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Clinical human trials begin for COVID-19 vaccine in China

Indonesia in cooperation with Chinese firm to produce COVID-19 vaccine in early 2021
Source: Xinhua| 2020-07-13 22:25:07|Editor: huaxia

JAKARTA, July 13 (Xinhua) -- Indonesian President Joko Widodo said on Monday that the country would most likely commence producing COVID-19 vaccine at the beginning of next year in cooperation with Chinese firm Sinovac Biotech Ltd.

President Jokowi, the popular name of the president, said about 170 million doses of vaccine will be produced next year, although it was short of the country's need of 347 million doses.

"We have cooperated with Sinovac. It is predicted that the production will start from January to April next year," the president said at the State Palace.

Medical workers, COVID-19 vulnerable groups and those living in high risk-areas or red zones would be prioritized to be vaccinated for the pneumonia-causing disease, said Jokowi.

Indonesia's state firm PT Bio Farma in cooperation with Sinovac Biotech has carried out clinical tests for the COVID-19 vaccine since July, according to Jokowi.

Besides, Indonesia's firm PT Kalbe Farma teaming up with South Korea's firm Genexine Inc. has also conducted clinical tests of the vaccine, he said.

The number of daily infection cases in Indonesia is still over 1,000, as more areas have nearly obliterated the transmission of the virus.

The Health Ministry reported 1,282 additional cases in the country on Monday, bringing the total to 76,981 with 3,656 fatalities.
 
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Chinese vaccine candidate immune to all known strains of coronavirus and improving: Sinopharm
By Fan Wei Source: Global Times Published: 2020/7/16 16:20:26

A Chinese-developed inactivated vaccine candidate against the coronavirus is immune to all detected strains of the virus so far, and its incidence and degree of adverse reactions are much lower than the same type of inactivated vaccines for other diseases already on the market, the head of the vaccine candidate's producer told the Global Times in an exclusive interview on Monday.

"The inactivated vaccine we developed can cover all strains of the coronavirus that have been detected so far, including the virus strains tracked in the Xinfadi market in Beijing," Yang Xiaoming, president of China National Pharmaceutical Group (Sinopharm), noted in response to public concerns that the vaccine under the R&D process would be ineffective as the virus mutates.

The research team has carried out cross-protection experiments to test if the anti-serum obtained by immunizing animals can produce an immune response to different genotypes of strains of coronavirus, Yang said.

Sinopharm, whose COVID-19 inactivated vaccine candidates have been delivered into phase three clinical trials, have stored more than 4 million doses of the vaccines, the Global Times learned from the group.

Yang said that the group is currently storing more COVID-19 vaccines. Once a candidate is approved for the market, the storage will be enough to meet domestic demand for vaccination.

Yang estimated that an inactivated COVID-19 vaccine will be available on the market at the end of this year or early 2021. Two inactivated COVID-19 vaccine candidates separately developed by Sinopharm institutes in Beijing and Wuhan entered clinical trials in April.

The results of phase one and two clinical trials of the two candidates were revealed in June, showing that all receptors have created high-titer antibodies.

Skepticism and pessimism of Chinese-developed COVID-19 vaccines have been raised in some Western media, which have exaggerated the side effect ratio reported in early-stage clinical trials of another vaccine candidate, the Ad5-nCoV recombinant novel coronavirus vaccine.

Vaccine experts advised the public not to panic over the side effects revealed in the preliminary results of the Chinese-developed coronavirus vaccine, as the adverse reactions exposed are tolerable and the vaccine is under constant optimization.

Yang also reveals that more than 1,000 Sinopharm group employees have been receiving injections on a voluntary basis, and the results show a promising trend that the vaccine is safe and effective, with low incidence and degree of adverse reactions.

At the end of May, 180 volunteers from Sinopharm received inactivated COVID-19 vaccinations, and their antibodies have reached levels resistant to the coronavirus with a 100 percent protective rate.

On June 23, Sinopharm signed agreements with the United Arab Emirates (UAE) government to conduct COVID-19 vaccine candidate phase three clinical trials in the country, the world's first COVID-19 vaccine candidate phase three clinical trials to have been launched.
 
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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.

