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]

辉瑞疫苗递交申请扩大使用范围到2-11岁儿童。

辉瑞申请授权疫苗可以贮存于普通冰箱。

1 hr 15 min ago

Pfizer expects to submit for Covid-19 vaccine emergency authorization for kids ages 2 to 11 in September​

From CNN's Naomi Thomas

Pfizer expects to submit for US Food and Drug Administration emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 in September, the company said during its first quarter earnings teleconference on Tuesday.

The pediatric safety and efficacy study in children ages 6 months to 11 years old is ongoing.

Pfizer CEO Albert Bourla said in prepared remarks, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.

Phase 2 safety data from Pfizer’s ongoing study in pregnant women is expected by late July or early August, Bourla said.

Bourla also said the company expects to hear back shortly on its application for extended EUA for the vaccine to include 12-to-15-year-olds. On Monday, a federal government official said the FDA is poised to authorize the Pfizer coronavirus vaccine for that age group by early next week.

32 min ago

Pfizer seeking authorization for Covid-19 vaccine to be stored at standard refrigerator temperatures​

From CNN's Virginia Langmaid

Vials of the Pfizer-BioNTech Covid-19 vaccine at Kanto Rosai Hospital in Kanagawa Prefecture, Japan, on March 4. Kiyoshi Ota/Bloomberg/Getty Images

Pfizer has submitted information to the US Food and Drug Administration that may allow its Covid-19 vaccine to be stored at standard refrigerator temperatures, the company’s CEO said Tuesday. Such a change could help simplify distribution of the vaccine.

Pfizer CEO Albert Bourla said in an earnings meeting on Tuesday the company submitted new data to the FDA on Friday, and it may “soon” have an emergency use authorization to allow standard refrigeration for up to four weeks.
Currently, Pfizer’s vaccine is authorized to be stored at ultra-cold temperatures, between -80 and -60 degrees Celsius, or in cold storage, between -25 and -15 degrees Celsius, for a maximum of two weeks, which can complicate distribution of the vaccine.

According to Bourla, new data could allow the vaccine to be stored at standard temperatures, between 2 and 8 degrees Celsius, for up to four weeks.

Bourla said Pfizer is working on additional formulations that could further extend the storage time of the vaccine in both standard and ultra-cold refrigerators.

 

[lindamy]

WHO对MODERNA，国药和科兴疫苗评估的总结报告。

Moderna:

https://cdn.who.int/media/docs/defa...9_moderna_revised_final.pdf?sfvrsn=61ab4400_8

国药：

https://cdn.who.int/media/docs/defa...sage29apr2021_critical-evidence_sinopharm.pdf

科兴：

https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/5_sage29apr2021_critical-evidence_sinovac.pdf?

 

[lindamy]

38 min ago

Biden will announce today US will share millions more doses of Covid-19 vaccines globally​

From CNN's Kaitlan Collins

Filled vials wait to be distributed ahead of a Covid-19 vaccine clinic on May 13 in Houston. Brandon Bell/Getty Images

In his White House remarks in the next hour, President Biden is set to announce Monday that his administration will share millions more doses of Covid-19 vaccines with other countries in addition to the 60 million doses of the AstraZeneca vaccine he has already committed to sharing by July 4, according to an administration official.

Biden will say the US will share at least 20 million doses of Covid-19 vaccines by the end of next month, totaling 80 million doses that are set to be sent abroad.

Those additional 20 million doses will consist of Moderna, Pfizer and Johnson & Johnson vaccines as well as AstraZeneca, which has to be approved by federal regulators before being shipped overseas. That effort is underway.

Biden will also say White House Covid-19 response coordinator Jeff Zients is in charge of this effort, in coordination with the National Security Council and State Department.

Bloomberg was first to report the news of the additional doses being shared.

 

[茶马盐铁]

38 min ago

Biden will announce today US will share millions more doses of Covid-19 vaccines globally​

From CNN's Kaitlan Collins

Filled vials wait to be distributed ahead of a Covid-19 vaccine clinic on May 13 in Houston. Brandon Bell/Getty Images

In his White House remarks in the next hour, President Biden is set to announce Monday that his administration will share millions more doses of Covid-19 vaccines with other countries in addition to the 60 million doses of the AstraZeneca vaccine he has already committed to sharing by July 4, according to an administration official.

Biden will say the US will share at least 20 million doses of Covid-19 vaccines by the end of next month, totaling 80 million doses that are set to be sent abroad.

