According to China’s Science and Technology Daily, two COVID-19 inactivated vaccines have been approved for a phase I and II combined clinical trial by the National Medical Products Administration (NMPA) of China, making them the first batch in this category. The two vaccines were developed respectively by Wuhan Institute of Biological Products Co., Ltd. of Sinopharm and Sinovac Research & Development Co., Ltd together with research institutes.
This is another piece of good news since the team of Chen Wei, academician at China Academy of Engineering and researcher at Academy of Military Medical Sciences, managed to get clinical trial approval for the recombinant COVID-19 vaccine they developed on March 17.
“We are taking the lead in developing COVID-19 vaccines in a global perspective,” says Wang Junzhi, academician at China Academy of Engineering. Then he proposed four factors for this achievement: early start, accurate direction, being science-based, and collaboration from all parts. According to the scientists, the vaccine is the most powerful weapon to defeat COVID-19.
China made the decision to accelerate the pace based on rational judgement and organization with the premise of safety assurance. As early as January 21, the Ministry of Science and Technology (MOST) announced the establishment of an expert group of joint epidemic prevention and control against COVID-19. The group was led by Zhong Nanshan, academician at China Academy of Engineering, and consisted of 14 experts. On January 22, the first eight emergency programs to address COVID-19 were initiated.
The group decided on five directions for vaccine development: inactivated vaccines, genetic engineering subunit vaccines, adenovirus vector vaccines, nucleic acid vaccines, and vaccines using attenuated influenza virus as vectors. All five directions were to be followed at the same time. Eight teams of advantage in vaccine development were singled out to collaborate on this mission with a detailed plan of work nodes accurate to the day.
Thanks to Chen Wei's accurate judgement and accumulation of knowledge and experience in vaccine development, her team was the first to reach breakthrough achievements. In early February, she suggested that COVID-19 remains a coronavirus despite its possible variation. Therefore, mutual target antigen, pathogenesis, and receptor could be identified quickly with the help of bioinfomatics and big data mining once the variation appears. And the vaccine development can be improved swiftly accordingly.
Since the start of the program, at speed. On March 17, the team’s recombinant COVID-19 vaccine was approved for clinical trial, which took place one month earlier than expected. By April 2, all 108 subjects of phase I clinical trial in Wuhan had been inoculated. On April 9, phase II clinical trial, which has a larger scale and introduces placebo control groups, started recruitment for volunteers.
Lei Chaozi, head of the department of science and technology of the Ministry of Education, noted additional achievements: research on the safety and validity of experimental animal for attenuated influenza vector vaccine is ongoing and preclinical trial research for vaccine candidates and application for clinical trial are expected by the end of April; animal experiments on mice and rabbits regarding recombinant protein vaccine are being conducted and the technology of large-scale production of vaccine with high quality and purity has been mastered; nucleic acid vaccine development is a new technology being explored by the whole world, but no such vaccine has entered the market yet.
At the same time, Wang Junzhi specifically emphasized the safety issue of the vaccine: “On the one hand, Chinese scientists seek to make full use of time with great effort. On the other hand, they conduct research under scientific laws and ensure the safety and validity of the vaccine. All research and development activities are in accordance with corresponding regulations and technological requirements.”