Clinical human trials begin for COVID-19 vaccine in China

[JSCh]

China's first Covid-19 therapeutic antibody drug approved for clinical trial
2020-06-07 9:18:02 GMT+8 | cnTechPost

(Photo: Unsplash)

Recently, Yan Jinghua's team at the Institute of Microbiology, Chinese Academy of Sciences, developed a new fully humanized monoclonal antibody against coronavirus, which was approved for clinical trials, according to the Beijing Daily.

The Phase I clinical trial will conduct dose exploration and safety validation in healthy humans.

This is the first therapeutic antibody approved for clinical trials of a novel coronavirus pneumonia drug in China, and the first in the world to be tested in a healthy population after completing non-human primate studies.

Yan Jinghua's team isolated and identified dozens of fully human antibody genes from patients who had been discharged from hospital after being cured of novel coronavirus pneumonia, and after repeated tests, they selected two strains of antibodies with high efficiency in neutralizing novel coronavirus activity in late February.

The results showed that the neutralizing antibodies effectively blocked the infection of the novel coronavirus, significantly reduced the load of novel coronavirus in the respiratory tract of rhesus monkeys, and protected the lung damage caused by the virus infection.

The results of animal experiments provide a positive prospect for the further development of therapeutic antibody drugs against novel coronavirus pneumonia.

(Yan Jinghua's team. Photo from China Science Daily.)

Source

 

[JSCh]

Cell journal publishes China's COVID-19 vaccine breakthrough
Source:Globaltimes.cn Published: 2020/6/9 4:12:30

Photo: Xinhua

China has developed an inactivated SARS-CoV-2 vaccine candidate, BBIBP-CorV. Related research and development of the COVID-19 inactivated vaccine was published by "Cell" on Saturday, one of the world's most respected life science academic journals.

Top scientists from the National Vaccine & Serum Institutes, Chinese Center for Disease Control and Prevention, Chinese Academy of Medical Sciences published their research paper, "Development of an inactivated vaccine Candidate, BBIBp-CorV, with potent protection against SARS- COV-2" to introduce their research on a COVID-19 vaccine in China to the world.

Gao Fu, director of the Chinese Center for Disease Control and Prevention, is one of the authors.

According to the research paper, they reported the pilot-scale production of an inactivated SARS-CoV-2 vaccine candidate, BBIBP-CorV that induced high levels of neutralizing antibodies titers in mice, rats, guinea pigs, rabbits and nonhuman primates (cynomolgus monkeys and rhesus macaques) to provide protection against SARS-CoV-2.

Two-dose immunizations using 2 μg/dose of BBIBP-CorV protected against SARS-CoV-2 intratracheal challenges in rhesus macaques, without detectable antibody-dependent enhancement of infection.

In addition, BBIBP-CorV exhibited productivity and strong genetic stability for vaccine manufacturing. The results support earlier evaluations of BBIBP-CorV during clinical trials, according to the paper.

The Beijing Vaccine & Serum Institute completed the construction of the world's largest inactivated COVID-19 vaccine production facility capable of manufacturing over 3 million doses, with an annual output of 100-120 million doses after mass production, the Xinhua News Agency reported.

In addition, the report also mentioned that the inactivated vaccine facility developed by the Wuhan Institute of Biological Products is slated for completion within the next month. By then, China's two biological research institutes will have an annual capacity of more than 200 million doses to ensure the accessibility of the inactivated COVID-19 vaccine.

 

[JSCh]

Sinovac Announces Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19

• Date: 2020-06-13

中文稿（Chinese Version）：科兴中维新型冠状病毒灭活疫苗I/Ⅱ期临床研究揭盲，初步结果显示该疫苗具有良好的安全性和免疫原性

Beijing-June 13, 2020 — Sinovac Biotech Ltd. ( “Sinovac” or the “ Company”)(Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles.

The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials. Of those, 143 volunteers are in phase I and 600 volunteers are in phase II. There have been no severe adverse event reported in either the phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce positive immune response.

