China's path to new crown vaccine development
On September 25, the State Council Information Office held a briefing to introduce the development of the new crown vaccine.
Wu Yuanbin, director of the Department of Science and Technology for Social Development of the Ministry of Science and Technology, revealed at the meeting that my country's four new crown vaccines that have entered phase III clinical trials are currently progressing smoothly.
Earlier, WHO Chief Scientist Sumia Swaminathan said that China’s new crown vaccine research and development project is very active, and several candidate vaccines are in the leading stage of clinical trials, and some vaccines have been proven in clinical trials at this stage. effective.
Vaccines are one of the most important scientific weapons for epidemic prevention and control.
At a time when the indicators of the new crown epidemic are on the rise and many governments are forced to tighten epidemic prevention and control measures, the good news of China's new crown vaccine research and development project undoubtedly brings new hope to people.
4 vaccines have achieved good results in phase III clinical trials
“The fastest way to end the new crown pneumonia pandemic and accelerate the recovery of the global economy is to ensure that all countries have people vaccinated against the new crown pneumonia." On September 21, WHO Director-General Tedros Adhanom Ghebreyesus at the new crown pneumonia routine press conference On said.
According to WHO data, there are currently 182 candidate vaccines for new coronary pneumonia virus, 36 clinical trials, 146 preclinical studies, and 9 vaccines have entered phase III clinical trials.
"Currently, 11 vaccines in China have entered clinical trials, and 4 of them have entered phase III clinical trials." According to Wu Yuanbin, 4 vaccines have entered phase III clinical trials, of which 3 are inactivated vaccines and 1 is adenovirus. Vector vaccine.
Recombinant protein vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines are rushing to carry out phase I and phase II clinical trials.
Since the outbreak of the epidemic, Chinese scientific and technological circles and scientific researchers have devoted themselves to scientific research on epidemic prevention and control.
At the beginning of the epidemic, the Chinese government established a multi-departmental and cross-departmental coordination mechanism, adhered to the combination of scientific research and clinical treatment, quickly screened and evaluated a batch of effective therapeutic drugs and treatment methods, and completed nucleic acid testing and antibody testing reagents in a short time. Research and development, in parallel to promote the development of 5 technical routes including inactivated vaccines, adenovirus vector vaccines, recombinant protein vaccines, nucleic acid vaccines, and attenuated influenza vaccines.
Among my country's 4 vaccines that have entered Phase III clinical trials, 2 of them are developed by Sinopharm Group Sino Biotech.
In June, the International Clinical (Phase III) trial of Sinopharm China Bio-New Crown Inactivated Vaccine was officially launched.
Dr. Kabi, one of the main co-investigators participating in the trial in the UAE, said that a total of 31,000 volunteers from 125 countries in the world participated in the clinical trial. The results of the trial showed that all volunteers participating in the trial had developed antibodies.
The new crown vaccine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd., a subsidiary of Kexing Holdings, was approved for emergency use on June 24, 2020.
The vaccine is steadily advancing phase III clinical studies in Brazil, Indonesia, Turkey and other countries.
According to Kexing’s expectations, the company will be able to obtain Phase III research results in November or December.
In August, the recombinant new crown vaccine (Ad5-nCoV) developed by the team of Chen Wei, an academician of the Chinese Academy of Engineering, and Cansino Biological Co., Ltd. began to carry out phase III clinical trials in multiple countries.
Currently, Phase III clinical trials have made preliminary progress in Pakistan, and all subjects in the first group were enrolled and vaccinated.
Countries fiercely compete for vaccine research and development
Internationally, the Russian Ministry of Health registered the world's first new crown vaccine on August 11, which was jointly developed by the Gamallea National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund, and was named "Satellite-V".
Since the vaccine was not approved for Phase III clinical trials, vaccine experts have criticized this move as a risk.
Recently, Günzburg, director of the Russian National Research Center for Epidemiology and Microbiology, said that within the framework of post-registration research, nearly 2500 volunteers in Moscow have been vaccinated with the first vaccine without obvious complications.
According to Reuters, the two leading pharmaceutical companies in the United States, Modena and Pfizer, launched Phase III trials at the end of July, and only half of the originally planned subjects were recruited one month later.
According to Pfizer, the first test data analysis can be completed as soon as October.
The Canadian government has reached a new crown vaccine pre-purchase agreement with four US vaccine manufacturers, Modena, Pfizer Pharmaceuticals, Novavax and Johnson & Johnson, and is negotiating more orders; at the same time, it is funding domestic vaccine research and development that is relatively backward. Project and build a new vaccine production facility in Montreal.
