Hardcore Technology ▏AIM Convac Submitted Clinical Application for EV71-CA16 HFMD Vaccine (HDC) to CDE

2021-12-09 Source:AIM Bio
A few days ago, AIM Convac, a subsidiary of AIM Vaccine Co., Ltd, submitted its application of communication session for the EV71-CA16 bivalent HFMD vaccine (human diploid cell) it developed to the Center for Drug Evaluation (CDE), NMPA, thus entering the communication stage. This candidate vaccine can target the two most common pathogens causing the hand-foot-and-mouth disease, i.e., enteric virus type 71 (EV71) and Coxsackie virus group A type 16 (CA16), to play an immunoprotective role in the comprehensive control and prevention of an HFMD epidemic.

Hand-foot-mouth disease (HFMD) is a viral infection affecting infants and children with its annual incidence rate continuously rising in the past two decades. Since 2008, the results of epidemiological surveys targeting the majority of regions in China have shown that the percentage of HFMD caused by EV71 and CA16 both ranges from 60% to above 70%.

According to epidemiological statistics, with the extensive use of EV71 virus in the Chinese market, the percentage of EV71-induced HFMD has declined significantly. In contrast, the percentage of CA16-induced HFMD seems more prominent. Therefore, to control the overall incidence rate of HFMD with multivalent vaccine has become a major issue that has aroused great concern from the industry and all sectors of the society.

After years of devotion to R&D, AIM Convac has solved multiple key technical problems in the development of bivalent HFMD vaccine one by one. The results of preclinical studies indicate: by targeting EV71 and CA16 infection, this bivalent vaccine can induce the body to reach an effective neutralizing antibody level, cause the immune system to initiate good cell-mediated immune responses, and equip immune animals with protective immunity against virus attack. With human diploid cells as the substrate, this viral vaccine can lower the possible risks of adverse reaction brought by materials with exogenous substrate to a greater extent.

Since 2000, the incidence of child’s HFMD has been concentrated in Asia and the Pacific region, with its average annual incidence ranging from millions to tens of millions. According to the statistics in the report on notifiable communicative diseases by the Chinese Center for Disease Control and Prevention, from January to October 2021, the incidence of HFMD in China accounts for 42.19% of Class C communicative diseases nationwide. Since this communicative disease mainly affects children under the age of 2, with a certain percentage of severe cases and deaths, child’s HFMD has become a major public health issue. 

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