The Company expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (announced on June 11, 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study. The Company expects to share the full data on our clinical trials with the public through academic publications.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “Our phase I/II study shows CoronaVac is safe and can induce immune response. Concluding our phase I/II clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19. We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19. Like with our other vaccines, we are committed to developing CoronaVac for global use as part of our mission of supplying vaccines to eliminate human diseases.”

As announced previously, Sinovac’s development of a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China. The Company received approval from China’s NMPA on April 13 to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China.


Sinovac Announces Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19-SINOVAC - SINOVAC

 

[JSCh]

https://www.facebook.com/video.php?v=151499283126274

 

[JSCh]

​

Structure-based Design of Antiviral Drug Candidates Targets SARS-CoV-2 Main Protease
Editor: LIU Jia | Apr 22, 2020

A team of Chinese scientists has recently developed two novel compounds that inhibit the SARS-CoV-2 main protease (Mpro) and one of them is a good drug candidate for further clinical studies.

The research, published online in Science on April 22, was conducted by Prof. LIU Hong and Prof. XU Yechun from the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences (CAS), Prof. YANG Haitao from the Shanghai Institute for Advanced Immunochemical Studies of ShanghaiTech University, Prof. ZHANG Lei-Ke from the Wuhan Institute of Virology of CAS, and their collaborators.

As of April 22, more than 2.5 million cases of COVID-19 have been confirmed, with more than 170 thousand deaths. No clinically effective vaccines or specific antiviral drugs are currently available for the prevention and treatment of COVID-19.

SARS-CoV-2 – the etiological agent responsible for the global COVID-19 outbreak – is an enveloped, positive-sense, single-stranded RNA virus and SARS-CoV-2 Mpro plays a vital role in its life cycle. Since SARS-CoV-2 Mpro has no human homologue, it is an ideal antiviral drug target.

After analyzing the substrate-binding pockets of SARS-CoV-2 Mpro, the scientists designed and synthesized two compounds, 11a and 11b. A fluorescence resonance energy transfer (FRET)-based cleavage assay was then used to determine their IC50 values. The results revealed excellent SARS-CoV-2 Mpro inhibitory activity for both 11a and 11b, with IC50 values of 0.053 ± 0.005 μM and 0.040 ± 0.002 μM, respectively.

The researchers also employed immunofluorescence, quantitative real-time PCR and plaque assay to monitor the antiviral activity of 11a and 11b. The results all showed that compounds 11a and 11b exhibited good anti-SARS-CoV-2-infection activity in cell culture (e.g., EC50 values were 0.53 ± 0.01 μM and 0.72 ± 0.09 μM, respectively, when using the plaque assay). In addition, these compounds showed good PK properties in vivo, suggesting they are promising drug candidates. However, the lower toxicity of compound 11a makes it particularly promising.

In order to elucidate the inhibition mechanism of SARS-CoV-2 Mpro in compounds 11a and 11b, the scientists determined the high-resolution crystal structure of complexes Mpro-11a (PDB: 6LZE) and Mpro-11b (PDB: 6M0K) at 1.5-A resolution. The high-resolution crystal structure of these complexes not only demonstrated SARS-CoV-2 Mpro-11a/11b interactions, but also revealed the mechanism of SARS-CoV-2 inhibition. High-resolution analysis of complexes is useful to medicinal chemists in designing novel inhibitors that act against SARS-CoV-2.

This study shows that structure-based drug design is an effective strategy for designing specific antiviral leads against SARS-CoV-2. Preclinical research on compound 11a is now proceeding. The team has decided to share its research data with scientists around the world to accelerate the development of anti-SARS-CoV-2 drugs.

In this study, the team led by Profs. LIU Hong, XU Yechun and JIANG Hualiang accomplished the design and synthesis of compounds and evaluated enzyme inhibitory activity; the team led by Profs. YANG Haitao and RAO Zihe determined the high-resolution crystal structure; and the team led by Profs. ZHANG Lei-Ke and XIAO Gengfu tested the antiviral activity. The research was also supported by the National Chengdu Center for Safety Evaluation of Drugs and Frontier Biotechnologies Inc.