Those additional 20 million doses will consist of Moderna, Pfizer and Johnson & Johnson vaccines as well as AstraZeneca, which has to be approved by federal regulators before being shipped overseas. That effort is underway.

Biden will also say White House Covid-19 response coordinator Jeff Zients is in charge of this effort, in coordination with the National Security Council and State Department.

Bloomberg was first to report the news of the additional doses being shared.

靠， 这是帝国主义亡我之心不死啊！！

 

[lindamy]

全球领先疫苗，27支疫苗进入3期实验，8支完全批准，7支早期或有限批准。5月18日中国批准深圳康泰灭活疫苗紧急使用。​

New additions and recent updates
May 18	China authorizes Shenzhen Kangtai’s vaccine for emergency use.
May 14	France’s OSE Immunotherapeutics enters Phase 1.
May 10	The F.D.A. authorizes the Pfizer-BioNTech vaccine for children 12 to 15.
May 7	The W.H.O. gives emergency use authorization to the Sinopharm vaccine.
May 6	Russia authorizes a one-dose version of the Gamaleya vaccine, dubbed “Sputnik Light.”
May 5	China’s Lanzhou Institute of Biological Products enters Phase 1/2.
May 3	Denmark announces it will no longer use Johnson & Johnson’s vaccine.
May 1	Baltimore-based Elixirgen Therapeutics enters Phase 1/2.
April 30	Turkey’s Scientific and Technological Research Council of Turkey enters Phase 1.
April 28	A third vaccine from China’s Sinopharm enters Phase 1/2.
April 28	Kazakhstan begins public use of its QazVac vaccine.
April 26	A vaccine from Baylor College of Medicine and Texas Children’s Hospital moves to Phase 3.
April 23	The European Commission is preparing a legal case against AstraZeneca for failing to deliver enough doses.

 

[lindamy]

全球领先疫苗，27支疫苗进入3期实验，8支完全批准，7支早期或有限批准。5月18日中国批准深圳康泰灭活疫苗紧急使用。​

浏览附件976293

New additions and recent updates
May 18	China authorizes Shenzhen Kangtai’s vaccine for emergency use.
May 14	France’s OSE Immunotherapeutics enters Phase 1.
May 10	The F.D.A. authorizes the Pfizer-BioNTech vaccine for children 12 to 15.
May 7	The W.H.O. gives emergency use authorization to the Sinopharm vaccine.
May 6	Russia authorizes a one-dose version of the Gamaleya vaccine, dubbed “Sputnik Light.”
May 5	China’s Lanzhou Institute of Biological Products enters Phase 1/2.
May 3	Denmark announces it will no longer use Johnson & Johnson’s vaccine.
May 1	Baltimore-based Elixirgen Therapeutics enters Phase 1/2.
April 30	Turkey’s Scientific and Technological Research Council of Turkey enters Phase 1.
April 28	A third vaccine from China’s Sinopharm enters Phase 1/2.
April 28	Kazakhstan begins public use of its QazVac vaccine.
April 26	A vaccine from Baylor College of Medicine and Texas Children’s Hospital moves to Phase 3.
April 23	The European Commission is preparing a legal case against AstraZeneca for failing to deliver enough doses.

只是说要做临床试验，但是我找了很久也没有找到报道的实验数据。
而且这个是只有安徽批准使用，跟国内了解了一下，安徽几个城市都用这个，而其他几个省都没有用。
个人觉得疫苗审批应该国家说了算，

今天中国特批了深圳的康泰灭活疫苗，不知道三期数据是不是发表过，别以后又忘了啊。

Coronavirus Vaccine Tracker (Published 2022)

A look at all the vaccines that have reached trials in humans.

www.nytimes.com

 

[lindamy]

Chinese researchers at Stemirna Therapeutics have developed an mRNA vaccine in collaboration with Shanghai East Hospital. They registered a Phase 1 trial on May 1.

中国上海斯微生物与同济大学附属东方医院联合研发的mRNA疫苗5月1日进入1期试验。

关于我们​

斯微生物首次将mRNA药物及高端纳米制剂平台带入中国，并不断探索创新，努力成为亚洲乃至全世界的mRNA药物领导者，为全世界的患者提供更加有效的健康和治疗产品。

我们相信mRNA药物是一个具有巨大潜力的治疗平台，可以为癌症、传染病、罕见病等疾病带来更加快捷和有效的治疗方式。斯微生物的两大核心技术平台是我们后期开发mRNA药物的基础，更是我们全面领先的优势。