Chinese COVID-19 vaccine approved for Phase III clinical trials in Bangladesh
Source: Global Times Published: 2020/7/20 20:48:42

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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)

A COVID-19 vaccine candidate developed by Beijing-based Sinovac Life Sciences Corp has obtained preliminary approval in Bangladesh for entering phase III clinical trials, the company said Monday.

"Our vaccine has received approval from a national drug research council in Bangladesh and is waiting to obtain final approval from Bangladesh's drug regulator, the Directorate General of Drug Administration for phase III clinical trials," Liu Peicheng, a spokesperson from Sinovac told the Global Times. No further details were given.

The latest progress came after Sinovac obtained approval in Brazil in early July to conduct phase III clinical trials to test the efficacy and safety of inactivated COVID-19.

Liu said that the first shot of the company's COVID-19 vaccine for the latest phase of clinical trials will be given to volunteers in Sao Paulo, Brazil on Monday afternoon (local time).

On Sunday, the company's COVID-19 vaccines arrived in Indonesia for phase III clinical trials, in cooperation with Indonesian state-owned enterprise Bio Farma.

He said that the company chose foreign companies and governments to conduct phase III clinical trials based on the situation of the new viral outbreak and the local government's willingness.

"We hope to compare trial results on a global platform in order to get a scientific and precise result," he said.

Sinovac said in June that preliminary results of phase I and II clinical trials for its COVID-19 vaccine showed favorable immunogenicity and safety profiles. A total of 743 healthy volunteers aged 18 to 59 enrolled in the trials.

As the COVID-19 outbreak has been put under control in China, domestic vaccine firms are seeking cooperation with foreign institutions and companies for further research. Chinese biopharmaceutical firm CanSino Biologics Inc said in May that it had got approval from the Canadian National Research Council to conduct clinical trials for a recombinant novel coronavirus vaccine developed by the company with a military research team.
 
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Chinese COVID-19 vaccine could be ready by end of 2020: SinoPharm
Source: Global Times Published: 2020/7/23 10:04:33
Though the COVID-19 situation in China has been largely eased, Chinese pharmaceutical companies have been actively participating in the development of vaccines, with some already completing early trials and anticipating market entry by the end of the year, ahead of schedule.

Liu Jingzhen, chairman of China National Pharmaceutical Group (SinoPharm), said in a recent media interview that the results of phase I and II clinical trials were very positive and without serious side effects.

"SinoPharm was approved at the end of June to begin international phase III clinical trials and [the vaccine] could be on the market by the end of the year," Liu said, adding that phase III trials should be completed in about three months and are in the final stages of approval.

This came after a World Health Organization expert said on Wednesday that researchers are making good progress in developing vaccines against COVID-19, with a handful in late-stage trials, but their first use cannot be expected until early 2021.

SinoPharm's novel coronavirus vaccine entered domestic phase I and II clinical trials on April 12; its effect is considered ideal, and no one experienced a serious side effect, according to Liu, who noted that he himself had received an injection to test the vaccine on March 30.

The vaccine was jointly developed by the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products under SinoPharm.

The two institutes simultaneously built P3-level production facilities which can ensure the large-scale production of vaccine in the next stage, Liu said.

"So far, it's going well. It is leading the world in research and development, clinical trials, manufacturing facilities, and vaccine efficacy, safety, and accessibility," said Liu in the interview.

In the first half of 2020, novel coronavirus vaccines were under research and development by at least six groups in China, including a leading group for scientific research headed by Yang Xiaoming of SinoPharm and a team led by Chen Wei from the Institute of Biotechnology under the Academy of Military Medical Sciences.

In the US, three vaccines were under research and development in the first half, including those from Moderna and Pfizer.

Other COVID-19 vaccines are also in development - including one at the University of Oxford in the UK - and have also entered clinical trials.
 
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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
NEWS RELEASE 24-JUL-2020
Another mRNA-based vaccine candidate protects animals against SARS-CoV-2 | EurekAlert! Science News
CELL PRESS

An experimental messenger RNA (mRNA)-based vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) elicits protective immune responses in mice and non-human primates, researchers report on July 23rd in the journal Cell. Two injections of the vaccine were sufficient to induce robust immunity, completely preventing SARS-CoV-2 infection in mice.

