Zhangyuntao said that the effectiveness of the prototype vaccine in reducing severe cases is still more than 90%, which can greatly reduce the mortality. It has obtained the clinical approval of new drugs in 3 months, listed conditionally in 11 months, supplied to 119 countries and regions around the world, and produced and used more than 3.5 billion doses at home and abroad... These "figures" come from the novel coronavirus pneumonia inactivated vaccine (Vero cells). As the chief scientist of Sinopharm China Biotechnology Co., Ltd., zhangyuntao promoted the generation of these "figures".
A few days ago, the list of "the most beautiful scientific and technological workers" in Beijing in 2022 organized by the Publicity Department of the Beijing Municipal Party committee, the Beijing Association for science and technology and other departments was announced, including Zhang Yuntao. In an interview with the media, he was busy all day talking very fast and could quickly get to the point. Talking about the experience of vaccine research and development, the "vaccine man" who has been deeply involved in the field of biopharmaceutical for 34 years is more willing to talk about the efforts of the team.
Zhangyuntao (right) discusses the R & D plan with the staff in the laboratory. Biological map of China
Research and development of new crown vaccine "from scratch"
At the beginning of 2020, the sudden outbreak of COVID-19. COVID-19 is a disease that the whole population will be infected as a susceptible population. In the face of the severe situation, it is urgent to develop a safe and effective vaccine.
China has laid out five technical routes for vaccine research and development, including virus inactivated vaccine, nucleic acid vaccine, recombinant protein vaccine, adenovirus vector vaccine and attenuated influenza virus vector vaccine. As the vice president of China biology, zhangyuntao has rich experience in R & D. he is well aware that each technical route has its own characteristics. However, after comprehensively considering the four aspects of safety, effectiveness, accessibility and industrialization, he and the R & D team will take the lead in focusing on the most traditional classical technical route of vaccine - virus inactivated vaccine. "China has a large population. We must have our own safe and effective new coronavirus vaccine that can be used on a large scale."
On the second day of the lunar new year, Zhang Yuntao brought the scientific researchers of Beijing Institute of biological products of China biology to the biotechnology development center of the Ministry of science and technology to make a report on the subject of novel coronavirus inactivated vaccine.
Compared with conventional vaccines that have been developed for several years, the research and development of new crown vaccines is facing challenges such as extreme time compression and extreme shortage of experimental animal resources. Zhang Yuntao and his team overcame difficulties and worked day and night to complete the overall design and R & D of the new crown vaccine. On April 12, China's novel coronavirus inactivated vaccine obtained the world's first clinical approval for inactivated vaccine.
In addition, a huge problem is waiting for the R & D team - the industrial production of Xinguan inactivated vaccine, which needs to use a high-level biosafety production workshop that meets the P3 requirements. Previously, there was no P3 workshop that produces human vaccines in China.
"We don't have such production facilities, and the construction standards are blank. What should we do? We make our own standards." Recalling the scene two years ago, zhangyuntao is still very proud. He said that in 60 days, the Beijing Institute of biological products completed the first high-level biosafety workshop for novel coronavirus vaccine in China and the world. "This is a huge innovation. China's biological cooperation departments have prepared the first domestic standards for vaccine biosafety production facilities and biosafety system documents, filling the gap in the hardware standards and management system of China's high-level biosafety workshops for human vaccines. Subsequently, workshops in Wuhan, Changchun and other places have been established in accordance with the standards, so that the new crown vaccine can be produced on a large scale."
On June 30, the relevant national departments included the two inactivated novel coronavirus vaccines developed by China biology into the scope of emergency use.
High standard managers
After the efficient completion of phase I and II clinical trials, Zhang Yuntao began to plan to launch large-scale protective clinical studies overseas. "Due to the well controlled epidemic situation in China and the lack of conditions for protective clinical research, we need to go overseas to carry out phase III protective clinical research."
In july2020, a clinical team of more than 70 Chinese biologics arrived in the UAE. It was the hottest time in the region, and the outdoor temperature in the daytime was as high as 50 ℃. High temperature, unaccustomed to local diet, and poor language... Faced with many difficulties, Zhang Yuntao still required employees to meet the highest standards in order to ensure the standardization and effectiveness of key clinical data.
"The core of protective clinical research is to catch cases, and then analyze whether vaccination can play an effective protective role." Zhangyuntao remembers that one night, the team provided the case data from the UAE to the Chinese endpoint case Determination Committee. The committee is composed of China's top experts. It is an independent third party and has the role of auditing. Despite the great efforts made by all of us, one case even provided one book of information, the committee still believes that it is necessary to continue to supplement the information and data.
"In the past, those foreign clinical colleagues looked down on us. This is the first time that Chinese people have gone abroad on a large scale. We just want to show them that we are no worse than them." That night, zhangyuntao said that all the people who submitted the materials cried. It is not easy for him to sympathize with you, but he must give you some pressure and motivation in the evaluation cycle of racing against the clock. Although the spirit was close to collapse at that time, the overseas clinical team still clenched their teeth and worked hard day and night, and finally successfully passed the review of the national regulatory authorities.
On december30,2020, China's new biological crown inactivated vaccine was approved for conditional marketing, which is the first new crown vaccine approved for marketing in China.
On may7,2021, China's new biological crown vaccine was added to the "emergency use list" (Eul) of who. Behind this is the hard work of zhangyuntao and his team.
