As of June 10, Beijing time, there were more than 7 million confirmed cases of COVID-19 worldwide.
So far, there is no specific drug to treat COVID-19. The early development of a vaccine to prevent and control COVID-19 has become the common aspiration of scientists and engineers around the world.
Vaccines are the key to the global fight against coVID-19.
What progress has been made in the development of Novel Coronavirus vaccine in China?
When will the vaccine be available?
Can China’s vaccine production meet demand?
This reporter interviewed relevant expert.
“We’re not slow at all.”
Results of the Novel Coronavirus inactivated vaccine study, published online May 6 in Science, show that novel Coronavirus inactivated vaccine is safe and effective in rhesus monkey models, the world’s first novel coronavirus inactivated vaccine study in animals.
After the company had been carried out in China stage Ⅰ Ⅱ and clinical research.
Ⅰ period clinical research on April 16, the purpose is to evaluate the safety of the vaccine, tolerance, and preliminary immunogenicity.
In Ⅰ period clinical after preliminary observation on the safety of the vaccine, Ⅱ period clinical research has been started in early may.
Ⅱ period clinical research to a wider range of the crowd assess the safety and immunogenicity of the vaccine, to determine the dose of the vaccine and immunization programs.
Biological institute of biological products in Beijing, China, the Chinese center for disease control and prevention, Chinese academy of medical sciences and other units cooperation, national Ministry of Science and Technology “863 plan” vaccine special chief scientist Yang xm, maike, yun-tao zhang jointly published online in the cell, such as research papers, to show the world the new champions league progress in vaccine development: the vaccine in mice, rats, guinea pigs, rabbits, and nonhuman primates eat crab rhesus monkeys and monkey () in the induction of high levels of neutralizing antibody, can provide protection against SARS – CoV – 2.
The five main coVID-19 vaccine design routes are: nucleic acid vaccine (including mRNA vaccine, DNA vaccine), recombinant genetic engineering (protein recombinant) vaccine, inactivated vaccine, attenuated influenza virus vector vaccine and adenovirus vector vaccine.
According to data released by the World Health Organization, more than 120 vaccine candidates are under development worldwide, and a small number of them are undergoing clinical trials in humans.
“So far, we have five vaccines in phase II clinical trials, and we are not slow at all,” Zhong Nanshan, an academician at the Chinese Academy of Engineering, said in a recent interview.
“Quality standards will not be lowered because of the short cycle”
“China’s coVID-19 vaccine development will not lower quality standards due to the short cycle.”
Yang Xiaoming, chief scientist of the 863 vaccine plan of the Ministry of Science and Technology and chairman of Sinopac, said that in the process of designing the quality standard of the novel coronavirus vaccine process, it strictly followed the state’s strict requirements on the safety indexes of the vaccine, and did not reduce the testing items and quality indexes due to the shortage of time.
It is essential to ensure the safety of vaccine research and development that all links related to vaccine quality are not reduced or omitted.
At a press conference under the joint prevention and control mechanism of the State Council, Wang Junzhi, an academician of the Chinese Academy of Engineering, also said that vaccines are special medicines for healthy people and safety is the first priority.
This is a significant step forward from the completion of pre-clinical studies to the introduction of vaccines into clinical trials.
The evaluation criteria for safety and efficacy of the vaccine will not be lowered throughout the review process.
At present, the public is highly concerned about vaccines and hopes to see important breakthroughs in China’s vaccine research and development as soon as possible, so that safe and effective vaccines can be marketed at an early date.
“Phase III clinical trials are needed to really determine the efficacy of the vaccine. Phase III clinical trials require a larger sample size. For infectious diseases in general, you look at an epidemic cycle to determine the rate of protection in susceptible populations.
We will have to wait until the end of phase III clinical trials before we have the scientific basis for approval.”
Wang Junzhi said.
“For China and the world
Contribution to the COVID-19 response”
China has made a breakthrough in vaccine research and development. Once the research and development is successful, will the production be able to meet the demand?
Reporter learns biological Beijing institute of biological products from China, as a new crown inactivated vaccines currently the world’s largest production workshop, the relevant state ministries and the support from the Beijing municipal government, Beijing institute of biological products in just two months, on April 15 had completed the construction of the workshop, after preliminary assessment, national biological safety experts and construction standards and quality meet the requirement of biological safety, and created a new crown inactivated vaccine workshop construction “fire mountain”.
According to reports, the workshop batch production of more than 3 million doses, post-production capacity of 100 million to 120 million doses.
In addition, the construction of the coVID-19 inactivated vaccine workshop at the Wuhan Institute of Biological Products is expected to be completed in late June or early July.
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.
The establishment of the workshop for the production of inactivated coVID-19 vaccine fills the biosafety gap in the field of vaccine prevention and control of major emerging infectious diseases in China, and is of great significance to the research, development and production of drugs and vaccines for COVID-19.
“At present, Kexingzhongwei is building a new coVID-19 vaccine production workshop in Daxing District, Beijing. The new vaccine industrialization project launched in Beijing Daxing Base will strongly support kexingzhongwei in the industrialization of new vaccine varieties. It is expected to supply 100 million doses of COVID-19 vaccine every year after production.
We are and the world health organization (who) and the relevant national regulatory agencies, partners to discuss Ⅲ period clinical research plan, hope on a global scale to promote further research and application of vaccine as soon as possible, as soon as possible to play the role of vaccine in disease control, for China and even global COVID – 19 outbreak.”
Sinovac holdings chairman Yin Weidong said.