13v combined pneumococcal polysaccharide vaccine of AIM Vaccine has obtained phase-3 clinical ethical approval

2021-10-15 Source:AIM Vaccine

13v combined pneumococcal polysaccharide vaccine (PCV13) recognized as “King of Vaccines” worldwide accepted an important member in domestic front line prior to outbreak of COVID-19 epidemics. PCV13 as independently developed by AIM Vaccine Co., Ltd obtained phase-3 clinical ethical approval from Clinical Test Ethics Committee of Yunnan Provincial Center for Disease Control and Prevention on October 14. This indicates that such vaccine has entered the stage of phase-3 clinical test. Such important innovative product will alleviate short supply of PCV13 in China. As a result of it, more children from 5-6 years old will be under the protection of the homemade innovative vaccine.

Pneumococcal disease is one of the serious public health problems worldwide. Pneumococcal vaccine is generally deemed to be the most effective approach for prevention of such disease. For years, such vaccine technology has been monopolized by Western countries, resulting in short supply in domestic market. For this reason, AIM Vaccine has input enormous R&D forces to accelerate R&D progress. So far, AIM Weixin, one of subsidiaries of AIM Vaccine has completed reconstruction and upgrading of vaccine production line with designed annual output up to 47 million dosages. Wherein, PCV13 in domestic front-line market can effectively satisfy urgent demands in the market.

AIM Vaccine has successfully guaranteed R&D of PCV13 in high efficiency and quality as well as control level of R&D, production and quality based on its advantages over comprehensive technical platform, high capability in promotion of seamless project collaboration and high strength in industrialization. Furthermore, core technologies on PCV13 have carried forward previous similar technical advantages of AIM Vaccine. As indicated by data obtained from tests to animals, ongoing products of AIM Vaccine has manifested a higher immunogenicity than imported vaccines in terms of antibody level of 10 among 13 serums.

Pneumococcus, known as the "health killer" among infants, is the main cause for pneumonia and upper respiratory tract infection, which may result in numerous invasive diseases. Severe pneumococcal diseases may also result in serious sequelae, such as deafness, paralysis and mental retardation. World Health Organization (WHO) has listed inoculation of vaccine for prevention of pneumococcal disease as a prior task. AIM Vaccine expresses that it will accelerate approval of PCV13 for launch to provide high-quality homemade pneumococcal vaccine for assurance of healthy growth of infants.

(Pictures in the text show pneumococcal vaccine workshop of AIM Weixin as reconstructed and upgraded)