Five vaccines in my country entered the second phase of clinical trials
As of June 10th, Beijing time, there were more than 7 million confirmed cases of new coronary pneumonia worldwide. So far, there is no special medicine for the treatment of new coronary pneumonia. The early development of a vaccine to prevent and control the new coronary pneumonia has become the common wish of scientific and technological workers in the world.
Vaccines are the key to the global victory over the new coronary pneumonia epidemic. What progress has been made in the development of China's new coronavirus vaccine? When will the vaccine be marketed? Can China's vaccine production meet demand? This reporter interviewed relevant experts.
"Our speed is not slow"
On May 6, the results of the pre-clinical study of Kexing New Crown Vaccine were published online in the journal Science. The results showed that the new inactivated coronavirus vaccine of Kexing Zhongwei was safe and effective in the rhesus monkey model, which is the world’s first Results of animal experiments on the new crown vaccine. The company has previously been approved to conduct Phase I and Phase II clinical studies in China. The Phase I clinical study began on April 16 to evaluate the safety, tolerability and initial immunogenicity of the vaccine. After preliminary observations on the safety of the vaccine in Phase I clinical trials, Phase II clinical studies were initiated in early May. Phase II clinical studies should evaluate the safety and immunogenicity of the vaccine in a larger population to determine the vaccine dosage and immunization schedule.
Recently, China Bio-Beijing Institute of Biological Products, the Chinese Center for Disease Control and Prevention, the Chinese Academy of Medical Sciences and other units cooperated, and Yang Xiaoming, Wang Hui and Zhang Yuntao, chief scientists of the "863 Program" vaccine special project of the Ministry of Science and Technology, jointly published research online in "Cell" The paper introduces the development of the new crown vaccine to the world: the vaccine induces high levels of neutralizing antibodies in mice, rats, guinea pigs, rabbits and non-human primates (cynomolgus monkeys and rhesus monkeys), which can provide targeted SARS-CoV-2 protection.
At present, the main five new crown 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 published by the World Health Organization, there are more than 120 candidate vaccines under development worldwide, and a small number of them have begun clinical trials on human subjects.
Academician Zhong Nanshan of the Chinese Academy of Engineering said in an interview recently: "So far, we have five vaccines in the second phase of clinical trials, and our speed is not slow."
"No reduction in quality standards due to short cycle time"
"China's new crown vaccine research and development will not reduce the quality standards because of the short cycle." Yang Xiaoming, chief scientist of the vaccine special project of the Ministry of Science and Technology 863 plan and chairman of Sinopharm Zhongsheng Group, said that in the process of designing the quality standards of the new crown vaccine process route, it is strictly in accordance with the country. Strict requirements are imposed on the safety of vaccines, and there is no reduction in testing items and quality indicators due to time constraints. All the links related to the quality of the vaccine are not reduced or omitted, which is the first priority for ensuring the safety of vaccine development.
At a press conference held by the Joint Defense and Joint Control Mechanism of the State Council, Wang Junzhi, an academician of the Chinese Academy of Engineering, also said that the vaccine is a special medicine for healthy people, and safety is the first priority. The completion of the vaccine from pre-clinical research to clinical trials is a very important development, and it has taken a big step toward application. Throughout the review process, the evaluation criteria for vaccine safety and effectiveness will not be reduced. At present, society pays close attention to vaccines and looks forward to seeing breakthrough and important progress in vaccine research and development in my country as soon as possible, so that safe and effective vaccines can be launched as soon as possible.
"True confirmation of the effectiveness of the vaccine requires a phase III clinical trial, which requires a larger sample size. For general infectious diseases, it is necessary to observe an epidemic cycle to determine its protection rate for susceptible people. The scale of the trial is several Thousands or even tens of thousands of people. It is not until the third phase of the clinical trial is over that the scientific basis for the vaccine being approved for marketing can be obtained." Wang Junzhi said.
"Contribute to China and even the global response to the new coronary pneumonia epidemic"
my country's vaccine research and development has made breakthrough progress. Once the research and development is successful, production needs to be met, can the output meet the demand? The reporter learned from China Bio Beijing Institute of Biological Products that as the world's largest new crown inactivated vaccine production workshop, with the strong support of relevant national ministries and the Beijing Municipal Government, Beijing Institute of Biological Products only took 2 months to The construction of the workshop was completed on April 15th. After preliminary on-site assessment by national-level biosafety experts, the construction standards and quality levels met the requirements for biosafety protection, creating the "Vulcan Mountain" speed for the construction of the new inactivated vaccine workshop.
According to reports, the batch production in the workshop exceeds 3 million doses, and the annual production capacity will reach 100 million to 120 million doses after mass production. In addition, the construction of the new crown inactivated vaccine workshop at Wuhan Institute of Biological Products is expected to be completed by the end of June or early July. At that time, the two institutes of China Biology will add up to an annual production capacity of more than 200 million doses to ensure the availability of the new crown inactivated vaccine. The completion of the new crown inactivated vaccine production workshop fills the biosecurity gap in the field of vaccines for the prevention and control of major new and emerging infectious diseases in China.
"At present, Kexing Zhongwei is building a new vaccine production workshop in Daxing District of Beijing. The new vaccine industrialization construction project launched at the Beijing Daxing base will effectively support the industrialization of Kexing Zhongwei's new vaccine varieties under development. 100 million doses of new crown vaccines will be supplied every year. We are also discussing with the World Health Organization and relevant national regulatory agencies and partners on the phase III clinical research plan, hoping to promote the follow-up research and application of vaccines as soon as possible worldwide, and make the vaccines available as soon as possible. The role in disease control will contribute to China and even the global response to the new coronary pneumonia epidemic," said Yin Weidong, chairman of Kexing Holdings.
(Reporter Yuan Yufei)