"We have been communicating with who since the end of 2020. We have held numerous meetings and submitted numerous materials. They have also come to the site for verification." On the evening of new year's Eve, he led his team to conduct a video defense in the office of China biology. More than 250 who experts raised many sharp questions about the clinical data of vaccines. Zhang Yuntao's well grounded, scientific and rigorous answers won the recognition of who experts.
On May 4, China's Labor Day holiday, Zhang Yuntao stayed up late to watch the mailbox after learning that the who would send an email for supplementary materials on that day. After receiving the e-mail at 3 a.m., he led the international cooperation, clinical research and other team members to an online meeting. After overnight discussion, he answered the who questions at dawn. Three days later, who director general Tan Desai announced that the new crown vaccine developed by the Beijing Institute of biological products of Sinopharm group would be included in the "emergency use list". "This marks that our vaccine technology has been recognized globally."
"If you choose public health, you will not stop fighting"
Vaccines are powerful "weapons" for epidemic prevention and control.
In 1988, after graduating from Lanzhou University, zhangyuntao was assigned to Lanzhou Institute of biological products, which was affiliated to the former Ministry of health, and began to engage in the research and development of biological products such as vaccines. In 2004, he finished his doctoral degree at Lanzhou University. Over the years, as the project leader, he has presided over a number of major national scientific research projects, promoted the listing of more than 30 new biopharmaceutical products, including new crown vaccine, EV71 vaccine, bopv vaccine and SIPV vaccine, and promoted the great leap forward development of Chinese biological products. What has never changed from a scientific and technological worker to a scientific and technological management worker is his determination to overcome difficulties for the needs of the country and the health of the people.
Before participating in the research and development of the new crown vaccine, Zhang Yuntao had had several confrontations with the virus.
In 2008, hand, foot and mouth disease became popular in China. Infants infected with enterovirus EV71 are easy to cause severe cases, with herpes on hands, anus and mouth at the same time. Severe cases need to be rescued in ICU. The project of HFMD vaccine was approved in 2008. Just after Beijing Institute of biological products obtained the virus strain and put it into research and development, it encountered a difficult problem - the selection of animal models.
"Unlike COVID-19, which is prevalent in the whole population, HFMD is prevalent in children under the age of 6. We used adult mice and monkeys to do experiments. They do not get sick. Only suckling mice can get sick." Zhangyuntao explained that usually adult rats need to be inoculated with the second and third injections at a certain interval to complete an immunization program. However, suckling rats are close to maturity before completing an immunization program and will not get sick again.
At that time, zhangyuntao was appointed deputy director of Beijing Institute of biological products. Under his leadership, the R & D personnel made a clever design.
They vaccinated pregnant mother mice so that newborn suckling mice could obtain maternal antibody, and then the suckling mice were tested for challenge. The results showed that the newborn mice of the vaccinated mother mice did not get sick or suffered from severe diseases because of the protection of antibodies. "This proves that EV71 inactivated vaccine is effective."
The inactivated enterovirus 71 (EV71) vaccine developed by Beijing Institute of biological products is the first vaccine used to prevent hand, foot and mouth disease in the world. "After the vaccine was launched in 2017, the incidence rate of hand, foot and mouth disease (HFMD) caused by EV71 in Chinese children has probably decreased by 94%." Zhangyuntao speaks with pride.
At present, the epidemic caused by the Omicron mutant has spread to many places. In the face of its stronger transmission and concealment, Zhang Yuntao once again led the team to "race" against the virus.
He disclosed that the inactivated vaccine of Omicron zhuxinguan virus developed by the Beijing Institute of biological products was undergoing a sequential clinical trial, which was the first clinical study among the people who had been vaccinated with the new coronal vaccine after the vaccine was vaccinated in the blank population in Hangzhou, Zhejiang Province. "According to the data obtained so far, the vaccine can induce high-level neutralizing antibodies against the Omicron variant, and produce high-level neutralizing antibodies against beta and delta strains." He said that if the follow-up is successful, everyone is expected to start vaccination as soon as October this year.
In his view, developing vaccines to defeat infectious diseases is a glorious cause. "If I choose public health as my lifelong career, I will continue to struggle." Zhangyuntao said that the election of the most beautiful scientific and technological worker in Beijing is an affirmation to all Chinese vaccine people, "it will spur us to innovate constantly and provide more 'weapons' to solve the health problems of the people."
■ clarification
1 Is it still necessary to inoculate the prototype vaccine against the Omicron variant
Zhang Yuntao said that studies have proved that the main nucleic acid diagnostic reagents are still effective for the mutated novel coronavirus, but the efficacy of the vaccine has decreased significantly. For Omicron strain, 85% of the therapeutic monoclonal antibodies in the world failed, and the efficacy of the original vaccine decreased by about 80%.
So, is it necessary to vaccinate the previous prototype strain of the new crown vaccine? Zhang Yuntao said that although its efficacy against the Omicron mutant decreased, from the characteristics of the prototype vaccine, its efficacy in reducing severe cases still exceeded 90%, which can greatly reduce the mortality. Therefore, before the vaccine of Omicron strain can be inoculated, it should be received completely. When the Omicron strain vaccine can be inoculated in the future, if the Omicron strain is still an epidemic strain, it is necessary to inoculate the Omicron strain vaccine.
2 In the future, after the launch of Omicron vaccine, do the people who have previously been vaccinated with the new crown inactivated vaccine have to be vaccinated with the vaccine from the original manufacturer
Zhangyuntao said that there is no problem in mixing vaccines of the same technical route. In the future, after the launch of Omicron's new crown inactivated vaccine, the people who had previously been vaccinated with the new crown inactivated vaccine can choose the vaccine produced by different manufacturers.