Figure: Mpro-inhibitor binding modes for 11a and 11b. (Image by SIMM)

Structure-based Design of Antiviral Drug Candidates Targets SARS-CoV-2 Main Protease----Chinese Academy of Sciences

 

[JSCh]

https://twitter.com/x/status/1275695888401383425

https://twitter.com/x/status/1275075324485615625

 

[JSCh]

China's inactivated COVID-19 vaccine starts phase-3 clinical trial internationally
Source: Xinhua| 2020-06-24 15:59:18|Editor: huaxia

BEIJING, June 24 (Xinhua) -- China's inactivated COVID-19 vaccine candidate has started its phase-3 clinical trial globally in the United Arab Emirates, according to the vaccine developer China National Biotec Group (CNBG).

The clinical trial was officially initiated after a cooperation agreement was signed Tuesday, during a videoconference jointly held in Beijing, Wuhan and Abu Dhabi, the company said, adding that it is the first time that China's self-developed vaccine has carried out phase 3 clinical research internationally.

The CNBG will cooperate with Group 42 (G42), an Abu Dhabi-based artificial intelligence and cloud computing company, in the clinical trial. They will also cooperate in the localized production of the vaccine.

The inactivated vaccine developed by the Wuhan Institute of Biological Products under the CNBG completed its phase 1 and 2 clinical trials in China.

The results showed a good safety record and no severe adverse reactions were found in clinical trials, and vaccine receivers inoculated with two injections in different procedures and doses have all produced high titers of antibodies. For those receiving two injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reached 100 percent.

 

[JSCh]

China launches human trials for new COVID-19 vaccine
By Zhang Zhihao | chinadaily.com.cn | Updated: 2020-06-24 04:14

[Photo/VCG]

China has launched the world's first human trial of its recombinant protein vaccine candidate against COVID-19, which is a new type of vaccine that has shown to be safe and effective in animal models and is easy to mass produce, the vaccine developer said on Tuesday.

The vaccine was approved for phase one clinical trial by the National Medical Products Administration on June 19, according to a statement by the Institute of Microbiology of the Chinese Academy of Sciences. The details of the trial is still unknown.

It is the nation's third vaccine technologies, after the adenovirus vector vaccine and inactivated vaccine, to enter clinical trials in China. Chinese scientists and companies are now testing six vaccine candidates in humans, including one vector, four inactivated and one recombinant protein vaccine.

However, none of these candidates have passed the critical phase three clinical trial, which typically requires large number of recipients and be conducted in regions where the epidemic is still ongoing.

The new vaccine candidate is jointly developed by the institute and Anhui Zhifei Longcom Biopharmaceutical. Scientists from Israel also reported to be working on a recombinant protein vaccine, and the results of their animal testing was published on non-peer reviewed preprint server BioRxiv last week.

A recombinant protein vaccine involves using a specific piece of the virus, such as the spike protein of the antigen, to trigger a protective immune response, according to United States' National Institutes of Health. They are known to provide very strong protection and is very safe, though booster shots might be needed to get ongoing protection.

Some common recombinant vaccines include ones against Hepatitis B, influenza, whooping cough and Human papillomavirus or HPV.

The Chinese recombinant protein vaccine uses the spike protein of the novel coronavirus to elicit an immunological response, the institute said. It has been tested on mice and rhesus macaques and shown to produce highly potent virus neutralizing antibodies.

The viral load in the test animals have also decreased noticeably, reducing the virus's damage to the lung tissues, the institute added. Moreover, the technology used to manufacture the vaccine can be bolstered to industrial scale, with high production output, low cost and relatively strong practicality.

However, the institute stressed that the vaccine candidate still has much work to be done in human trials before reaching the market.

 

[JSCh]

JUNE 25, 2020 / 1:25 AM / UPDATED 12 HOURS AGO
Chinese military researchers move a new COVID vaccine candidate into human trial
Roxanne Liu, Se Young Lee

BEIJING (Reuters) - A Chinese military research institute has been approved to test its second experimental coronavirus vaccine in humans, the eighth candidate in clinical trials for China as it emerges as a front-runner in the global fight against COVID-19.

