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]

June 22

Cuba reports that its Abdala vaccine has an efficacy of 92%.

PHASE 3

VACCINE NAME: Abdala
EFFICACY: 92.28%

In November 2020, the Center for Genetic Engineering and Biotechnology of Cuba launched a trial on a coronavirus vaccine called Abdala. The name is from a poem by the nineteenth-century poet José Marti. The Abdala vaccine consists of a piece of the coronavirus spike protein called the receptor binding domain, and is delivered in three doses. On Feb. 1, the center held a press conference to announce the start of a Phase 2 trial. A Phase 3 trial involving up to 48,000 participants was launched on March 18. On May 12, while the Phase 3 trial was still underway, the Cuban government began rolling out Abdala in a mass vaccination campaign, in the hopes of reining in a surge of cases. On June 21, Cuban officials reported that Abdala had an efficacy of 92.28 percent.

Updated June 22

 

[lindamy]

6月23日，土耳其灭活疫苗进入第三期试验。

PHASE 3

VACCINE NAME: Turkovac

On Nov. 5, Turkey’s Erciyes University announced they had begun injecting volunteers with an inactivated coronavirus vaccine called ERUCOV-VAC. It was the first clinical trial of a coronavirus vaccine developed in Turkey. On Dec. 14, the president of the university said that the Phase 1 trial was complete. Sabah Today reported the following month that Phase 2 trials had begun. On June 23, Turkish president Recep Tayyip Erdoğan announced that the vaccine, renamed Turkovac, has begun Phase 3 trials.

Updated June 24

New additions and recent updates

June 22 土耳其灭活疫苗进入第三期试验。	Turkey’s Erciyes University moves to Phase 3.
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 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.

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.

 

[lindamy]

全球领先疫苗，32支疫苗进入3期实验，7月9日，古巴紧急批准使用Abdala疫苗，7月20日，台湾紧急授权批准使用经二期试验的高端疫苗.​

New additions and recent updates
July 20 台湾紧急授权批准使用经二期试验的高端疫苗。	Taiwan authorizes Medigen’s Phase 2 vaccine for emergency use.
July 20	OSE Immunotherapeutics pauses its Phase 1 trial.
July 20	Russia’s St. Petersburg Scientific Research Institute enters Phase 1/2.
July 15	Turkey’s Middle East Technical and Bilkent University move to Phase 2.
July 9 古巴授权紧急使用Abdala疫苗	Cuba authorizes the Abdala vaccine for emergency use.

7月20日，台湾紧急授权批准使用经二期试验的高端疫苗。7月9日，古巴紧急授权

在抗原选择上，高端2019冠状病毒病疫苗取得美国国家卫生研究院（NIH）和德州大学奥斯汀分校授权，共同开发的S-2P棘蛋白原始生物材料、验证用抗体、以及技术平台[6][7][8][9]。在制程上采用CHO制程，使用带有S-2P棘蛋白基因的质体感染中国仓鼠卵巢细胞（ExpiCHO-S cells），进而纯化S-2P棘蛋白。佐剂则选择Dynavax公司的CpG 1018铝盐佐剂[10]。

该疫苗已在2021年6月10日完成第二期临床试验，[11]该多中心双盲性试验收了台湾 3158位20岁以上成人[12]，全球 3700 人[13][14][15]。显示具有99.9%的血清阳转率（SCR），在安全性上实验组耐受性及安全性表现良好，具有统计学上的显著性差异[16]。

PHASE 2 EMERGENCY USE IN TAIWAN

Taiwan-based vaccine maker Medigen is making a vaccine made of a combination of spike proteins and an adjuvant from Dynavax. After a series of promising experiments on animals, they began injecting volunteers for a Phase 1 trial in early October, which showed that the vaccine provoked strong immune responses. On Dec. 30, Medigen announced that it had received permission to commence a Phase 2 trial. The first volunteers in the trial were injected in late January 2021. In July, Medigen started another Phase 2 trial on children between 12 and 18 years old.