Australian Federal Health Minister Greg Hunt said in an official statement on September 20 that the University of Melbourne will develop a protein vaccine and a messenger ribonucleic acid (mRNA) vaccine.
The University of Sydney will conduct a phase 1/1b clinical trial to test the safety and effectiveness of a deoxyribonucleic acid (DNA) vaccine.
This is a non-injectable new crown vaccine under development.
On August 24, the Italian new crown vaccine project began a phase one clinical trial.
Italy's National Institute of Infectious Diseases Hospital Health Director Francesco Vaya said that if the vaccine trial is successfully completed within the year, it is expected to start production in the spring of 2021.
Many Latin American countries also hope to use vaccines to contain the epidemic.
Cuba launched the first local candidate new crown vaccine clinical trial on August 24, which is the first domestically developed and clinical trial candidate vaccine in Latin America.
Vaccine research and development clinical trials have not been smooth sailing, and there are still many unknown difficulties and obstacles.
According to a British media report on September 9, AstraZeneca suspended the Phase III trial of the new crown vaccine due to adverse reactions among British vaccinators.
Reuters reported that a participant in the trial had an unexplainable neurological disorder.
The company is investigating whether the symptoms are related to the vaccine to confirm the safety of the vaccine.
Currently, AstraZeneca’s trials in the United States are still suspended, but trials in the United Kingdom, Brazil, India and South Africa have resumed.
What impact will the virus mutation have on the vaccine
The new coronavirus is an RNA virus: a collection of genetic material wrapped in a protein shell.
Compared with DNA viruses, such as herpes virus and smallpox virus, RNA viruses are more prone to mutation or mutation.
The Ekman Institute of Molecular Biology in Jakarta, Indonesia, recently stated that a mutant strain of the new coronavirus code-named D614G was found in the genome sequencing data. The mutant strain is more infectious than the original strain.
Amin Soebandrio, director of the Aikman Institute of Molecular Biology, pointed out that he found 8 D614G variant strains in the 22 genome sequencing notified by the Indonesian government. Although the researchers have not yet calculated the percentage of patients with variant strains in China, But it believes that the mutant strain has now been transmitted to most patients in the country.
What impact will the mutation of the new coronavirus have on the vaccine?
Academician Chen Wei gave answers at the Global Science, Life and Health Forum held on September 18.
Chen Wei mentioned that as of September 2020, more than 100,000 viral sequences have been uploaded to public databases, of which about 60,000 high-quality whole-genome sequences were sampled from more than 105 countries and regions on 6 continents.
The study found that the current virus mutation site that has attracted much attention is D614G, which is located in the B antigen cell region. According to homology modeling, the mutation has little effect on the structure of this region.
At the same time, the distance between D614G and the receptor binding domain (RBD) is relatively long, and the impact on antigenicity is limited, so the impact of this mutation on the vaccine is very small, "minimal."
"What we have developed is a genetically engineered vaccine, which is to find the most useful gene and make it into a vaccine. From the current data analysis, the chance of a change in the gene we selected is very small. Up to now, our recombination The new coronavirus vaccine can completely cover the new coronavirus that has mutated." Academician Chen Wei pointed out that the recombinant new coronavirus vaccine can effectively cover the virus mutation. In addition, once the virus mutates and affects the protective effect of the vaccine, the current vaccine can be used as the basic immunity Soon, a more targeted vaccine will be made to boost immunity to it, "just like patching a software upgrade."
According to Dr. Benjamin Neuman, head of the Department of Biological Sciences at Texas A&M University, the chance of RNA viruses mutating and becoming more aggressive is very small, and viruses are more likely to mutate into weaker versions.
In fact, this slow and gentle mutation is good news.
"The virus is still very similar to the original sequence, so there is not much reason to think it will affect the vaccine."
When can ordinary people use the vaccine
The current new crown pneumonia epidemic is still spreading globally and has not yet been fully controlled. With the arrival of this autumn and winter, there is still the possibility of a rebound, and the epidemic prevention and control situation is still severe.
When ordinary people can use the vaccine is a question of concern to many people.
According to Yang Sheng, the head of the Drug Registration Management Department of the State Food and Drug Administration, pre-clinical research, phase I and phase II clinical studies must be completed before the vaccine is marketed, and phase III clinical trials must be passed to prove that the safety and effectiveness of the vaccine have reached the design level. Set standards.
In addition, commercial scale verification must be completed to prove the acceptable safety, clear effectiveness and quality controllability of the proposed vaccine.
The progress of Phase III clinical trials is affected by many factors, such as the number of subjects, the number of subject groups, and the results.
Researchers will go all out to race against time to promote my country's new crown vaccine as soon as possible.