No vaccine has been approved for sale against the virus that has killed over 470,000 people, but more than a dozen candidates have entered different stages of human test globally.

The new drug is developed by the Academy of Military Science (AMS), a research institute affiliated with the People’s Liberation Army, and was approved to proceed to human trial by China’s National Medical Products Administration.

AMS’ latest candidate, named ARCoV, uses mRNA technology, an approach that is also used for candidates developed by Moderna Inc in the United States and German firm CureVac but has never been tested in China-based clinical trials, the institute said in its social media WeChat late on Wednesday.

“The core raw materials and equipment are all domestically produced, and rapid production capacity ramp-up is achievable,” Qin Chengfeng, a researcher responsible for the mRNA project, said in the statement.

The Chinese Clinical Trial registry, without naming ARCoV, said a phase 1 clinical trial for an mRNA vaccine, sponsored by AMS, Yunnan Walvax Biotechnology and Suzhou Abogen Biosciences, would start on Thursday and evaluate the safety of the candidate. here

Separately, Ad5-nCoV, a vaccine candidate co-developed by AMS and CanSino Biologics using a different technique, is under phase-2 clinical trial in China and has won approval to begin human testing in Canada.

Reporting By Roxanne Liu and Se Young Lee in Beijing; editing by Peter Henderson and Cynthia Osterman


Chinese military researchers move a new COVID vaccine candidate into human trial - Reuters

 

[JSCh]

https://twitter.com/x/status/1277448750357606401

https://twitter.com/x/status/1277148344104747008

 

[JSCh]

Chinese company unveils positive results of COVID-19 vaccines
By Leng Shumei and Hu Yuwei Source:Global Times Published: 2020/6/28 20:08:43

A staff member displays a sample of the COVID-19 inactivated vaccine at a vaccine production plant of China National Pharmaceutical Group (Sinopharm) in Beijing, capital of China, April 10, 2020. Photo:Xinhua

An institute of biological products in Beijing affiliated with the China National Pharmaceutical Group (Sinopharm) announced on Sunday that it had achieved positive results for a COVID-19 vaccine candidate it developed.

The development came as the global number of confirmed patients exceeded 10 million as of 6:30 pm Sunday (Beijing time).

Three of the four inactivated COVID-19 vaccines developed in China evoked positive immune responses in Phase I and II clinical trials, indicating that China has made great progress in the research and development (R&D) of this type of vaccine, experts said.

The Beijing institute, which is under the Sinopharm China National Biotec Group (CNBG), said in a statement sent to the Global Times that all 1,120 volunteers in the first and second phase clinical trials successfully produced high-titer antibodies against COVID-19 after accepting two doses of the vaccine.

The vaccine has proven to be effective and safe, read the statement.

The clinical trials started on April 27 in Shangqiu county, Central China's Henan Province and were designed as randomized, double-blind and placebo-controlled studies, according to the statement.

Another institute under CNBG in Wuhan, Central China's Hubei Province, on June 16 announced the results of Phase I and II clinical trials of a vaccine candidate it developed. This provided further vital data for CNBG's research of inactivated COVID-19 vaccines, read the statement.

On June 23, CNBG announced that it had agreed with authorities in the United Arab Emirates to start Phase III clinical trials for inactivated vaccine candidates CNBG developed. The group did not say which vaccines were involved.

Experts said that if human trials go well overseas, the third phase trial will be closed in August, followed by medical observation in September, with data revealed as soon as October. A vaccine could then be approved for marketing after positive results at the end of October.

Sinopharm is expanding manufacturing capacity for COVID-19 vaccines. One plant in Beijing and one in Wuhan can together produce at least 200 million doses annually, according to media reports.

The plant in Beijing is the largest manufacturing center for COVID-19 vaccines worldwide, reports said.

However, mass production of inactivated vaccines is still facing the initial challenge of insufficient capacity, warned experts.