Taiwan granted emergency use authorization to the vaccine on July 19. In the announcement, the government said that volunteers in the Phase 2 trial were producing strong levels of antibodies. Medigen expects to produce 10 million doses in 2021 and will deliver the first vaccines for use in Taiwan in August.

EMERGENCY USE IN: Taiwan NEW.

Updated July 20

PHASE 3 EMERGENCY USE IN CUBA

VACCINE NAME: Abdala
EFFICACY: 92.28%

In November 2020, the Center for Genetic Engineering and Biotechnology of Cuba launched a trial on a coronavirus vaccine called Abdala. The name is from a poem by the nineteenth-century poet José Marti. The Abdala vaccine consists of a piece of the coronavirus spike protein called the receptor binding domain, and is delivered in three doses. On Feb. 1, the center held a press conference to announce the start of a Phase 2 trial. A Phase 3 trial involving up to 48,000 participants was launched on March 18. On May 12, while the Phase 3 trial was still underway, the Cuban government began rolling out Abdala in a mass vaccination campaign, in the hopes of reining in a surge of cases. Venezuela began using the vaccine in late June. On June 21, Cuban officials reported that Abdala had an efficacy of 92.28 percent. Cuban officials approved a trial for Abdala in young people on July 1. On July 9, the Cuban government granted emergency use authorization for the vaccine.

EMERGENCY USE IN: Cuba NEW.
Updated July 9

 

[光放]

如果这是老共作的事情，你们会怎么说？

 

[lindamy]

New additions and recent updates
Aug. 20 印度紧急批准世界第一款DNA疫苗	India authorizes Zydus Cadila’s DNA-based vaccine for emergency use.
Aug. 19	Spain’s HIPRA enters Phase 1/2.
Aug. 9 以色列疫苗进入2/3期试验	The Israel Institute for Biological Research moves to Phase 2/3.
Aug. 9	California-based City of Hope moves to Phase 2.
Aug. 9	China’s Shanghai Zerun and Walvax Biotechnology move to Phase 2.
Aug. 9	The University of Tübingen in Germany moves to Phase 2.
Aug. 9	South Korea’s Cellid moves to Phase 1/2.
Aug. 2	China’s Shanghai Zerun and Walvax Biotechnology enter Phase 1.
July 20	Taiwan authorizes Medigen’s Phase 2 vaccine for emergency use.
July 20	OSE Immunotherapeutics pauses its Phase 1 trial.
July 20	Russia’s St. Petersburg Scientific Research Institute enters Phase 1/2.
July 15	Turkey’s Middle East Technical and Bilkent University move to Phase 2.
July 9	Cuba authorizes the Abdala vaccine for emergency use.

印度批准世界首款DNA疫苗 称能对抗任何变种病毒​

文章来源: Newtalk 于 2021-08-21 12:28:37 - 新闻取自各大新闻媒体，新闻内容并不代表本网立场！

印度当局今天批准第2款国产疫苗ZyCoV-D紧急使用授权，并将首次开放给国内12岁以上孩童接种；此外，ZyCoV-D也是全球第一款CDNA疫苗。

印度生物科技局今天宣布批准印度药厂ZydusCadila的ZyCoV-D疫苗，表示这是“世界上首款且由印度本土研发的COVID-19（2019冠状病毒疾病）DNA疫苗”，并使用无针注射器施打。

与Zydus Cadila合作的印度生物科技局在声明中表示，ZyCoV-D为3剂式疫苗，注射后会使人体产生SARS-CoV-2棘蛋白，并诱发免疫反应，且这款DNA疫苗采用的技术可以轻松应对病毒突变，例如目前已发生的COVID-19变异。

英国广播公司（BBC）报导，ZyCoV-D关键的第3期临床试验是在印度第2波COVID-19疫情尖峰期实施，使疫苗制造厂Zydus Cadila坚信这款疫苗对变异株具有效力，特别是传染力极强的Delta变种病毒（最先发现于印度）。

