The China State Food and Drug Administration (SFDA) has approved Sinovac Biotech to start clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).
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As per the approval, Sinovac is required to conduct each phase of the human clinical trials in accordance with SFDA requirements, to conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and to conduct efficacy study in the Phase III clinical trial.
Sinovac chairman, president and CEO Weidong Yin said that their R&D people has successfully completed pre-clinical research and made significant breakthroughs during the development.
"We will move forward with our research and development of vaccines with the objective to supply high quality vaccine products to children worldwide as soon as possible and to contribute to the prevention and control of HFMD," Yin said.
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