"The robust protection observed in the present studies and the clear immune correlates of protection pave the path forward for future COVID-19 vaccine development in humans," says senior study author Cheng-Feng Qin of the Beijing Institute of Microbiology and Epidemiology.

mRNA-based vaccines are attractive options for protecting against SARS-CoV-2 because they can be rapidly designed and manufactured at a large scale within weeks. Moreover, preclinical studies have demonstrated that mRNA-based vaccines induce potent and broadly protective immune responses against various pathogens with an acceptable safety profile.

In the Cell study, Qin and his colleagues developed a vaccine consisting of mRNA that encodes the receptor-binding domain (RBD) of the spike (S) protein, which is located on the surface of SARS-CoV-2. The vaccine, named ARCoV, is encapsulated in lipid nanoparticles, which improves delivery into tissues.

Targeting RBD rather than the entire S protein may represent a safer option, potentially triggering the production of fewer non-neutralizing antibodies. These antibodies could enhance viral entry into cells and viral replication through a process called antibody-dependent enhancement of infection, which has been previously reported for the related virus SARS-CoV--the causative agent of the SARS outbreak in 2002 to 2003.

The researchers injected ARCoV into the muscle tissue of 16 mice and provided a booster shot two weeks later. The vaccine elicited the production of high levels of neutralizing antibodies, which protect host cells by preventing the virus from interacting with them. These antibodies were cross-reactive, offering broad protection against three different strains of SARS-CoV-2. In addition, the vaccine increased the number of T cells in the spleen.

Mice that received two doses of ARCoV and were exposed to SARS-CoV-2 35 days later showed no signs of viral RNA in the lungs or trachea and no lung damage or inflammation. Results from 20 cynomolgus monkeys showed that two ARCoV doses induced a virus-specific T cell response and the production of neutralizing antibodies at levels that far exceed those seen in most recovered COVID-19 patients. Moreover, none of the vaccinated animals experienced adverse effects.

To assess the thermal stability of ARCoV, the researchers stored the vaccine at various temperatures for one, four, or seven days, injected it into mice, and visualized its tissue distribution. The results showed that the vaccine was effectively delivered to tissues, achieving the same high level of expression after being stored at room temperature for one week, without any signs of decreased activity. "A ready-to-use and thermostable vaccine like ARCoV is highly desirable to eliminate the need for cold-chain transportation," Qin says.

The researchers are currently evaluating the long-term stability of ARCoV. "In addition, the duration of neutralization antibody induced by ARCoV is yet to be determined, as experience from other human coronaviruses has indicated the possibility of re-infection due to waning of the antibody response," Qin says. "Future studies are needed to evaluate the long-term immune response in animal models and the effectiveness of ARCoV in humans."


 
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HK, Macao scientists eye low-cost mass production of new vaccine
By Zhang Hui Source: Global Times Published: 2020/8/3 20:55:57

af3c68b0-7134-4a56-868b-f1b3e76f3ef3.jpeg
Samples of the COVID-19 inactivated vaccine are seen at a vaccine production plant of China National Pharmaceutical Group (Sinopharm) in Beijing, capital of China, April 10, 2020.Photo:Xinhua

As scientists globally race to develop effective COVID-19 vaccines, scientists from Hong Kong and Macao special administrative regions announced a breakthrough in developing a recombinant COVID-19 vaccine on Monday, indicating that the mass production of the vaccine is feasible at a low cost in the future.

They have evaluated the potential of a candidate vaccine based on the receptor-binding domain (RBD) of SARS-CoV-2, and found that a recombinant vaccine could induce a potent functional antibody response in immunized mice, rabbits and non-human primates as early as seven to 14 days after a single dose.

The research, conducted by the Hong Kong Polytechnic University (PolyU) and the Macau University of Science and Technology (M.U.S.T.) in collaboration with Chinese mainland institutions, was recently published in the scientific journal Nature, in a paper entitled, "A vaccine targeting the RBD of the S protein of SARS-CoV-2 induces protective immunity."

Zhang Kang, a professor from the Faculty of Medicine of M.U.S.T., the author of the study, said at Monday's press conference that the biotechnology method used in creating the recombinant vaccine is mature, as many vaccines on the market, such as human papillomavirus (HPV) and flu vaccines, adopted the same method, and that makes the recombinant vaccine feasible for mass production.