半岛电视台（Al Jazeera）报导，ZyCoV-D疫苗含有一部分病毒遗传物质，注射后以DNA或RNA形式发出指令，使人体产生能激发免疫系统反应的特异性蛋白质。

ZyCoV-D成为第6款印度政府批准使用的COVID-19疫苗，批准疫苗中包含印度巴拉特生物技术公司（BharatBiotech）自制的Covaxin。

印度13亿人口中已有超过3200万例COVID-19确诊个案、43万3589人染疫病逝；全国各地过去几周疫苗接种率有所提升，目前已施打超过5亿7400万剂。

此外，印度当局希望在12月底前为所有符合接种条件的国民施打疫苗，但由于只有大约10%的人口完整接种两剂式疫苗，相当于1.27亿人，一些卫生专家表示，印度需进一步提高本土疫苗产量。

印度自产疫苗不需任何特殊储存设备，因此较易克服运输上的困难并送至全国各地供人民接种。

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PHASE 3 EMERGENCY USE IN INDIA

VACCINE NAME: ZyCoV-D
EFFICACY: 66.6%
DOSE: 3 doses, 4 weeks apart
TYPE: Skin injection
STORAGE: Stable at room temperature for three months

In July 2020, the Indian vaccine-maker Zydus Cadila began testing a DNA-based vaccine delivered by a skin patch. They launched a Phase 2 trial on ZyCoV-D on Aug. 6 and announced at the end of December that it was complete. On Jan. 3, 2021 the Indian government gave Zydus Cadila permission to advance to a Phase 3 trial with 30,000 volunteers.

The company announced on July 1 that the vaccine had an efficacy of 66.6% and that none of the vaccinated volunteers in the trial developed severe disease or died, making ZyCoV-D the first DNA-based vaccine shown to work against Covid-19. Zydus Cadila received emergency authorization from the Indian government on Aug. 20.

EMERGENCY USE IN: India NEW.
Updated Aug. 20

 

[lindamy]

New additions and recent updates
Sept. 3 加拿大mRNA 疫苗与印度达成协议，进入第二期试验	Canada’s Providence Therapeutics moves to Phase 2.
Aug. 30 中国珠海丽珠医药和中科院生物物理研究所的蛋白疫苗进入第三期试验	China’s Institute of Biophysics and Livzon begin a Phase 3 trial.
Aug. 24	Bavarian Nordic moves to Phase 2.
Aug. 23	The Pfizer-BioNTech vaccine receives full F.D.A. approval.
Aug. 20	Cuba authorizes Soberana 2 and Soberana Plus for emergency use.
Aug. 20	India authorizes Zydus Cadila’s DNA-based vaccine for emergency use.
Aug. 19	Spain’s HIPRA enters Phase 1/2.

中国丽珠医药蛋白疫苗进入第三期试验，加拿大mRNA疫苗进入第二期试验。

PHASE 2

Canada’s Providence Therapeutics specializes in messenger RNA vaccines to treat cancer. In response to the pandemic, they developed an mRNA vaccine against the coronavirus. They launched a Phase 1 study of an RNA vaccine in late January 2021, and in May announced that the vaccine appeared safe and produced promising levels of antibodies. In August, Providence Therapeutics launched a Phase 2 trial.