斯微生物于2016年在上海张江成立，由美国MD Anderson肿瘤中心的博士团队归国创建，现坐落于上海金桥自由贸易区。

斯微生物于2016年由美国的海归博士团队在上海张江药谷创建， 致力于打造中国领先的mRNA药物平台和产品管线。

2016年5月​

斯微生物在张江成立

2017年7月​

休斯顿卫理会医院授予斯微生物在LPP递送平台的全球独家商业化权益

2017年9月​

获得近2000万天使轮投资

2018年5月​

建成mRNA生产中心并开始产品管线研发

2018年9月​

mRNA合成平台验证、纳米制剂产业化生产验证

2018年11月​

第一位肿瘤患者给药

2019年4月​

获得近亿元A轮投资

 

[lindamy]

 

[lindamy]

Sanofi and GlaxoSmithKline 今天宣布招募3万5千，18岁以上人参加3期试验。

25 min ago

Sanofi and GlaxoSmithKline begin Phase 3 trial for coronavirus vaccine​

From CNN's Jacqueline Howard

The companies Sanofi and GlaxoSmithKline announced on Thursday that they have started enrolling volunteers in their Phase 3 clinical trial to assess the safety and efficacy of their coronavirus vaccine.

The trial will include more than 35,000 participants aged 18 and older from around the world, including the United States, Asia, Africa and Latin America, according to statements from the companies.

"We are encouraged to see first vaccinations starting to take place in such an important, pivotal Phase 3 study, as we believe that our unique technology platform will provide a clinically-relevant vaccine option," Thomas Triomphe, executive vice president and global Head of Sanofi Pasteur, said in the statement.

"We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting," Triomphe said. "This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic."

The companies announced that they plan to evaluate the efficacy of their vaccine against variants and test boosters. The release noted that, pending positive Phase 3 trial results, the vaccine could be authorized as early as in the fourth quarter of this year if all goes well.

"We believe further solutions for COVID-19 are very much needed to help reach people around the world, especially as the pandemic evolves and variants continue to emerge," Roger Connor, President of GSK Vaccines, said in the statement.

 

[lindamy]

5月28日，法国的Sanofi and 英国的GSK合作的mRNA疫苗进入3期试验。

去年Samofi的一款昆虫细胞生长的病毒蛋白疫苗曾经被预期良好，是美国预定的6大疫苗之一，花费21亿美元，预定了一亿剂，加拿大也预定了7200剂（足够每人打两针了）。但是由于12月开始的3期试验，对50岁以下人群的效果令人满意，对老年人效果不够理想，公司停止了试验。1月开始帮助德国的BNT生产了一亿疫苗，2月与强生公司达成了类似的协议。

同时，Samofi也在继续开发自己的疫苗，2月开始2期试验，疫苗诱发出强大的免疫反应，昨天进入3期试验。

New additions and recent updates
May 28	A vaccine from the French company Sanofi moves to Phase 3.

PHASE 3

In addition to their mRNA vaccine, Sanofi developed a Covid-19 vaccine based on viral proteins in early 2020. They produced the proteins with engineered viruses that grow inside insect cells. GSK supplemented these proteins with adjuvants that stimulate the immune system. The vaccine is based on the same design Sanofi used to create Flublok, an approved vaccine for influenza. The companies launched a Phase 1/2 clinical trial in September 2020.

Sanofi’s vaccine was widely expected to play a major role in tackling the pandemic. In the United States, Operation Warp Speed selected it as one of six vaccines to secure in large quantities, reaching a $2.1 billion agreement for 100 million doses. On Sept. 18 Sanofi closed another deal with the European Union for 300 million doses for an unspecified amount, and later reached an agreement with Canada for up to 72 million doses. In addition, Sanofi agreed to provide 200 million doses to COVAX, an international collaboration to deliver the vaccine equitably across the world. The company expected to move to a Phase 3 trial in December and potentially seek emergency use authorization in the United States by spring. Sanofi announced plans to make up to one billion doses in 2021.

But on Dec. 11, Sanofi and GSK announced that their vaccine was proving disappointing. While it provided promising levels of antibodies in people under 50, older people did not respond as strongly as they had hoped. The company halted the trial. In January Sanofi decided to help Pfizer and BioNTech make 100 million doses of their vaccine, and they reached a similar agreement with Johnson & Johnson in February.

Meanwhile, Sanofi developed a stronger formulation of their own vaccine. On Feb. 22, the company launched a new Phase 2 trial, which showed that the new version produced strong immune responses. They began enrolling participants for their Phase 3 trial on May 27, with hopes of authorization for their vaccine by the end of 2021.

