Today (november 20th), the Joint Prevention and Control Mechanism of the Chinese State Council held a press conference. Relevant authorities from the Ministry of Foreign Affairs, Ministry of Science and Technology, National Health Commission, State Food and Drug Administration (SFDA), Sinopharm and Sinovac Biotech, and experts attended the press conference to introduce the situation of the COVID-19 vaccine.
Four COVID-19 vaccines entered Phase III clinical trials, with a total of 60,000 subjects vaccinated.
According to Tian Baoguo, Deputy Director of the Department of Social Development Science and Technology of the Chinese Ministry of Science and Technology, 13 vaccines have entered the clinical phase, including inactivated vaccines and adenovirus vector vaccines, a total of four vaccines from two technical routes have entered the Phase III clinical trial, and four vaccines have entered the Phase III clinical trial, and the overall progress has been smooth.
The results of phase III clinical trials are internationally recognized indicators of vaccine protection, but with the COVID-19 pandemic under effective control in China and the conditions for conducting phase III clinical trials not present, the main problems in conducting phase III clinical trials are how to choose the right region and population to be vaccinated and how to organize and implement phase III clinical trials smoothly.
No serious adverse reactions reported for vaccines entering Phase III clinical trials
Mr. Tian Baoguo, said that from Phase I to Phase III, the Chinese vaccine has undergone clinical trials in human vaccination and some mild adverse reactions have occurred, including local pain, swelling and redness, and transient low fever and fever. As a brand-new vaccine, COVID-19 vaccine has been subjected to adverse reaction monitoring as an important indicator of safety throughout the trial process, both by the regulatory authorities and the research team. On the whole, the few vaccines that have entered phase III clinical trials in China are basically mild adverse reactions, and no serious adverse reactions have been reported yet.
Pressenza: Has the new coronavirus mutated?
According to Tian Baoguo, nearly 15 genome sequences of the new coronavirus have been collected in a global database covering 113 countries on six continents, and a comparative study of more than 80,000 high-quality viral gene sequences shows that the virus has mutations, but the mutations are not large and belong to the normal range of mutation accumulation, which has no substantial impact on vaccine research and development.
Pressenza: When will the China-developed COVID-19 vaccine be available?
Wang Tao, chief reviewer of the SFDA’s Drug Review Center, said that the development of vaccines is limited by many factors, such as sample size and the speed of subject enrollment, but once sufficient clinical data are obtained from clinical trials to prove that the vaccine is sufficiently protective and has an acceptable safety profile, the applicant can submit a marketing application if its quality meets the requirements.
The SFDA will follow the law and take special measures to complete the approval of the vaccine as soon as possible to ensure supply.
China’s vaccine production capacity is expected to reach 610 million doses by the end of this year.
Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission, said that the production capacity of China’s vaccine is expected to reach 610 million doses by the end of this year, and the annual production capacity of China’s COVID-19 vaccine will be effectively expanded next year to meet the demand for China’s vaccine from China and other countries around the world. High-risk and high-risk groups will be given priority for vaccination.
Zheng Zhongwei, said, “We have divided the future vaccination populations for the COVID-19 vaccine into three categories. The first group is called high-risk population, the second group is called high-risk likely population, and the third group is called general population”.
“The so-called high-risk groups mainly refer to front-line medical and epidemic prevention staff, border crossing staff, and staff who have to go to highly contaminated areas or countries for work reasons, as well as those who have to ensure the basic operation of cities. High-risk likely groups mainly refer to the elderly, children, pregnant women, and people with underlying diseases, who, once infected with the new crown, have a much higher proportion of severe or critical illnesses than other groups. No matter what region, as long as the vaccine meets the characteristics of these groups, it is our priority to vaccinate them”.
The price of the neocrown vaccine must be acceptable to the people.
Zheng Zhongwei, explained that the price of China’s COVID-19 vaccine will first adhere to the main enterprise pricing, but we must adhere to several basic principles. The first principle is the principle of public product attributes. As a public product attribute, its pricing must not be based on supply and demand, but on cost. The second principle is that the pricing of the COVID-19 vaccine should be based on the public’s willingness and demand for the vaccine. Therefore, I can tell you responsibly that the pricing of the COVID-19 vaccine in China must be within the acceptable range of the general public.
China’s promotion of the emergency use of the COVID-19 vaccine has been rigorously tested and no serious adverse reactions have occurred.
Zheng Zhongwei, said that the COVID-19 pneumonia epidemic is a global pandemic of infectious diseases of the century. Even today, the global pandemic has not been effectively contained. For China, there is tremendous pressure on the import of new coronary epidemics. Beijing, Heilongjiang, Xinjiang, Dalian and Qingdao have also seen small-scale clusters of epidemics, indicating that some domestic rebound pressure is still enormous. Some groups of people in China have become high-risk exposed groups in the course of fighting the pandemic and are at great risk of COVID-19 epidemic infection. Therefore, the emergency use of the vaccine among these populations is a very necessary means to protect their lives and health.
The emergency use of COVID-19 vaccine in China was initiated in strict accordance with the relevant provisions of the Vaccine Administration Law of the People’s Republic of China and the Drug Administration Law of the People’s Republic of China, and has undergone strict demonstration and approval at various levels, and also met the relevant rules of the World Health Organization. After obtaining the approval for the emergency use of the COVID-19 vaccine in China, China also notified the WHO representative office in China, and received their recognition and support.
In the process of promoting the emergency use of the vaccine in China, a very strict expert demonstration was conducted and the emergency use vaccine was preferred. The implementation was organized in strict accordance with the approved protocol on the premise of voluntary, informed and consenting, and a very strict program of screening of vaccine recipients, monitoring and emergency treatment of adverse reactions, and post-vaccination follow-up was established. So far, no serious adverse reactions have been reported in all personnel during the emergency use of the Neocrown vaccine in China, and no infections have been reported in some of the people who went to work in high-risk areas.
Pressenza: In relation to the other countries that are developing vaccines, what attitude has China taken?
Mr. Xing Zhao, Second Inspector of the Department of International Affairs of the Chinese Ministry of Foreign Affairs, said that although China’s research and development of the vaccine remains a global leader and we have sufficient production capacity, we decided to join the implementation program of the COVID-19 vaccine co-sponsored by WHO and the Global Alliance for Vaccine Immunization (GAVI), with the main goal of promoting equitable distribution of the vaccine worldwide and ensuring access to the vaccine for developing countries. In addition, through China’s participation, we also want to encourage other countries with the capacity to do so to join the implementation program.
As a next step, we will use the implementation program as a platform to strengthen cooperation with other countries and international organizations. We also support the participation of Chinese vaccine companies in the implementation program and work with the sponsors of the program to provide vaccines to developing countries.