In June, the company reached an agreement with the Indian vaccine maker Biological E to carry out further trials in India. Biological E agreed to purchase up to 30 million doses and planned to scale their production of the vaccine to as many as a billion doses in 2022.

google 翻译：

加拿大的Providence Therapeutics专门研究用于治疗癌症的信使RNA疫苗。 为了应对大流行，他们开发了一种针对冠状病毒的 mRNA 疫苗。 他们于 2021 年 1 月下旬启动了一项 RNA 疫苗的第一阶段研究，并于 5 月宣布该疫苗似乎是安全的，并产生了有希望的抗体水平。 8 月，Providence Therapeutics 启动了第二阶段试验。

今年 6 月，该公司与印度疫苗制造商 Biological E 达成协议，将在印度进行进一步的试验。 Biological E 同意购买多达 3000 万剂疫苗，并计划在 2022 年将其疫苗生产规模扩大到多达 10 亿剂。

Updated Sept. 3

PHASE 3

A subsidiary of Chinese company Livzon Pharmaceutical Group has developed a protein vaccine in collaboration with the Institute of Biophysics at the Chinese Academy of Sciences. Called V-01, the vaccine completed Phase 1 and 2 trials earlier in 2021. A Phase 3 trial began in the Philippines on Aug. 25.

Updated Aug. 30

 

[lindamy]

不明白加拿大研发的疫苗要去印度生产。加拿大生产Moderna 还有希望吗？

 

[lindamy]

New additions and recent updates
Sept. 22 进入2/3 期联合试验阶段	A nasal spray vaccine by Washington University and Bharat Biotech moves to Phase 2/3.
Sept. 22	A vaccine developed at the Icahn School of Medicine at Mount Sinai moves to Phase 2.
Sept. 22 三叶草公司宣布对住院保护率为100%。	Clover Biopharmaceuticals announces vaccine efficacy results against the Delta variant.
Sept. 22	New York-based Codagenix announces promising Phase 1 results.
Sept. 21	Britain’s Scancell enters Phase 1.
Sept. 20	Pfizer says a smaller dose of the vaccine is safe and effective for children ages 5 to 11.
Sept. 17	Iran’s Razi Vaccine and Serum Research Institute moves to Phase 3.
Sept. 13	Australia’s EnGeneIC enters Phase 1.
Sept. 13	Russia’s BIOCAD enters Phase 1/2.

华盛顿大学的研究人员设计了一种鼻腔喷雾疫苗，印度制药商 Bharat Biotech 获得了该技术的许可，9 月 21 日，Bharat 董事长宣布，9月22日开始进行2/3 期试验。

9 月 22 日，三叶草公司发布试验结果表明，他们的疫苗对于 Delta 变体的有效性为 79%，住院率的保护有效性为 100%。

PHASE 2 PHASE 3 COMBINED PHASES

Clover Biopharmaceuticals developed a vaccine containing the spike protein from coronaviruses. To further stimulate the immune system, the company combined the proteins with so-called adjuvants made by British drugmaker GSK and the American company Dynavax. Clover’s formulation looks to be especially durable; the vaccine can sit out at room temperature for a month and remain viable. Investments from the Coalition for Epidemic Preparedness supported the development of manufacturing that could lead to the production of a billion doses a year. On June 30, 2021, Clover announced an agreement to provide 400 million doses to COVAX, the initiative to deliver vaccines to low- and middle-income countries.

Clover launched a Phase 1 trial in June 2020, , and in December the company announced that the vaccine triggered a high level of antibodies. It registered a Phase 2/3 trial with the GSK adjuvant, but in February 2021 the company announced it was cancelling the study. Instead, it has moved forward with a trial with the Dynavax adjuvant. On Sept. 22, Clover announced that the trial showed their vaccine has an efficacy of 79 percent against disease from Delta variant, and a 100 percent efficacy against hospitalization.

Updated Sept. 22

PHASE 2 PHASE 3 COMBINED PHASES

Researchers at Washington University designed a nasal spray vaccine that can produce high levels of coronavirus antibodies in mice with just a single dose. It contains a chimpanzee adenovirus engineered to carry the spike protein gene. The Indian drug maker Bharat Biotech licensed the technology, and in February 2021 they won approval to launch a Phase 1 trial of a vaccine, which they named BBV154. On Sept. 21, the chairman of Bharat announced that the Phase 2/3 trial was set to begin in a matter of days. Government officials announced on Aug. 11 that they will allow Bharat to perform a trial that mixes BBV154 with Covaxin.