"Each person needs two doses of the inactivated vaccine to evoke an immune response, and 200 million doses would only meet the immunization needs of 100 million people. This is still far from enough for China and the world at a time when vaccines are urgently needed," Tao Lina, a Shanghai-based vaccine expert, told the Global Times on Sunday.

China is developing COVID-19 vaccines in five categories - inactivated vaccines, recombinant protein vaccines, live attenuated influenza vaccines, adenovirus vaccines and nucleic acid-based vaccines, reports said.

Except for live attenuated influenza vaccines, all four types have entered human clinical trials, showing that the progress of R&D for COVID-19 vaccines in China is markedly faster than in the US, analysts noted.

Several other types of vaccines, if developed successfully, are theoretically more productive than inactivated vaccines, said Tao.

"The World Health Organization (WHO) expects 2 billion doses of vaccine to be available worldwide by the end of 2021. Inactivated vaccines alone will certainly not be enough," Tao said.

The WHO released plans on Friday that target delivery of 500 million tests to low- and middle-income countries (LMICs) by mid-2021, 245 million courses of treatments to LMICs by mid-2021, and 2 billion vaccine doses, of which 1 billion will be purchased for LMICs by the end of 2021.

According to the WHO's website, there are 16 COVID-19 candidate vaccines in clinical trials worldwide, of which seven are being developed by Chinese companies or jointly developed by Chinese and foreign companies.

 

[JSCh]

Clinical human trials begin for COVID-19 vaccine in China - Global Times
Source:Global Times Published: 2020/3/21 16:09:05

A multi-center clinical trial for China's self-developed AIDS vaccine started this year and is currently in progress. Photo: VCG

Chinese volunteers in a clinical trial for the first COVID-19 vaccine, developed by the country's military scientists, received their injections on Friday, media reported on Saturday.

The product is a recombined vaccine developed by a team headed by Chen Wei, an expert at expert at biological hazard prevention and control from the PLA Academy of Military Medical Sciences and major general of the Chinese military. The team undertook pharmaceutical and toxicological research for a COVID-19 vaccine in cooperation with local companies, based on their previous successful experience in developing an Ebola vaccine.

Unlike other clinical trials, in the trial conducted by Chen's team, volunteers do not need to be infected with the novel coronavirus after receiving the vaccination. Rather, the researchers will test if anti-bodies have been created and if the volunteers have become immune to the virus.

The first batch of volunteers, all Wuhan permanent residents aged between 18 and 60, has been divided into three groups, each consisting of 36 members.

They will be quarantined for 14 days and researchers will follow them for six months to monitor any adverse reactions.

The vaccine developed by Chen's team passed a clinical research registration review and was approved for clinical trial on Monday night, about 19 hours after the US announced it would start human trials for the first coronavirus vaccine, revealing the two largest economies are level in the race to resolve the public health crisis.

US researchers administered the first injections in the country's first trial of an experimental coronavirus vaccine on Monday.

COVID-19 vaccine receives special military drug approval in China
Source:Global Times Published: 2020/6/29 9:28:40

A staff member displays samples of the COVID-19 inactivated vaccine at Sinovac Biotech Ltd., in Beijing, capital of China, March 16, 2020. (Xinhua/Zhang Yuwei)

Innovative Chinese biopharmaceutical firm CanSino Biologics Inc announced on Monday that a recombinant novel coronavirus vaccine (Ad5-nCoV) the company developed with a military research team has received special military drug approval, with a validity of one year.

Ad5-nCoV is currently limited to military use and cannot be expanded to a broader vaccination range without the approval of the Health Bureau of the Logistics Support Department under the Central Military Commission, the company said in a statement filed with Hong Kong Exchanges and Clearing Ltd.

The vaccine is being jointly developed by CanSino and the Institute of Biotechnology under the Academy of Military Medical Sciences. The company said on March 18 that Ad5-nCoV had won approval for clinical trials.

Phase 1 and phase 2 clinical trials for Ad5-nCoV have been conducted in China, with phase 2 trials unblinded on June 11, 2020, according to the company. Data from the clinical trials showed a good safety profile and high levels of humoral and cellular immune responses. The overall clinical results indicate Ad5-nCoV has the potential to prevent diseases caused by SARS-CoV-2.

