EVALUATION OF THE QUALITY OF THE EV71 VACCINE MANUFACTURED BY MEDIGEN, BASED ON SAFETY, ENDOTOXIN, POTENCY, AND IDENTITY TESTS

Abstract

The EV71 vaccine (for Hand, Foot and Mouth Disease – HFMD) is currently undergoing the regulatory submission process for registration in Vietnam. Only vaccine lots that meet all established stringent quality standards are granted a Certificate of Quality by the National Institute for Control of Vaccines and Biologicals (NICVB). A comprehensive quality assessment necessitates the execution of physicochemical, biochemical, and other specialized tests across various specialized departments. For this specific vaccine lot, the Department of Viral Vaccine Control was responsible for conducting the general safety test, endotoxin test, potency test, and identity test. The recorded results demonstrated that the vaccine successfully met all criteria: in the general safety test, all challenged mice remained healthy and demonstrated weight gain; the endotoxin level was determined to be less than 0.3 EU per dose; the identity test yielded a positive result for the presence of the EV71 virus; and finally, the potency test indicated that 85.7% of immunized mice developed an immune response with an Antibody Neutralization Ratio ≥117.