Updated May 28

 

[m234]

浏览附件977721

把中国给省去了

 

[lindamy]

New additions and recent updates
June 1 四川华西医院研发的疫苗6月1日进入第三期试验，利用昆虫细胞进行。。。（不太懂属于哪种技术路线）。	The West China Hospital of Sichuan University moves to Phase 3.
June 1 中国第一款mRNA疫苗由中国军事科学医学院，苏州艾博生物科技有限公司（公司主页上除了招聘信息，完全是空白）和沃森生物有限公司联合研发。在墨西哥完成2期试验，6月1日将开始3期试验。	China’s Academy of Military Medical Sciences moves to Phase 3.
May 28 法国的Sanofi and 英国的GSK合作的mRNA疫苗进入3期试验	A vaccine from the French company Sanofi moves to Phase 3.
May 25	Pennsylvania-based VaxForm enters Phase 1.
May 20	China’s Stemirna Therapeutics enters Phase 1.
May 18 5月18日中国批准深圳康泰灭活疫苗紧急使用。	China authorizes Shenzhen Kangtai’s vaccine for emergency use.
May 14	France’s OSE Immunotherapeutics enters Phase 1.

PHASE 3

Last July, researchers at West China Hospital of Sichuan University published a study in Nature describing a vaccine made from the RBD region of the spike protein that could protect mice and monkeys from the coronavirus. To make the vaccine, researchers encoded the RBD region in a gene, which they inserted into a virus. They then infected insect cells with the virus, causing them to make the molecule in huge amounts. On Aug. 24, they launched a Phase 1 trial, and on Nov. 16 they moved to Phase 2 with a study on 960 volunteers. On Jan. 22, 20201, the researchers registered another Phase 2 trial with 4,000 volunteers. A Phase 3 trial began on June 1.

四川华西医院研发的疫苗6月1日进入第三期试验，利用昆虫细胞进行。。。（不太懂属于哪种技术路线）。


PHASE 3

In June 2020, Chinese researchers at the Academy of Military Medical Sciences, Suzhou Abogen Biosciences and Walvax Biotechnology announced they would start their country’s first safety trials on an mRNA-based vaccine, called ARCoV. Earlier studies on monkeys reportedly showed protective effects, and in the Phase 1 trial indicated it was safe in people. On Dec. 21, Xinhua reported that China was building a factory to produce 120 million doses per year.

Researchers launched a Phase 2 trial for the vaccine in January 2021, and registered a Phase 3 trial in April. The Global Times reported that the trial would likely be run in Latin America.

中国第一款mRNA疫苗由中国军事科学医学院，苏州艾博生物科技有限公司（公司主页上除了招聘信息，完全是空白）和沃森生物有限公司联合研发。在墨西哥完成2期试验，6月1日将开始3期试验。

Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine​

Reuters

Boxes of Walvax

Mexico to start late-stage clinical trial for China's mRNA COVID-19 vaccine

Mexico plans to start a late-stage clinical trial this month for a COVID-19 vaccine candidate developed by China using similar technology to shots from Moderna (MRNA.O) and Pfizer (PFE.N), foreign minister Marcelo Ebrard said on Tuesday.

www.reuters.com

 

[Sundown]

中国的病毒株跟欧洲的和美国加拿大的不一样。疫苗很可能不能通用。
中国的疫苗美国用不上。急死他们的事在后面。

灭活疫苗早就杜绝进入西方发达国家了

 

[Sundown]

中国康希诺的疫苗已经在中国完成了一期和二期临床试验。六月份出二期评估报告。因为中国现在的病例很少，三期临床试验可能要和加拿大合作。一旦试验成功，我们就和中国同步取得疫苗。
估计cfc上有些人肯定是拒用中国疫苗的。有毒

向xx应该会打️中国疫苗

 

[lindamy]

New additions and recent updates
June 14 Novavax公布试验结果，总体有效率90.4%。	Novavax announces trial results, with an overall efficacy of 90.4%.
June 14 伊朗批准 Shafa Pharmed Pars 疫苗用于紧急用途。	Iran authorizes the Shafa Pharmed Pars vaccine for emergency use.
June 14 越南 Nanogen 灭活疫苗进入第三阶段。	Vietnam’s Nanogen moves to Phase 3.
June 14 香港大学和厦门大学进入二期。	The University of Hong Kong and Xiamen University move to Phase 2.
June 8 西雅图的 Icosavax 进入第 1/2 阶段。	Seattle-based Icosavax enters Phase 1/2.
June 8 澳大利亚的 Vaxine 进入第二阶段。	Australia’s Vaxine moves to Phase 2.

