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https://scmp.com/news/china/science/article/3079841/coronavirus-green-light-human-trials-two-more-chinese-vaccine
China/ Science

Coronavirus: green light for human trials on two more Chinese vaccine hopefuls

  • Medical products watchdog gives approval for clinical tests for two experimental preparations, with more expected to follow
  • Study of therapeutic use of plasma from recovered patients also yielding positive early results, official says
China has approved two more experimental coronavirus vaccines for human trials. Photo: Xinhua

China is pressing ahead in the global race to find a vaccine and treatment for the pandemic coronavirus, fast-tracking regulatory approval for a number of clinical trials.

In the last few days, the country’s medical products watchdog has approved human trials for two more experimental vaccines. Trials for another potential vaccine started last week and at least three more are expected to start later this month and in May.

A clinical study on the therapeutic use of plasma from recovered coronavirus patients is also under way after promising early results.

The advances come as the epidemic appears to wane in China.

Authorities reported 89 new Covid-19 cases on Tuesday, all but three of them imported. Another 54 patients tested positive for the virus but had not developed symptoms for the coronavirus, which has killed 3,341 people throughout the country.

In all, 70 potential coronavirus vaccines are in development around the world, with three already being tested on humans, according to the World Health Organisation.

Wu Yuanbin, head of science and technology for social development at the Ministry of Science and Technology, said on Tuesday that approval for clinical testing had been granted to Wuhan Institute of Biological Products, under state-owned China National Pharmaceutical, and Sinovac Research & Development in Beijing.

The two experimental candidates are both inactivated vaccines, or viruses that have been grown in culture without the capacity to induce disease but with the ability to trigger an immune defence against a real infection.

“Such vaccines have a well-developed production process, controllable quality standards, wide protection scope and internationally adopted criteria for safety and effectiveness, which contributed to speeding up the process for the vaccines to be used,” Wu said.

Animal trials are being conducted for vaccine candidates based on three other technologies.

“According to preliminary analysis and arrangement, clinical trials for the vaccines using these technology routes [might begin] in April and May,” Wu said.

It usually takes years to develop a vaccine but the sprint to clinical trials has been accelerated by early involvement of the authorities and a fast-track application process that does not compromise on safety, according to Wang Junzhi, from the Chinese Academy of Engineering.

Wang said various authorities were involved in drawing up guidelines for trials on animals and to assess the quality of vaccine samples.

China has also embarked on a randomised, double-blind, controlled clinical studies on convalescent plasma therapy in Wuhan, the central Chinese city where the coronavirus initially erupted.

Sun Yanrong, deputy head of the China National Centre for Biotechnology Development, said more than 2,000 plasma samples had been collected from recovered coronavirus patients around the country and transfused into 700 patients fighting the virus.

“Preliminary results show that in terms of clinical improvement, the use of convalescent plasma therapy is significantly better than the control group,” Sun said.

“The median ICU hospital stay is also significantly lower than the control group. From this point of view, the convalescent plasma has shown a certain effect in clinical treatment.”

The announcement about the new clinical trials comes just days after another potential vaccine developed by Tianjin-based CanSino Biologics and the Academy of Military Medical Sciences’ Institute of Biotechnology, entered the second phase of human trials.

US biotech start-up Moderna started the world’s first clinical trial in mid-March, and Inovio Pharmaceuticals is partnering with Beijing Advaccine Biotechnology in China for its first human trials

In 2004, Sinovac developed a potential vaccine for severe acute respiratory syndrome, or Sars, a virus that shares about 80 per cent of the gene structure of Sars-Cov-2, the coronavirus that causes the disease Covid-19.

The company completed phase one clinical trials for the vaccine candidate but did not proceed because there was no longer a Sars outbreak in mainland China. The company developed the world’s first H1N1 influenza vaccine in 2009 amid a global pandemic.

Wuhan Institute of Biological Products, a state-owned company, was hit by a scandal in 2018 over the production and sale of substandard diphtheria, whooping cough and tetanus vaccines for children.

In China, vaccine clinical trials are carried out in three phases. The first one involves a small group of volunteers to test whether the candidate is safe and can trigger an immune response, while the second one involves tests on hundreds of people to determine the best vaccination plan. The third phase is to test the vaccine’s safety and effectiveness on a bigger group of people.

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