"Manufacturing the most vaccines at the least cost is a key issue in vaccine production, and this vaccine could be mass produced at a low cost," Zhang said. He said that the vaccine will be available in Hong Kong, Macao and other regions and countries.

Johnson Lau, adjunct professor of the Department of Applied Biology and Chemical Technology at PolyU, told the Global Times at the press conference that the team has started engaging with several collaborators for mass production, and some contracts have been signed.

The vaccine will start human clinical trials in "at most months, if not weeks," Lau said.

Five Chinese COVID-19 vaccines have entered the clinical trial stage - one adenovirus vector vaccine and four inactivated vaccines - accounting for 40 percent of clinical-stage vaccines worldwide, according to the Ministry of Science and Technology.

Tao Lina, a Shanghai-based vaccine researcher, told the Global Times on Monday that some domestically made COVID-19 vaccines have entered phase three clinical trials, which usually takes about two to three months. These vaccines may be available for mass production by the end of the year, he said.

Recombinant vaccines are much easier to be mass produced at a lower cost compared to inactivated vaccines, Tao said.

Russia plans to launch a mass vaccination campaign in October, and the US company Moderna announced in late July it began phase three trials of a COVID-19 vaccine in the US.

Reuters reported on Friday, citing an unnamed US security official, that China-backed hackers tried to steal "valuable data" from Moderna.

Tao said such allegations are purely "nonsense," as many Western vaccine companies including Moderna used the gene sequencing date published by China to develop their vaccines.

 
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Chinese COVID-19 vaccine could be ready by end of 2020: SinoPharm
Source: Global Times Published: 2020/7/23 10:04:33
Though the COVID-19 situation in China has been largely eased, Chinese pharmaceutical companies have been actively participating in the development of vaccines, with some already completing early trials and anticipating market entry by the end of the year, ahead of schedule.

Liu Jingzhen, chairman of China National Pharmaceutical Group (SinoPharm), said in a recent media interview that the results of phase I and II clinical trials were very positive and without serious side effects.

"SinoPharm was approved at the end of June to begin international phase III clinical trials and [the vaccine] could be on the market by the end of the year," Liu said, adding that phase III trials should be completed in about three months and are in the final stages of approval.

This came after a World Health Organization expert said on Wednesday that researchers are making good progress in developing vaccines against COVID-19, with a handful in late-stage trials, but their first use cannot be expected until early 2021.

SinoPharm's novel coronavirus vaccine entered domestic phase I and II clinical trials on April 12; its effect is considered ideal, and no one experienced a serious side effect, according to Liu, who noted that he himself had received an injection to test the vaccine on March 30.

The vaccine was jointly developed by the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products under SinoPharm.

The two institutes simultaneously built P3-level production facilities which can ensure the large-scale production of vaccine in the next stage, Liu said.

"So far, it's going well. It is leading the world in research and development, clinical trials, manufacturing facilities, and vaccine efficacy, safety, and accessibility," said Liu in the interview.

In the first half of 2020, novel coronavirus vaccines were under research and development by at least six groups in China, including a leading group for scientific research headed by Yang Xiaoming of SinoPharm and a team led by Chen Wei from the Institute of Biotechnology under the Academy of Military Medical Sciences.

In the US, three vaccines were under research and development in the first half, including those from Moderna and Pfizer.

Other COVID-19 vaccines are also in development - including one at the University of Oxford in the UK - and have also entered clinical trials.
 
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Indonesia in cooperation with Chinese firm to produce COVID-19 vaccine in early 2021
Source: Xinhua| 2020-07-13 22:25:07|Editor: huaxia

JAKARTA, July 13 (Xinhua) -- Indonesian President Joko Widodo said on Monday that the country would most likely commence producing COVID-19 vaccine at the beginning of next year in cooperation with Chinese firm Sinovac Biotech Ltd.

President Jokowi, the popular name of the president, said about 170 million doses of vaccine will be produced next year, although it was short of the country's need of 347 million doses.

"We have cooperated with Sinovac. It is predicted that the production will start from January to April next year," the president said at the State Palace.