美国马里兰州Novavax 的蛋白亚基（不知准确的中文对应名称）发布非常好三期试验数据。

2021 年 3 月 11 日，Novavax 报告说，他们在英国的试验确定对原始冠状病毒的有效率为 96%，对 Alpha 的有效率为 86%。但在南非，志愿者接触了 Beta 变体，疗效仅为 49%。该公司正在开发一种针对该变体量身定制的新版本疫苗。

同时，Novavax 继续扩大其疫苗的试验。 2021 年 5 月，该公司扩大了其在美国的第 3 阶段试验，包括 12 岁的志愿者。

计划在 2021 年第三季度在美国提交紧急使用授权申请。

PHASE 3

VACCINE NAME: NVX-CoV2373
EFFICACY: 90.4%
DOSE: 2 doses, 3 weeks apart
TYPE: Muscle injection
STORAGE: Stable in refrigerator

Maryland-based Novavax makes vaccines by sticking proteins onto microscopic particles. They were the first company to release Phase 3 trials showing that a protein-based vaccine provides strong protection against Covid-19. In a study on nearly 30,000 volunteers in the United States in Mexico, they estimated the vaccine’s efficacy at 90.4 percent. When Novavax released the first results from the trial on June 14, they said they were planning on submitting an application for emergency use authorization in the United States in the third quarter of 2021.

Before the pandemic, Novavax developed a number of vaccines for diseases based on their nanoparticle technology. In 2019, their flu vaccine finished Phase 3 clinical trials, but they had yet to deliver a single vaccine to market. In May 2020, the company launched trials for a Covid-19 vaccine in May 2020, and the Coalition for Epidemic Preparedness Innovations invested $384 million to support research on the vaccine. In July the U.S. government awarded Novavax another $1.6 billion to support the vaccine’s clinical trials and manufacturing.

After 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.

On March 11, 2021, Novavax reported that their United Kingdom trial determined an efficacy rate of 96 percent against the original coronavirus, and an efficacy of 86 percent against Alpha. But in South Africa, where volunteers were exposed to the Beta variant, the efficacy was only 49 percent. The company is developing a new version of the vaccine that is tailored to that variant.

Novavax reached an agreement in September 2020 with the Serum Institute of India, a major vaccine manufacturer, that could enable them to produce as many as 2 billion doses a year. They have an agreement with other countries, including the United Kingdom, Canada, Australia and South Korea. On Feb. 18, 2021, Novavax announced it would supply 1.1 billion doses to COVAX, a consortium that seeks to distribute vaccines to all countries across the world.

Yet Novavax has been dogged by delays in manufacturing and testing the quality of their vaccines. The company said it would not be authorized in the United States or Britain until at least July, and that it would not reach peak production until the end of the year.

Meanwhile, Novavax has continued to expand trials of its vaccine. In May 2021, the company expanded its U.S. Phase 3 trial to include volunteers as young as 12. Novavax’s vaccine is one of several being tested in an Oxford study that gauges how well alternating doses can increase immunity. It’s also part of another United Kingdom trial to assess the effectiveness of vaccines as boosters.

For more details, see How the Novavax Vaccine Works.
Updated June 14

伊朗灭活疫苗4月25日-6月14日进行三期试验，昨天，6月14日，获得伊朗政府紧急批准。

第三期试验有些参加者只接种了一针。

PHASE 3 EMERGENCY USE IN IRAN

Shafa Pharmed Pars, an Iranian pharmaceutical company, developed a vaccine made of inactivated coronaviruses. Results from preclinical trials showed that the vaccine was safe and effective in animals. Known as COVIran Barekat, it entered a Phase 1 trial at the end of December, becoming the first vaccine developed in Iran to go into clinical testing. CovIran Barekat began a Phase 3 trial on April 25, and on June 14, the Iranian government announced it had authorized the vaccine, despite the fact that many volunteers in the Phase 3 trial had not yet received their second dose.

EMERGENCY USE IN: Iran.

Updated June 14

越南蛋白亚基疫苗进入第三期试验。

PHASE 3

On Dec. 10, Nanogen Biopharmaceutical in Vietnam began recruiting 60 volunteers for a Phase 1 trial of their protein-based vaccine Nanocovax. Vietnam news agencies announced that Nanocovax entered a Phase 2 trial in February. In June, Nanogen launched a Phase 3 trial.

Updated June 14