It's worth noting that CanSino announced its collaboration with the Canadian National Research Council on clinical trials for the recombinant vaccine in May, though it didn't disclose further details.

 

[JSCh]

Vaccine development center in Wuhan completed
By ZHOU LIHUA and AYBEK ASKHAR | China Daily | Updated: 2020-07-03 09:46

An employee conducts an impurity test on COVID-19 inactivated vaccine samples at a production plant of China National Pharmaceutical Group (Sinopharm) in Beijing, on April 14, 2020. [Photo/Xinhua]

A medical complex comprising a COVID-19 vaccine development lab and a vaccine production department was completed in Wuhan, Hubei province, on Wednesday. It is expected to produce about 100 million doses of vaccine per year.

The complex, under the Wuhan Institute of Biological Products of China National Pharmaceutical Group (Sinopharm), has large-scale production capability for the inactivated COVID-19 vaccine and can host researchers of the vaccine and other highly pathogenic viruses.

Construction manager Yang Gang, who previously participated in the building of two makeshift hospitals－Hongshenshan and Leishenshan－within 10 days, said construction finished four months ahead of schedule with the efforts of over 400 workers.

According to Yang, all the seams in the buildings are tightly sealed, and an advanced ventilation system was installed during construction to prevent the leakage of harmful substances.

"The completion of the complex is a clarion call for mass production of the inactivated COVID-19 vaccine. I hope the group will take this opportunity to speed up large-scale production of the vaccine and put it on the market as soon as possible," Cao Guangjing, vice-governor of Hubei, said at a ceremony marking the completion on Wednesday.

The inactivated vaccine candidate developed by Sinopharm and the Wuhan Institute of Virology under the Chinese Academy of Sciences started clinical trials on April 12.

Wang Junzhi, an academician at the Chinese Academy of Engineering, said the inactivated vaccines, which use killed pathogenic microorganisms to enhance immune response, have the advantages of a mature production process, controllable quality standards and a wide range of protections.

According to Wang, the country has laid a solid foundation for research into inactivated vaccines in recent years. Inactivated vaccines have been widely used to fight diseases like influenza and polio.

Sinopharm recently announced the inactivated vaccine candidate they developed had completed phase 1 and 2 clinical trials in China, and it started phase 3 trials on June 24.

Sinopharm had announced that the results of the phase 1 and 2 trials showed a good safety record and no severe adverse reactions after a double-blind clinical trial, and that those who received the vaccine all produced a high level of antibodies.

According to Sinopharm, another production department under the group in Beijing has also been completed and is expected to produce about 120 million doses of vaccine per year.

 

[JSCh]

Sinovac Announces Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19

• Date: 2020-06-13

中文稿（Chinese Version）：科兴中维新型冠状病毒灭活疫苗I/Ⅱ期临床研究揭盲，初步结果显示该疫苗具有良好的安全性和免疫原性

Beijing-June 13, 2020 — Sinovac Biotech Ltd. ( “Sinovac” or the “ Company”)(Nasdaq: SVA), a leading provider of biopharmaceutical products in China, today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles.

The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials. Of those, 143 volunteers are in phase I and 600 volunteers are in phase II. There have been no severe adverse event reported in either the phase I or phase II trials. The phase II clinical trial results show that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The neutralizing antibody seroconversion rate is above 90%, which concludes the vaccine candidate can induce positive immune response.

The Company expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (announced on June 11, 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study. The Company expects to share the full data on our clinical trials with the public through academic publications.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “Our phase I/II study shows CoronaVac is safe and can induce immune response. Concluding our phase I/II clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19. We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19. Like with our other vaccines, we are committed to developing CoronaVac for global use as part of our mission of supplying vaccines to eliminate human diseases.”

As announced previously, Sinovac’s development of a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China. The Company received approval from China’s NMPA on April 13 to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China.