Medical workers, COVID-19 vulnerable groups and those living in high risk-areas or red zones would be prioritized to be vaccinated for the pneumonia-causing disease, said Jokowi.

Indonesia's state firm PT Bio Farma in cooperation with Sinovac Biotech has carried out clinical tests for the COVID-19 vaccine since July, according to Jokowi.

Besides, Indonesia's firm PT Kalbe Farma teaming up with South Korea's firm Genexine Inc. has also conducted clinical tests of the vaccine, he said.

The number of daily infection cases in Indonesia is still over 1,000, as more areas have nearly obliterated the transmission of the virus.

The Health Ministry reported 1,282 additional cases in the country on Monday, bringing the total to 76,981 with 3,656 fatalities.
AUGUST 11, 2020
Indonesia starts human trials of China-made virus vaccine | MedicalXpress

coronavacisa.jpg
CoronaVac is already being tested on 9,000 health workers in Brazil

Indonesia on Tuesday launched human trials of a Chinese-made coronavirus vaccine with some 1,600 volunteers slated to take part in the six-month study.

The vaccine candidate, produced by Sinovac Biotech, is among just a few in the world to enter Phase 3 clinical trials, or large-scale testing on humans—the last step before regulatory approval.

The treatment, known as CoronaVac, is already being tested on 9,000 health workers in Brazil, the second-hardest-hit country in the coronavirus pandemic after the United States.

Indonesia, the world's fourth most populous country, has been struggling to contain its mounting virus cases, with more than 127,000 confirmed infections and over 5,700 deaths.

But the true scale of the public health crisis is believed to be much bigger, given the Southeast Asian nation's low testing rates.

The governor of Indonesia's most populous province, West Java, was among 1,620 volunteers slated to take part in clinical testing, which was set to wrap up in February.

If the vaccine proves safe and effective, Indonesian officials said, there were plans to produce up to 250 million doses for the sprawling archipelago of nearly 270 million, although they gave few details of the tentative roll-out.

On Tuesday, Indonesia's President Joko Widodo toured a factory in Bandung city, operated by state-owned pharmaceutical firm Bio Farma, where production would begin.

"Once again I want to highlight that the COVID-19 threat will not end until all people in Indonesia are vaccinated," Widodo said ahead of the tour.
 
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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
Reuters @Reuters

Mexico to conduct trials for China, U.S. COVID-19 vaccines, eyes production https://reut.rs/2XQojFc


Arab News Japan @ArabNewsjp

Saudi Arabia is prepared for a third stage test of the #COVID19vaccine developed by the Chinese company #CanSino, with at least 5,000 volunteers taking part, says health ministry. https://arab.news/56peq
 
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China likely to take lead along Russia in accelerated global vaccine race: experts
By Leng Shumei, Zhang Hongpei and Hu Yuwei Source: Global Times Published: 2020/8/12 23:13:44

The battlefield of a global vaccine race has seemingly transferred from research and development to the market after Russia announced its approval of the world's first COVID-19 vaccine on Tuesday, soon after which the US announced to purchase another 100 million doses of a domestic candidate, revealing the Trump administration's anxiety over Russia's move.

Chinese experts predicted that the move will be a big leap indicating that humans are moving from research and development (R&D) on a COVID-19 vaccine to the market, which would encourage more nations to accelerate their pace while the COVID-19 pandemic has not yet been brought under control globally.

Currently in the vaccine race, China, the US, Russia and some European countries have been at a similar pace in the R&D of a COVID-19 vaccine in recent months, and China is likely to stand out after Russia, experts noted.

Confirmed COVID-19 cases have exceeded 20 million worldwide as of Wednesday, according to the World Health Organization (WHO).​

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Following Russia's announcement on Tue that it has registered the world's 1st vaccine for COVID-19, how soon will a vaccine be made available? - 6 vaccines have entered Phase-III clinical trials, including 3 developed by China - 28 in clinical trials - 139 in preclinical stages

Along with the announcement of the approval, Russian officials also revealed on Tuesday that they had received orders from 20 countries for more than 1 billion doses and Russia is ready to manufacture 500 million doses of the vaccine, an adenovirus vector vaccine, per year in five countries, amid strong suspicion from some Western scientists and politicians over the vaccine as no experimental data has been released to prove its safety and efficacy.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases of the US, said that he seriously doubts that Russia had "actually, definitively proven that the vaccine is safe and effective," ABC News reported Wednesday.