Updated Sept. 22

 

[lindamy]

截止10月13日为止，全世界共有39款疫苗进入3期或者2/3期联合试验阶段。

德国和法国放弃两款mRNA 疫苗；

1. 德国的CureVac于去年12月已经进入3期试验，今年6月三期试验仅达到48%的防感染率，对于18-60岁志愿者效果稍好，达到53%，住院和死亡的保护率达到100%。三期试验结果虽然不理想，这款疫苗仍然在欧盟申请用于60岁以下人群的紧急批准，但未获欧盟加速审理，今天这款疫苗撤出申请，宣布放弃。

CureVac 现在正在致力于英国的GSK合作研发新一代新冠疫苗。

2. 9月28日，法国Sanofi 和美国Translate Bio 合作的mRNA 疫苗，今年3月进行了1/2期试验，因为辉瑞和莫德纳疫苗已经广泛使用，Sannofi 宣布放弃这款疫苗。

Sanofi 现在正在致力于一款作为加强剂的protein - based 疫苗的三期试验。

3. 中国两款疫苗进入第三期试验。

4. 伊朗紧急授权批准澳大利亚Spikogen疫苗。

5. 韩国Genexine 的DNA疫苗于10月在印尼开始2/3期联合试验。

New additions and recent updates
Oct. 13 香港大学和厦门大学鼻喷型疫苗9月22日进入3期试验。	The University of Hong Kong and Xiamen University move to Phase 3.
Oct. 13 中逸安科生物、辽宁茂康源生物和军事医学科学院联合研发的疫苗9月5日进入第三期试验	China’s Zhongyianke Biotech moves to Phase 3.
Oct. 12 伊朗紧急授权批准并生产澳大利亚Vaxine的Spikogen 疫苗，8月13日开始第三期试验，结果将于年底公布。	Iran authorizes Spikogen, a vaccine by the Australian company Vaxine.
Oct. 12 德国放弃第三期试验未达标的mRNA 疫苗	Germany’s CureVac abandons its Phase 3 vaccine, CVnCoV.
Oct. 7 韩国Genexine 的DNA疫苗于10月在印尼开始2/3期联合试验	South Korea’s Genexine moves to Phase 2/3.
Oct. 7	The San Francisco company Vaxart moves to Phase 2.
Oct. 6	Norway’s Vaccibody enters Phase 1/2.
Sept. 30	Korea’s Eyegene enters Phase 1/2.
Sept. 28 法国Sanofi 放弃今年3月进入1/2期试验的mRNA疫苗	France’s Sanofi abandons its mRNA Covid-19 vaccine program.
Sept. 22 美国FDA 授权为 65 岁及以上的人群和其他高危人群接种第三针辉瑞 BioNTech 疫苗。	The F.D.A. authorizes a third shot of the Pfizer-BioNTech vaccine for people age 65 and older, and other populations at high risk.
Sept. 22 华盛顿大学和 印度Bharat Biotech 的鼻喷雾疫苗进入第 2/3 阶段。	A nasal spray vaccine by Washington University and Bharat Biotech moves to Phase 2/3.
Sept. 22	A vaccine developed at the Icahn School of Medicine at Mount Sinai moves to Phase 2.
Sept. 22	Clover Biopharmaceuticals announces vaccine efficacy results against the Delta variant.

