Sinovac's EV71 Vaccine Phase I Clinical Data for the Prevention of Epidemic Hand, Foot, Mouth Disease Published in Vaccine

Sinovac Biotech Ltd. SVA, a leading provider of biopharmaceutical products in China, announced today that the positive Phase I clinical data for its proprietary inactivated Enterovirus 71 (EV71) vaccine against hand, foot and mouth disease (HFMD) was accepted for publication by the peer-reviewed journal Vaccine on March 4, 2012, and the uncorrected proof is available online as of March 14, 2012. The article, entitled "Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial," provides an in-depth look at the safety observation with preliminary immunogenicity data from the study, in which all three age groups (adult, children and infant) showed good safety and tolerance profiles. In the Phase I clinical trial, the vaccine candidates were given to the adults first, starting from the lowest dosage to higher dosages. After the two inoculations were administered to the adults, a safety observation was conducted, and the safety evaluation report was reviewed by clinical experts as well as the Data Safety and Monitoring Committee (DSMC). Once safety was confirmed, inoculations were administered to the children, and the same procedure was followed before the infants were inoculated. This trial protocol was approved by the Ethics Committee. The Phase I clinical trial showed that Sinovac's novel inactivated human EV71 vaccine was well tolerated in healthy volunteers, and the testing results on neutralizing antibody indicated good immunogenicity. Sinovac confirmed these data in the Phase II trial, which demonstrated that the EV71 vaccine demonstrated a good immunogenicity and a favorable safety profile with no vaccine-related serious adverse events.