On January 10, 2024, it was jointly developed by Sinovac Holding Biotechnology Co., Ltd. (hereinafter referred to as "Sinovac Sinovac") Vaccine Technology Co., LtdOral hexavalent reassortant live attenuated rotavirus vaccine (Vero cells).Obtained the approval notice of drug clinical trial from the National Medical Products Administration (NMPA).
National Medical Products Administration**.
The vaccine coversG1, G2, G3, G4, G9, P1A[8].There are a total of six rotavirus serotypes, which are currently under development in ChinaCovers the widest range of typesOne of the rotavirus vaccines.
Human rotavirus (HRV) is one of the leading causes of severe gastroenteritis and death in children under 5 years of age1 and the most common cause of severe diarrhoeal disease in infants and young children worldwide2. Diarrhoea is the second leading cause of infectious disease deaths in children under 5 years of age worldwide**, and rotavirus gastroenteritis (RVGE) is the cause of severe fatal diarrhoea in children in this age groupFirst and foremost**。Globally every year10 million seriously illRVGE cases and11.80,000 1830,000 deaths, about 41% of these deaths occur in:Asia
Globally, 41 g genotypes and 57 p genotypes of rotavirus have been identified to date3, of which:6 G type(G1, G2, G3, G4, G9 and G12) and3 p-types(p[4], p[6], p[8]) predominated4. Surveillance data in China show that the main RV strains circulating in China after 2012 are G9P [8], G3P [8], G1P [8], G2P [4] and othersg4p[8], there were no differences in dominant genotypes between different regions of China. From 2012 to 2017, G9P [8] replaced G3P [8] as the dominant strain, accounting for a large number of, and by 2018, G9P [8] accounted for5,6。However, rotavirus serotypes are not covered by rotavirus vaccines that are now available.
In order to meet the needs of rotavirus prevention and control, Sinovac has prepared a hexavalent vaccine using human-bovine rematching, covering more than 90% of the rotavirus types circulating in China.
Hu Yaling, general manager of Sinovac R&D, said
It is hoped that this product will be available as soon as possible to better protect children from rotavirus. Sinovac has always focused on scientific innovation in the field of biomedicine, and continues to expand its product pipeline through independent research and development, external cooperation and other ways to meet the needs of disease prevention and treatment. In recent years, a number of Sinovac products have been approved for clinical trials, and some products under development have entered the later stage of research. ”
In the future, Sinovac will continue to promote the research and development of multi-platform and multi-category products, and provide high-quality products and services for global disease prevention and control.
References. 1] Expert consensus on immune prevention of rotavirus gastroenteritis in children (2020 edition) [J].Chinese Journal of Practical Clinical Pediatrics, 2021, (1): 2-13
2] Yangtze River Delta Immunization Program Integration Project Team, and Pediatric Infection and Hepatology Group of the Infectious Diseases Branch of the Chinese Medical Association. "Expert consensus on the prevention and treatment of rotavirus gastroenteritis in children (2020 edition)."Chinese Journal of Preventive Medicine 544(2020):14.
3]manouana, gédéon prince et al. “molecular surveillance and genetic divergence of rot**irus a antigenic epitopes in gabonese children with acute gastroenteritis.” ebiomedicine vol. 73 (2021): 103648. doi:10.1016/j.ebiom.2021.103648
4]santos, norma, and yasutaka hoshino. “global distribution of rot**irus serotypes/genotypes and its implication for the development and implementation of an effective rot**irus vaccine.” reviews in medical virology vol. 15,1 (2005): 29-56. doi:10.1002/rmv.448
5]zhou, xuan et al. “surveillance of human rot**iruses in wuhan, china (2019-2022): whole-genome analysis of emerging ds-1-like g8p[8] rot**irus.” international journal of molecular sciences vol. 24,15 12189. 29 jul. 2023, doi:10.3390/ijms241512189
6]peng, rui et al. “reassortment and genomic analysis of a g9p[8]-e2 rot**irus isolated in china.” virology journal vol. 20,1 135. 22 jun. 2023, doi:10.1186/s12985-023-02064-5