PHASE 3

In 2019, researchers at the University of Hong Kong and Xiamen University created a nasal-spray vaccine for the flu based on a genetically weakened form of the influenza virus. In early 2020, they engineered the vaccine to produce part of the coronavirus spike protein as well. On Sept. 9, they received approval to start clinical trials in partnership with Beijing Wantai Biological Pharmacy. They registered a Phase 1 trial on March 22, 2021. At a June 11 press conference, a researcher for the Chinese Center for Disease Control and Prevention said that this vaccine has completed Phase 2 trials. And on Sept. 22, the researchers registered a Phase 3 trial. The researchers are receiving $5.4 million in support from CEPI, the Coalition for Epidemic Preparedness Innovations.
Updated Oct. 13

PHASE 3

Researchers at Zhongyianke Biotech, Liaoning Maokangyuan Biotech and the Academy of Military Medical Sciences are using Chinese hamster ovary cells to help create immunity in humans. They registered a Phase 1 trial in China last November. On March 24, they advanced the vaccine to Phase 2. The researchers registered a Phase 3 trial on Sept. 5.
Updated Oct. 13

PHASE 3 EMERGENCY USE IN IRAN

The Australian company Vaxine developed a vaccine that combines viral proteins with an adjuvant that stimulates the immune system. A Phase 1 trial began in June 2020, and the company announced promising results in April 2021. In June, 2021, Vaxine launched a Phase 2 trial in Iran, followed by a Phase 3 trial, registered Aug. 13. In October, Iran issued an emergency authorization for Spikogen, to be produced by the Iranian company CinnaGen. Results of the Phase 3 trial are expected by the end of the year.

EMERGENCY USE IN: Iran.
Updated Oct. 12

ABANDONED

VACCINE NAME: CVnCoV
EFFICACY: 48%
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: Stable at least 3 months at 36–46°F (2–8°C)

The German company CureVac generated a lot of hope for its mRNA vaccine for Covid-19 in 2020, only to see it deliver disappointing results in clinical trials the following year.

The company, founded in 2001, had years of experience developing experimental mRNA vaccines for a host of diseases. In early 2020, they began work on a Covid-19 vaccine, called CVnCoV. In March, the Trump administration unsuccessfully tried to entice CureVac to move its research on their mRNA vaccine from Germany to the United States.

The company plowed ahead with its work in Germany, seeing responses to the vaccine in mice and monkeys before launching clinical trials in July. CVnCoV showed promise in several respects: it could remain stable in a refrigerator rather than a freezer, and preliminary studies suggested it would work well at a low dose, reducing its cost.

In December, CureVac launched a Phase 3 trial, recruiting up to 36,500 volunteers in Germany. The European Union began a rolling review in February, intended to speed up approval if the Phase 3 trial delivers positive results.

Meanwhile, CureVac prepared for mass production of the vaccine. The company negotiated a deal to provide the European Union with up to 400 million doses of their vaccine. They projected manufacturing up to 300 million doses in 2021 and up to a billion doses the following year. Starting in January 2021, CureVac forged a series of partnerships with pharmaceutical giants Bayer, Celonic, GSK, and Novartis, to support the production of their vaccine and develop new ones against coronavirus variants.

In June 2021, CureVac reported disappointing results from their Phase 3 trial. Overall, CVnCoV had an efficacy of just 48 percent against Covid-19. It proved somewhat better for younger volunteers: For those between the ages of 18 and 60, the efficacy rose to 53 percent. In that group, the researchers also found the vaccine provided 100 percent protection against hospitalization and death. Researchers later pointed to the vaccine dosage along with the rise of new variants as potential reasons for the low efficacy. On Sept. 14, CureVac announced that it had cancelled its manufacturing deals with Celonic and German company Wacker, citing a decline in demand for CVnCoV.

Despite the disappointing results, the company moved ahead with preparing an application to the European Union for emergency authorization for the use of the vaccine in people 60 and under. But European regulators gave no indication they would continue speeding along their review. As a result, on Oct. 12, CureVac announced that it would withdraw CVnCoV from the regulatory approval process.