At a briefing on Wednesday morning, US Health and Human Services Secretary Alex Azar criticized the Russian vaccine for being "non-transparent" as the data from the initial trials in Russia have not been disclosed.

Russian officials previously told media that they were preparing experimental data of the vaccine and planned to release it for peer review in August. A Reuters report on Tuesday also indicated that super-fast approval could mean that potential adverse effects of a vaccine may not be picked up, citing a British drug researcher.

Chinese researchers reached by the Global Times on Wednesday admitted that it is hard to judge the safety and efficacy while there is no data available, but they noted that as the technology of developing and producing adenovirus vector is mature, it is very likely Russia will succeed, which, if taking place, will be huge encouragement for the world.

The vaccine approval procedure is similar in most countries, with a total of three-phase clinical trial results required before formal approval in order to maximize the effectiveness and safety of the vaccine, said Tao Lina, a Shanghai-based vaccine expert on Tuesday.

Russia's current fast-tracked development may be due to their strong concerns over a worsening epidemic in the coming winter. This may compromise the effectiveness of its vaccine, but its safety is still reliable although data on its phase-2 trials have not been released, according to Tao.

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Russian President Vladimir Putin chairs a meeting with members of the government in a teleconference call at the Novo-Ogaryovo state residence outside Moscow, on Tuesday. Putin claims Russia has developed the first vaccine offering sustainable immunity against the novel coronavirus. Photo: AFP

The eventual success of the Russian-developed vaccine will be a huge boost to the world, representing a huge breakthrough for a vaccine against the novel coronavirus that hasn't been successfully marketed yet, Tao noted.

Analysts pointed out that apart from scientific concerns, the Western media's hyping of safety and efficacy issues regarding Russia's vaccine is more due to political reasoning and protection for their own domestic vaccine producers.

After Russia announced its approval on Tuesday, later the same day, US President Donald Trump announced the US government will purchase 100 million doses of Moderna's experimental coronavirus vaccine.

With the latest deal, the US government has reportedly spent $9.4 billion on ordering 700 million doses worth of COVID-19 vaccines with five companies, naming Moderna, GlaxoSmithKline and Sanofi, Pfizer, Novavax, Johnson & Johnson and AstraZeneca.

More countries will accelerate their procedures to develop and market their vaccine candidates, Chinese experts predicted, while warning of a blind competition, and emphasizing safety and efficacy.

Ready for production

Six COVID-19 vaccine candidates, including three from China - Sinovac, Wuhan's Institute of Biological Products/Sinopharm and Beijing's Institute of Biological Products/Sinopharm, have entered phase-3 trials, the WHO announced on Monday, while the other three are from the University of Oxford/AstraZeneca in the UK, Moderna/NIAID and BioNTech/Fosun Pharma/Pfizer both from the US.

In total, 168 vaccine candidates around the world have started some forms of trials, and 28 of them are in clinical trials, according to the WHO.

There is a higher possibility for China to stand out to be next in vaccine commercialization and the moment won't be too far away, said vaccine experts.

"Given the current progress of China's vaccine research, the country has basically been equipped with the conditions to commercialize the product since the phase-3 trial has to some extent marked the maturity of the technology," Yang Zhanqiu, deputy director of the pathogen biology department at Wuhan University, told the Global Times Wednesday.

"A Chinese-developed vaccine will probably enter the market by the year's end ahead of schedule," Tian Hongjian, a director with the China Medicinal Biotech Association, told the Global Times on Wednesday.

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A staff member takes out samples of the COVID-19 inactivated vaccine at a vaccine production plant of China National Pharmaceutical Group (Sinopharm) in Beijing, capital of China, April 11, 2020. (Xinhua/Zhang Yuwei)

According to China's Ministry of Industry and Information Technology (MIIT), a total of 13 enterprises in China have launched construction of assembly lines to produce COVID-19 vaccines as of July 23, while nine Chinese enterprises have received regulatory approval to start clinical vaccine trials.

