Taking the Lead in Introducing Genetically Engineered Hepatitis B Vaccine Technology in China, Sticks to Original Aspiration for 33 years
Today is the 12th “World Hepatitis Day” designated by the World Health Organization, which calls foreveryone to be actively vaccinated against hepatitis,and totake the initiative to have a physical examination to keep informed about the liver health status, and for patients with hepatitis are encouraged to receivestandardized antiviral treatment, so as to jointly curb the threat of hepatitis to human health.
Meanwhile, this year is also the 33rd year of BIBP’s introduction of genetically engineered hepatitis B vaccine technology
BIBP’s hepatitis B vaccine has made an indelible contribution to the promotion of hepatitis B immunization in China.
From 1992 to 1995, a nationwide seroepidemiological survey of viral hepatitis showed that 690 million people had been infected with hepatitis B virus in China, of which has 120 million long-term carriers, labeled China as a “Hepatitis B Country”.
▲Zhao Kai, Former Director ofBIBP
To wipe out such label, China has listed the study on plasma-derived Hepatitis B (HepB) vaccine as a key project of national sci-tech research since the “The 6th Five-Year Plan” period, with Zhao Kai, Academician of the CAE at the BIBP, as the project leader.
The plasma-derived HepB vaccine was successfully developed through the joint efforts of the project staff led by Mr. Zhao Kai. At that time, about 20 million doses of plasma-derived HepB vaccine were produced annually in China, with immunogenicity in children reaching over 95%, and the blockage rate of mother-to-child transmission reaching over 85%, indicating that the quality of the vaccine was comparable to its international counterparts.
Although the plasma-derived HepB vaccine was safe and effective, it was inherently defective and could only be used as a transitional vaccine since it uses the blood of hepatitis B surface antigen (HBsAg) carriers as its raw material.
In 1986, Mr. Zhao Kai suggested introducing the advanced modular industrial production technology of recombinant hepatitis B vaccine from abroad. In 1989, approved by the State Development Planning Commission and the Ministry of Health and led by Mr. Zhao Kai, BIBP took the lead in introducing the world’s first genetically engineered product — Merck’s industrial production technology of recombinant hepatitis B vaccine.
Subsequently, BIBP organized certain personnel to assimilate the key imported technology, and successfully prepared the vaccine that met the requirements. Clinical observation proved that the recombinant hepatitis B vaccine has outperformed the other hepatitis B vaccines in blocking mother-to-child transmission of hepatitis B, with a blockage rate of up to 90%.
In the research and development (R&D) process of recombinant hepatitis B vaccine, Mr. Zhao Kai managed to improve the purity of hepatitis B vaccine to 99.9% by using advanced gene recombination technology. The quantity and the quality of hepatitis B vaccine had been continuously improved. For more than half a century, Mr. Zhao Kai had been dedicated to the R&D of viral vaccines. There are several new vaccines developed under his leadership, which had been popularized and applied, and had contributed greatly to the prevention and control of related viral infectious diseases.
Both the plasma-derived vaccine and genetically engineered recombinant hepatitis B vaccine researched and developed by BIBP have won the 1st prize of National Science and Technology Progress Award. It is one of a kind in the history of science and technology awards that a vaccine has won two national 1st prizes in a row.
As the first national institute to conduct the prevention of epidemic and the research and production of serum-derived vaccines, BIBP has developed and produced 15 kinds of vaccines in China against vaccinia, cholera, typhoid, rabies, diphtheria, hepatitis B, etc.
During the outbreak of COVID-19 epidemic at the beginning of 2020, BIBP, as a member of the national team of central state-owned enterprises, has set up a scientific research team immediately. The team went through days and nights to develop the Inactivated COVID-19 Vaccine (Vero Cell), which was approved by the National Medical Products Administration (NMPA) for conditional marketing on December 31, 2020. This result is satisfactory and promising to the nation and the people. Meanwhile, BIBP continued to enhance the R&D and production of Inactivated Omicron COVID-19 Vaccine (Vero Cell), which was approved for clinical use by Hong Kong, NMPA and the UAE successively on April 13, April 26, and April 29, 2022, respectively. These achievements have defined BIBP on its leading role of the development of vaccines for COVID-19 variants, contribute our Chinese strength to the global fight against COVID-19, and provide more and better vaccine products for all mankind.
BIBP never stops, we move forward in a determined quest, and strive in the pain of change. BIBP continues to enlarge investment input, improve conditions, and cultivate talents for scientific research. By June 2022, BIBP has had 317 postgraduates and 31 PhDs, which lays a solid foundation for its scientific research strength, helps BIBP develop into a world-class enterprise and promotes higher quality development.
The construction of BIBP’s R&D Incubation Center was commenced in June 2021. With the joint efforts of top domestic experts from Tsinghua University, Nankai University and other institutions, BIBP has constructed a cutting-edge, large-scale and intensive R&D building, also a joint R&D center, that can provide concrete support for promoting the sci-tech innovation of BIBP, building an open innovation framework, meeting the major national strategic needs, and offer broader space for the majority of biomedical talents.
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