Instead, CureVac is focusing its efforts on a next-generation vaccine for Covid-19, called CV2CoV, that it is developing with GSK. In an experiment on monkeys, researchers found that it generates a stronger immune response in animals compared to the original CVnCoV vaccine. In October 2021, CureVac indicated that it planned to start a Phase 1 trial on CV2CoV by the end of the year.
Updated Oct. 13

PHASE 2 PHASE 3 COMBINED PHASES

The South Korean company Genexine started testing the safety of a DNA-based vaccine in June 2020. In December, the Korea Biomedical Review reported that Genexine got disappointing results from their initial formulation and decided to restart their trials with a modified vaccine. On Jan. 20, 2021, the company registered a Phase 1/2 trial, and in June they registered a Phase 1 trial for elderly volunteers.

The Indonesian pharmaceutical company Kalbe Farma pledged in April to buy 10 million doses of Genexine’s vaccine if it is proven to be safe and effective. In July, Indonesian regulators gave the green light for a late-stage clinical trial. Genexine registered a Phase 2/3 clinical trial in October to test their vaccine as a booster for other vaccines.
Updated Oct. 7

ABANDONED

The French pharmaceutical company Sanofi collaborated with Massachusetts-based Translate Bio to develop an mRNA vaccine for Covid-19. In 2020, they reported that the vaccine, MRT5500, produced a strong antibody response in mice and monkeys, and protected hamsters against coronavirus infections. They followed up on that research with a Phase 1/2 trial in March 2021. Over the summer, Sanofi acquired Translate Bio for $3 billion. On Sept. 28, the company announced that the trial had yielded encouraging results. By then, however, Pfizer-BioNTech and Moderna vaccines were widely available, and so Sanofi decided to pull the plug on its own mRNA Covid-19 vaccine program. Meanwhile, it is continuing a Phase 3 trial on a protein-based vaccine that could serve as a booster against Covid-19.
Updated Sept. 28

 

[lindamy]

日本灭活疫苗今年3月开始1//2期临床试验，10月22日开始2/3期复合试验。该公司还参加了阿斯利康疫苗的生产。

PHASE 2 PHASE 3 COMBINED PHASES

On March 22, 2021, Japan’s KM Biologics announced that it had begun a Phase 1/2 trial of its inactivated vaccine candidate, called KD-414. The company has also played a part in manufacturing AstraZeneca’s vaccine. KM Biologics registered a Phase 2/3 trial in Japan for its vaccine on Oct. 22.

Updated Dec. 3

 

[lindamy]

2 hr 23 min ago

Plant-based Covid-19 vaccine shows high efficacy against Delta variant, says manufacturer​

From CNN’s Maggie Fo

An employee works on a production line at a GlaxoSmithKline factory in northern France, where adjuvant -- or the immune system booster -- for Covid-19 vaccines is manufactured. (Francois Lo Presti/AFP/Getty Images)

Medicago -- a company that has used a close relative of the tobacco plant to make vaccines -- said a Phase 3 trial of its Covid-19 vaccine showed it has 75% efficacy against symptoms of any severity caused by the Delta variant of the virus.

The company said no serious adverse events were seen in its trial in 24,000 volunteers in Canada, the United States, United Kingdom, Mexico, Argentina and Brazil.

It said it would apply for regulatory approval with Canadian authorities and start the processes for US and European authorization.

The company said the overall vaccine efficacy rate against all variants of the virus was 71%, adding:
"The vaccine candidate demonstrated efficacy of 75.3% against COVID-19 of any severity for the globally dominant Delta variant. Efficacy was 88.6% against the Gamma variant."

Reactions to the vaccine were generally mild and transient, the company said. It said it would publish the findings in a peer-reviewed journal.

The company uses a close relative of the tobacco plant, called Nicotiana benthamiana, to produce what are known as virus-like particles. These are non-infectious facsimiles of the virus, designed to prime the immune system to recognize a real virus if it infects someone.

The vaccine uses an adjuvant -- an immune system booster -- made by GlaxoSmithKline.

“If approved, we will be contributing to the world’s fight against the COVID-19 pandemic with the world’s first plant-based vaccine for use in humans,” Takashi Nagao, CEO and president of Medicago, said in a statement. Mitsubishi Tanabe Pharma Corporation is the parent company of Medicago.