(From Health Times) On January 28, 2020, the company approved the project, obtained clinical approval in 76 days, approved emergency use in 153 days, completed the construction of the first phase of the plant in 99 days, obtained the production license in 169 days, obtained the conditional listing approval in 374 days, completed the annual production capacity construction of more than 2 billion doses in 1 year, and achieved a global supply of more than 2.7 billion doses... In the past two years, China Kexing has created an impressive vaccine speed with the support of the state in all aspects.
The Chinese government assists Cambodia's Koxing COVID-19 vaccine. Pictured from Xinhua News Agency
The vaccine is clinically available for three months
"Vaccination is the most economical and effective means of preventing and controlling infectious diseases, and it is the basic logic of epidemic prevention and control to do vaccines without vaccines." Yin Weidong, chairman, president and CEO of the company, told the Health Times reporter that in the face of the new crown epidemic that had just emerged at that time, he immediately made up his mind: to start the research of the new crown vaccine and ensure that the vaccine was put out for clinical trials in April 2020.
Obtaining the virus is the key and premise of the research and development of the new crown inactivated vaccine, and if you want the source of the virus, you must have a P3 laboratory, which has become the first problem facing the research and development of kexing vaccines.
In order to achieve the goal of quickly organizing and mobilizing the country's superior forces to achieve specific scientific and technological innovations in the state of emergency, the joint prevention and control mechanism of the State Council has set up a special vaccine research and development class, which is composed of the Health Commission, the Ministry of Science and Technology, the Drug Administration and other departments, effectively linking government departments, medical and health institutions, scientific research institutes, enterprises and other forces, aiming to respect the law of vaccine research and development, and to accelerate the realization of strain isolation, vaccine preparation, animal testing, clinical research and other work to the greatest extent.
On January 28, 2020, China Kexing's "Keguan Action" was officially approved to fully launch the new crown inactivated vaccine development project; on January 30, the first scientific research team of China Kexing entered the P3 laboratory of zhejiang Provincial Center for Disease Control and Prevention; on February 23, it was proved that virus inactivation and purification can stimulate animals to produce neutralizing antibodies; on March 3, animal effectiveness experiments began; at the end of March, animal attack and protection tests began; on April 13, it was approved to enter clinical research; on May 6, in Science, The magazine publishes the scientific results of the world's first COVID-19 vaccine that can enable rhesus monkeys to resist the new crown virus...
The purpose of COVID-19 vaccine research is not only to do scientific research, but more importantly, to control the epidemic. If we develop first, wait for approval and re-production like the previous path of vaccine research and development, it will obviously not catch up with the needs of epidemic prevention and control.
Under the impetus of the "research and review linkage" working mechanism of the "Special Review Work Plan for Anti-novel Coronavirus Drugs" of the Drug Review Center, the research and registration procedures of the new crown vaccine have been promoted simultaneously, from the past "tandem" to "parallel", and to ensure that the procedures are not reduced, the standards are not lowered or even higher than in the past.
In the 34 days from March 16 to April 20, 2020, around the application for clinical research on the new crown vaccine, Kexing has undergone 18 rounds of pre-review, 7 registration inspections, and a total of 7 samplings, a total of 10 batches of stock solutions and 17 batches of finished products. Samples are tested on average every 2 days.
On April 16, 2020, the phase I clinical study of Kerraf, an inactivated vaccine for the new coronavirus at Kerrease, was officially launched.
Monica Calassans, Brazil's first COVID-19 vaccinator, received the Chinese COVID-19 vaccine, Kirraf, at the University Of São Paulo Clinical Hospital. Pictured from Xinhua News Agency
"China Solution" combining production, education and research
With the successful completion of Phase I/II clinical trials, vaccine research and development has encountered new difficulties - where do Phase III clinical research volunteers come from?
According to the data released by the National Health Commission at that time, as of April 8, 2020, there were 1160 cumulative confirmed cases nationwide, and one case was admitted and treated when one case was found, and there was no natural epidemic of the disease. Phase III clinical needs to recruit tens of thousands of volunteers in epidemic situations.
If large-scale phase III clinical research is carried out overseas, according to the cost of tens of thousands of yuan per subject, the clinical trial of the three centers will need at least nearly 1 billion yuan, while the total assets of Kexing Zhongwei, the team responsible for the development of the new crown vaccine under China Kexing at that time, was only 50 million yuan.
"Vaccines for clinical!" Yin Weidong explained, "That is to say, I give the vaccine to my partners, they come to do clinical work, and finally if it is successful, the company will give priority to providing them with vaccines at a price significantly below the market level to achieve risk compensation." ”
In view of how to choose a phase III clinical cooperation country, Yin Weidong put forward four principles: a large population, a serious epidemic situation, no vaccine research and development or production capacity, and better vaccine review and approval capabilities. Based on the above principles, Coxing has set its sights on Brazil, Indonesia, Turkey and Chile, and began to start overseas clinical research in July 2020.
