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On November 3, the live attenuated vaccine produced by Sinovac (Dalian) Vaccine Technology Co., Ltd., a subsidiary of Sinovac Holdings Biotechnology Co., Ltd. (hereinafter referred to as Sinovac) has passed the pre-certification of World Health Organization (WHO). According to reports, this is the first chickenpox vaccine product in China that has passed the WHO pre-certified WHO. The vaccine antigen culture uses a new generation of human diploid cell line with Sinovac's independent intellectual property rights.
Researchers are observing the growth status of SV-1 cells
The first domestic chickenpox vaccine passed WHO pre-certification
It is reported that the WHO pre-certification system is an important entry standard for large-scale drug procurement in international institutions and international organizations including UNICEF (UNICEF), and is also a systematic inspection of the R&D, clinical, production, supply and quality systems of enterprises. Up to now, a total of 8 vaccines and products in China have passed pre-certification, and another 3 vaccine products have been included in the WHO emergency use list.
On March 1, 2011, China's national vaccine supervision system passed the WHO evaluation, which means that China's vaccine supervision system has reached the international level, and vaccine products produced by Chinese companies are qualified to apply for WHO pre-certification. In August this year, China's national vaccine supervision system passed the WHO evaluation for the third time, and there were obvious signs of speeding up the pre-certification process of domestic vaccine products.
The Sinovac chickenpox live attenuated vaccine that has passed WHO pre-certified this time is the company's fourth vaccine product that has passed WHO pre-certified. Song Lifei, general manager of Sinovac Vaccine Technology Co., Ltd., said: "Vaccine quality is the lifeline of Sinovac products. The company will take the WHO pre-certification as a new starting point to continuously improve the production quality management level and provide sufficient and high-quality vaccines for the prevention and control of chickenpox diseases in China and the world."
helps the global chickenpox prevention and control
chickenpox is a highly contagious disease caused by the chickenpox zoster virus, which usually leads to symptoms such as itching and blistered rash. It may be accompanied by serious complications such as pneumonia , encephalitis , and infants, pregnant women and people with impaired immune functions are susceptible.
WHO predicts that there are at least 140 million cases of chickenpox-zoster virus infections worldwide each year, including 4.2 million severe infections that require hospitalization. At present, vaccination with chickenpox is the most cost-effective preventive measure. The World Health Organization's Position Document on Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of Vaccines of V The first vaccination time should be at 1 year old, and the vaccination should be again at 4 to 6 years old. After receiving two doses of vaccine, the protective effect of moderate to severe infections is more than 95%.
In June this year, Vaccines published a three-year paper on the research results of Sinovac chickenpox vaccine. The results show that Sinovac live attenuated vaccine can show good immune durability 1 to 3 years after the initial immunization, and children aged 2 to 6 years old show good immunogenicity and safety after the booster dose.
The live attenuated vaccine of Sinovac chickenpox passed WHO pre-certification, which means that Sinovac provides a new "weapon" for global chickenpox disease prevention and control. Up to now, Sinovac has supplied more than 3 billion doses of various vaccine products to the world, covering nearly 80 countries and regions around the world.
Accelerate research and development and innovation
It is reported that Sinovac chickenpox live attenuated vaccine uses the SV-1 human diploid cell line independently developed by Sinovac. This cell line can be widely used in the development of various viral vaccines. The Sinovac chickenpox vaccine passed the WHO pre-certification, marking the once again international recognition of the diploid cell line independently developed by my country.
After undergoing systematic testing of the supply of new coronavirus vaccines at home and abroad, the pace of Chinese vaccine companies in line with international standards is accelerating, but there is still a clear gap compared with global vaccine leading companies. Faced with the international market with intensified competition and more diversified vaccine demand, it is particularly urgent to make breakthroughs in core technologies of Chinese vaccine companies, and increasing efforts to invest in R&D and innovation has become a must for enterprise development.
Kexing has successively built vaccine quality research centers and vaccine high-tech achievements transformation bases, and has established cooperation with many domestic and foreign universities and research institutes to actively promote vaccine research and development and clinical research.
At the same time, many Chinese vaccine companies have successively increased their investment in basic R&D, continued to expand their product lines, and actively promoted the WHO pre-certification of mature vaccine products, and comprehensively helped domestic vaccines continue to benchmark and exceed international standards. I believe that in the future, more domestic vaccines will be seen in the field of global public health governance.
text: Zhang Lei
Edited by: Liu Xinru
Review: Han Lu
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