Despite understanding Russia's consideration of a short-cut for the approval of the vaccine, Chinese experts noted that it is unlikely Chinese companies would follow Russia's process as China has effectively put the domestic epidemic under control, allowing sufficient time to ensure safety and efficacy.

Our production facilities are prepared to wait for the last-phase clinical trial results and government approval before mass production, the Global Times learned on Wednesday from China National Biotec Group (CNBG), which announced earlier this month that an inactivated COVID-19 vaccine production workshop of its affiliated Beijing institute of biological products, the first and largest of its kind in the world, has passed national examination.

The workshop is estimated to produce 110 million doses per year while another shop of the CNBG in Wuhan could produce 100 million doses.

US drug maker Pfizer and its German partner BioNTech have also announced to eye marketing of their vaccine candidate by October.

Another candidate developed by US drug maker Moderna is also estimated to come into use by the end of this year with the yearly production estimated to reach 500 million doses and possibly 1 billion doses in 2021.

Pre-divided market

Competition on the COVID-19 market started long ago at the beginning of the R&D stage as any contribution to investment basically all come with distribution commitments attached.

Countries with low developing or economic capacities are also trying to ensure more provisions by engaging in the clinical trials.

In addition to its heavy investment in developing the COVID-19 vaccine, the Chinese government said in June that it will make a contribution of $20 million to GAVI's funding for the 2021-25 period.

Two Chinese firms, CanSino Biologics Inc and Walvax Biotechnology Co, and US' Johnson & Johnson have signed deals with Mexico to conduct late-stage clinical trials for COVID-19 vaccines, the Ministry of Foreign Affairs of Mexico said on Tuesday.

Beijing-based Sinovac Life Sciences Corp has also launched clinical trials in Brazil and Indonesia as of Wednesday.

For a future vaccine, experts said that Chinese-developed vaccines will be mainly purchased by Asian countries and some Latin American countries that depend on similar coronavirus genome sequencing or have been cooperating with China on vaccine R&D like Brazil and Mexico.

2a8a6fd3-d6cb-48ad-b02b-f2b52028b0d0.jpeg
A poster reading "This summer I wear a mask when I go out" is seen in Clichy, next to Paris, France, Aug. 4, 2020. Amid signs of the epidemic resurgence, Paris is considering ordering people to wear masks in busy outdoor public spaces after the government authorized local authorities to toughen rule to contain coronavirus circulation during summer holidays. Parisians and visitors will have to wear a mask when they stroll along the banks of the Seine, visit the capital's open-air markets or main tourist spots. (Xinhua/Gao Jing)

Russia did not reveal the 20 countries which have ordered its vaccine, experts estimate that they may mostly comprise of Central Asian and Middle Eastern countries.

Candidates made in the US, UK and Germany, according to an AFP tally, have mostly been ordered by European countries, the US and Japan.

"For countries with their own ability in R&D and production, they are unlikely to purchase imports on a large scale given the vaccine's applicability locally," said Tian.

The demand for a COVID-19 vaccine among China's 1.4 billion population is forecast to reach 1.68 billion to 2.24 billion shots based on a vaccination rate of 60-80 percent and each person needs to have two shots, according to an industry report by Essence Securities.

Compared with the foreseeable handsome returns once the vaccine is put onto the market, previous investment is not that huge, according to Yang.

Assuming that the average purchase and storage price of the vaccine is 20 yuan ($2.88) per shot, then the domestic market space is 33.6-44.8 billion yuan, if calculated at a net interest rate of 50 percent, the corresponding profit margin is 16.8-22.4 billion yuan, said the report.

The space of Chinese-made vaccines in the overseas market is estimated to be within a profit margin of 5-7.5 billion yuan under the prediction that these vaccines would be mainly exported to low-income countries, according to the report.
 
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Tjese numbnut commies need to be held accountable.

All vaccines produced in china need to go to europe and americas first, we can just pay ccp to work for us as usual.
 
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these vaccines will not work and are only made to earn money and for obtaining greater new world order objectives as majority of people recover on their own and this virus is not much lethal like congo virus which vaccination never happened on mass scale but people are surviving without vaccines of congo virus
 
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