Yin Weidong said frankly that the smooth progress of clinical research in many overseas countries has benefited from the close exchanges and cooperation between governments and China, which has rapidly promoted scientific understanding and cooperation between China and all parties, and greatly promoted the mutual recognition of scientific results between countries and countries. "This is an effect that is difficult for enterprises and individuals to achieve, which is not only a new business cooperation model, but also a strategic cooperation in scientific research." Moreover, these countries have greatly driven the surrounding areas and have rapidly expanded the cooperation of Chinese vaccines in South America and Southeast Asia. ”
At a Fa Ma bottling plant on the outskirts of Kuala Lumpur, Malaysia, a worker packs locally bottling the production of Koxing vaccines. Pictured from Xinhua News Agency
At the same time, Kexing has also begun the industrialization layout of new crown vaccines in China. "If you want to control the epidemic through vaccines, you must make everyone vaccinated, 1.4 billion Chinese one dose, that is, 1.4 billion doses, one person two doses, that is, 2.8 billion doses, not to mention, the new crown vaccine is not only for the Chinese people, but for the whole world." Yin Weidong said.
In order to achieve an annual production capacity of 2-3 billion pieces and ensure the domestic need for vaccines for new crown prevention and control and external supply, Kexing Company has invested more than 4 billion yuan to build a new crown vaccine production line and a off-site entrusted production line.
"There are no orders, I don't know exactly how many vaccines are needed, but Coxing has made the decision to produce 2 billion doses per year. We know that this capacity is absolutely excessive after the normalization of the epidemic in the future, but now the country needs it, and it must be done. The risk of overcapacity I can quantify, but the country needs a vaccine does not, and this risk cannot be quantified. The key moment is to have enterprises make up for the risks that may exist under short-term uncertainty through innovation and courage to invest. Yin Weidong said.
On February 5, 2021, the State Food and Drug Administration approved the inactivated vaccine "Kerrafu" for the inactivated new coronavirus in China. On 1 June 2021, WHO included china's Kexing COVID-19 vaccine in the "Emergency Use List". In addition, the Kexing covid-19 vaccine has also obtained access permits from 58 countries, organizations and regions, including China.
On July 16, 2021, Tian Yulong, chief engineer and spokesman of the Ministry of Industry and Information Technology of China, introduced the production and supply of vaccines in China, saying that as of July, China's annual production capacity of new crown vaccines reached 5 billion doses, effectively ensuring domestic vaccination demand.
As of January 29, 2022, China Kexing's global shipments of COVID-19 vaccine reached 2.7 billion doses, with a maximum single-day shipment of 37.22 million doses, covering 2.052 billion people in 52 countries and regions around the world.
"The new crown vaccine is a typical case of the Chinese program born of the synergy of vaccine research and development and industrialization system with enterprises as the main body and the combination of production, education and research." Yin Weidong said in an interview with the Health Times reporter.
Covid-19 vaccines are being developed for the world
Looking back on the work in the past two years, Yin Weidong said, "Tired is really tired, but the gains in scientific research and industrialization are also huge. ”
On February 15, two of the latest blockbuster papers on Vaccines in China were published on the same day in the sub-journal Of Cell and the Lancet preprint website, and the data based on scientific research in the papers show that Chinese vaccines have played an important role in blocking the COVID-19 pandemic and will continue to play their due role in responding to virus mutations.
In Yin Weidong's view, in the future, the new crown epidemic will tend to normalize, and the vaccination of new crown vaccines will also tend to be normalized. "The COVID-19 pandemic has made us realize that in the future, China should seek more cooperation with more countries in the prevention and control of infectious diseases."
On February 23, Ecuador's Ministry of Health signed a letter of intent with Coxing of China, in which the two sides agreed to build a factory in Ecuador to produce COVID-19 vaccines and other vaccines.
In the past year or so, China Kexing has successively helped partners in Africa, Asia, Latin America and other countries to achieve the localization of the new crown vaccine, and through international cooperation, truly make the new crown vaccine more accessible in the world.
Coshing COVID-19 vaccines Egypt plant. Pictured from Xinhua News Agency
Entrusted by the Ministry of Science and Technology of the People's Republic of China, Kexing Zhongwei undertook the construction of the BRICS Vaccine R&D China Center. The center will promote the joint research and development and trial of vaccines in the five countries, cooperative factory construction, authorized production, and mutual recognition of standards through a combination of online and offline methods.
In the next step, the center will unite brics countries and more countries, cooperate with universities, scientific research institutions, health and disease control institutions and industry in various countries to monitor disease epidemic changes and virus mutations, promote vaccine research and industrialization, explore vaccine application strategies, fund relevant institutions to carry out research on new crown vaccines, and issue invitations to outstanding scientists around the world to join the research team.
Yin Weidong said, "Once the problem of infectious diseases arises, it is not a problem of one country or one region, but a problem of the whole world." Chinese enterprises go overseas to invest and build factories, and at the same time assume the responsibility of maintaining close cooperation with government agencies and scientific research institutions in relevant countries, understanding and obtaining the disease and epidemic situation in these countries at the first time, and cooperating in the development of relevant vaccines, while supporting them, but also achieving the goal of protecting ourselves. ”