Sinovac Announces Positive Preliminary Results of Phase I/II Clinical Trials for Inactivated Vaccine Candidate Against COVID-19-SINOVAC - SINOVAC

Chinese COVID-19 vaccine approved to enter Phase III clinical trial in Brazil
By Hu Yuwei and Leng Shumei Source:Globaltimes.cn Published: 2020/7/7 2:07:46

Beijing-based Sinovac Life Sciences Co announced on Monday that its COVID-19 vaccine collaboration with Brazilian immunobiologic producer Instituto Butantan has received approval from the Brazilian regulator for phase III clinical trials.

The Brazilian National Regulatory Agency, Anvisa, granted approval to a phase III clinical trial sponsored by Instituto Butantan on Friday to test the efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co in Brazil. This trial aims to be a pivotal study to support the licensing of the product, according to an official statement the company sent to the Global Times.

The trial will recruit nearly 9,000 healthcare professionals to work in COVID-19 specialized facilities in 12 clinical sites in several states in Brazil. The recruitment is scheduled to start this month after ethical approval is obtained from each clinical site.

The study will be a double-blind placebo-controlled trial with participants randomly allocated a 1:1 ratio of placebo and vaccine, according to the announcement from Instituto Butantan on Thursday.

The immunization schedule is two doses of intramuscular injections (deltoid) with a 14-day interval, it said.

For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule.

For safety and immunogenicity, participants are categorized in two age groups, adults (18-59 years) and elderly (60 years and above). All participants will be followed for up to 12 months.

Anvisa reviewed the detailed manufacturing information, the results of the previous two clinical trials of the vaccine candidate, and late-stage trial protocols developed by Instituto Butantan. It took only about two weeks for the agency to fast-track the application due to the public health emergency.

The review was conducted at the highest standards and met with international rules. Anvisa is qualified as a fully functional regulatory agency for the WHO prequalification process. The agency is also a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), according to the statement.

"The phase III clinical trial approval is a demonstration that the Sinovac and Instituto Butantan partnership is an efficient collaboration, offering hope to save lives worldwide," commented Dr Dimas Covas, director of Instituto Butantan.

"We are pleased to advance to Phase III trials with Instituto Butantan, which will take us one step further in our commitment to develop vaccines for global use and our mission of supplying vaccines to eliminate human diseases," Weidong Yin, chairman, president and CEO of Sinovac, commented in the statement.

Sinovac announced on June 13 positive preliminary results in Phase I/II clinical trials for the inactivated vaccine, which showed favorable immunogenicity and safety profiles.

The Phase II results showed that the vaccine induces neutralizing antibodies within 14 days. The neutralizing antibody seroconversion rate is above 90 percent.

Brazil has become a new epicenter of the pandemic. The country has reported more than 1,600,000 confirmed COVID-19 cases as of Monday.

The cooperation is expected to achieve a win-win outcome as a vaccine can help end the grim epidemic in Brazil. China, in contrast, has become less favorable as a late-stage clinical trial hub, given its smaller number of new cases.

The two parties aim to establish extensive collaboration in technology licensing, market authorization and commercialization of the vaccine, according to an announcement Sinovac sent to the Global Times on Tuesday.

On June 29, Sao Paulo state Governor Joao Doria said 9,000 volunteers have already been registered to test the vaccine against COVID-19, Reuters reported.

Instituto Butantan will spend 85 million reals ($17.1 million) to conduct trials on 9,000 Brazilian volunteers, the governor said, adding that if the vaccine proves effective, it could be mass-produced in São Paulo, starting from the first half of next year, and administered to millions of Brazilians free of charge.

The company has partnered with several companies outside of China for phase III efficacy studies, Sinovac told the Global Times.

 

[JSCh]

https://twitter.com/x/status/1282132183801462785

Global Times@globaltimesnews

China's #CanSino Biologics is holding talks with #Russia, #Brazil, #Chile and #SaudiArabia on starting phase III trials of #COVID19 vaccine (AD5-NCOV), planning to enroll 40,000 participants. This came after the vaccine was approved for use in army
9:58 AM · Jul 12, 2020