuba reached an agreement with Iran to test their vaccines in a Phase 3 trial. On March 3, the Finlay Vaccine Institute registered a Phase 3 trial for Soberana 2, with plans to recruit 44,010 participants in Havana.

Cuba is planning to make 100 million doses of Soberana 2 in order to vaccinate its entire population. Cuba is pinning hopes on the vaccine as a source of economic benefit to the island.

Updated Feb. 18

 

[lindamy]

Novavax vaccine 96% effective against original coronavirus version in U.K. trial​

DANIA NADEEM AND CARL O'DONNELL
REUTERS
PUBLISHED 4 HOURS AGOUPDATED MARCH 11, 2021

Novavax Inc’s COVID-19 vaccine was 96% effective in preventing cases caused by the original version of the coronavirus in a late-stage trial conducted in the United Kingdom, the company said on Thursday, moving it a step closer to regulatory approval.

The vaccine was also about 86% effective in protecting against the more contagious virus variant first discovered and now prevalent in the UK.

It was only around 55% effective in a separate, smaller trial in South Africa, where volunteers were primarily exposed to another newer, more contagious variant that is widely circulating there and spreading around the world.

In both trials, the vaccine was 100% effective in preventing serious illness and death.

Results from the final analysis of the UK trial were largely in line with interim data released in January, which also showed the Novavax shot to be 96% effective against the original version of the coronavirus and around 86% effective against UK variant.

The company expects to use the data to submit for regulatory authorization in various countries. It is not clear when it will seek U.S. authorization or if regulators will require it to complete an ongoing trial in the United States.

Novavax vaccine 96% effective against original coronavirus version in U.K. trial

The vaccine was also about 86% effective in protecting against the more contagious virus variant first discovered and now prevalent in the UK

www.theglobeandmail.com

 

[lindamy]

3月11日，意大利的ReiThera 的非复制型病毒载体疫苗进入2/3期试验。

3月11日，美国Novavax 的蛋白重组疫苗三期试验显示很好的结果。

注：医学知识不多，名称翻译多参考google，不一定准确，见谅。

 

[lindamy]

今天中国批准安徽智飞生物公司和北京医学科学院的生物医学研究所的蛋白质亚基（不知翻译得是否正确，与Novavax属于同一类疫苗）疫苗的获得早期使用特批许可。

China approves another COVID-19 vaccine for emergency use​

By HUIZHONG WUan hour ago

FILE - In this Jan. 15, 2021, file photo, a medical worker gives a coronavirus vaccine shot to a patient at a vaccination facility in Beijing. China is aiming to vaccinate 70-80% of its population by mid-2022, the head of the country's Center for Disease Control said Saturday.(AP Photo/Mark Schiefelbein, File)
TAIPEI, Taiwan (AP) — China has approved a new COVID-19 vaccine for emergency use, one that was developed by the head of its Center for Disease Control, adding a fifth shot to its arsenal.

Gao Fu, the head of China’s CDC, led the development of a protein subunit vaccine that was approved by regulators last week for emergency use, the Chinese Academy of Sciences’ Institute of Microbiology said in a statement Monday.

It is the fifth coronavirus vaccine approved in China and the fourth to be given emergency use approval. Three of those given emergency approval have since been approved for general use. All were developed by Chinese companies.

The latest vaccine was developed jointly by Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. and the Chinese Academy of Sciences. The team finished phase 1 and phase 2 clinical trials in October and is currently conducting the last phase of trials in Uzbekistan, Pakistan and Indonesia, according to the statement.

The vaccine was approved for use in Uzbekistan on March 1. It’s a three-dose shot that is spaced out with one month each between shots, a company spokesperson said. Like other vaccines China has developed so far, it can be stored at normal refrigeration temperatures.

There is no publicly available information in peer-reviewed scientific journals about the clinical trial data showing efficacy or safety. A spokesperson for the company said that the data could not be shared at this time but that the company was providing the information to health authorities.

The protein subunit vaccine is similar to many of the other vaccines that have been approved globally in that it trains the body to recognize the spike protein that covers the surface of the coronavirus, although the difference lies in how it tells the body to recognize the protein. Scientists grow a harmless version of the protein in cells and then purify it, before it is assembled into a vaccine and injected.

China has been slow in vaccinating its population of 1.4 billion people, despite having four vaccines approved for general use. The latest numbers, according to government officials at a press briefing Monday in Beijing, is that it has administered 64.98 million doses of vaccines.

China has targeted what it considers key populations for vaccination thus far, namely health care workers, those who work at the border or customs, and specific industries the government has selected. Other groups that have been notably absent thus far in comparison to many other countries are the elderly and those with pre-existing conditions.

The approved vaccines have previously been limited to adults 18-59 years old, as officials cited a lack of clinical trial data for those who are older, although the government appears to be signaling the limits are now being set aside.

“We will promptly carry out mass vaccination of relevant populations,” Li Bin, a vice chair on the National Health Commission, said Monday.

China’s official Xinhua News Agency reported over the weekend that in certain neighborhoods in Beijing, local health centers started to offer the vaccines to those aged 60 and older.

China approves another COVID-19 vaccine for emergency use

TAIPEI, Taiwan (AP) — China has approved a new COVID-19 vaccine for emergency use, one that was developed by the head of its Center for Disease Control, adding a fifth shot to its arsenal.

apnews.com

 

[向问天]

意大利疫情反弹。