On September 17, Ali Health and Kexing Holding Biotechnology Co., Ltd. signed an agreement under which the two parties will jointly build a new crown vaccine vaccination platform.
The platform will include several functions such as online appointment for the new crown vaccine, matching of vaccine information based on Ali's health traceability code, follow-up of health status after vaccination, and issuance of vaccination certificates.
At present, some people with high risk exposure have been able to make appointments and follow-up services for the new crown vaccine through this platform.
On September 24, the 13th China Biological Industry Conference was held in Wuhan.
Yang Xiaoming, chairman of Sinopharm Group China Biotech, said that the current trial progress of the new crown inactivated vaccine is better than expected, faster than expected, and "one kilometer" away from the final success. It is expected to be launched by the end of 2020.
How long will the vaccine last?
According to the results of phase I and phase II clinical trials that have ended, a variety of new crown vaccines show good safety and also show the effectiveness of antibodies.
How long can these antibodies last?
According to the "Guidelines for Clinical Evaluation of New Coronavirus Vaccines (Trial)" issued by the Drug Evaluation Center of the State Drug Administration recently, the effectiveness of the new coronavirus vaccine is specifically proposed: The vaccine should provide protection for 1 year or more, at least Provide 6 months of protection.
Zeng Guang, chief epidemiologist of the Chinese Center for Disease Control and Prevention, said that the time for humans to discover the new coronavirus is only 9 months, and how long each vaccine will protect after vaccination requires long-term and a large amount of research work.
The current positive result is that the serum monitoring results of the subjects who were first vaccinated in my country show that the antibody still maintains a high level, which suggests that the vaccine may have a longer-term protective effect.
Zhou Song, secretary of the China Biological Disciplinary Committee and general counsel of Sinopharm Group, told reporters that based on the combination of animal experiments, phased research results, and previous similar technology platform vaccines, the durability of vaccine immunity and the protective effect will be maintained for 1 to 3 years. The above possibilities are high and are effective against known mutant viruses.
After the vaccine is marketed, the general population can be vaccinated. In the current state of emergency use, it is recommended that women during pregnancy and breastfeeding be delayed for vaccination.
Regarding the public concern about the price of the new crown vaccine after its launch, Zheng Zhongwei, the leader of the research team’s vaccine research and development team, believes that the public product attribute of the new crown vaccine is the basic compliance with its pricing. Since it is a public product, it must be satisfied. Accessibility and affordability.
After the official launch, the new crown vaccine will be adjusted in price according to other factors such as technical route and scale of use.
"But in any case, we must make the new crown vaccine accessible and affordable, and we will definitely propose a guide price within the range acceptable to the public." Zheng Zhongwei said.
Domestic vaccine production capacity will reach more than one billion doses by 2021
Ryan, the head of the WHO health emergency project, said recently: “When vaccines are proven to work, the challenge is whether there is enough production to supply the world.” According to the Gates Foundation’s estimates, to achieve global immunization, according to Two vaccines per person require at least 10 billion doses of the new crown vaccine.
To truly control the epidemic, safe, effective, and sufficient vaccines are needed.
At present, will domestic vaccine production be rolled out soon? Can domestic supply be guaranteed?
According to Zheng Zhongwei, according to estimates, the annual production capacity of my country's new crown vaccine is expected to reach 610 million doses by the end of this year, and it will reach more than 1 billion doses next year.
In the future, vaccines will be arranged in order according to the three stratifications of high-risk groups, high-risk groups, and general groups.
Among them, high-risk groups include workers at border ports, city operators, and cold by-product production workshop workers; high-risk groups include the elderly, pregnant women, children, and people with underlying diseases.
In June of this year, China Biotech has built the world’s largest COVID-19 vaccine production workshop. It is currently the world’s first COVID-19 vaccine capable of producing 100 million doses per year, and constructed in accordance with biosafety and GMP standards to meet emergency vaccination needs in quantity. The vaccine production workshop has filled the biological safety gap in the vaccine field for the prevention and control of major domestic diseases.
Zhou Song told reporters that Sinopharm Sinopharm has established high-level biosafety production facilities in two biological product research institutes in Beijing and Wuhan, and it is expected that the combined production capacity of the two institutes will reach 300 million doses.
"At present, Sinopharm Group China Biosciences is studying the expansion of production capacity in accordance with the relevant deployment requirements. After the expansion of production capacity in the future, it may reach an annual output of 800 million to 1 billion doses."
"From the current point of view, the goal of producing 300 million yuan a year is achievable, and we are working hard to expand our production capacity. After the phase III test results come out, our production capacity will also keep up with it, and we are ready to inoculate the people on a large scale. , Strive for seamless connection." Chen Wei said.