Sinovac Biotech yesterday announced that the positive phase I clinical data for its proprietary inactivated Enterovirus 71 (EV71) vaccine was accepted for publication by Vaccine, a peer-reviewed journal. The uncorrected proof is available online.
The EV71 vaccine is an inoculation against hand, foot, and mouth disease (HFMD). The article, entitled “Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial,” gives a detailed look at the safety observation with preliminary immunogenicity data from the study, in which all three age groups (adult, children, and infants) showed good safety and tolerance profiles.
During the phase I clinical trial, vaccine candidates were first given to the adults, starting from the lowest dosage to higher dosages. After the two inoculations were administered, a safety observation was conducted and clinical experts and the Data Safety Monitoring Committee reviewed the safety evaluation report. When safety was confirmed, inoculations were then administered to the children; the same procedure was followed before the infants were inoculated. The Ethics Committee approved this trial protocol.
The results of the phase I clinical trial showed that Sinovac’s novel inactivated human EV71 vaccine was well tolerated in healthy volunteers, and good immunogenicity was indicated in the testing results on neutralizing antibody. The company confirmed these findings in the phase II clinical trial, which showed that the EV71 vaccine demonstrated a good immunogenicity and a favorable safety profile with no serious vaccine-related adverse events.
In January, Sinovac commenced phase III clinical trials prior to the hand, foot, and mouth disease outbreak season. Around 10,000 healthy volunteers were enrolled through the end of March. The phase III trial is progressing on schedule and is anticipated to be completed in the first half of 2013. The construction of an EV71 vaccine production plant is also underway to be ready for production as soon as the vaccine is approved.
More than 90 percent of reported hand, foot, and mouth disease cases occur in children under the age of 5, and the epidemic situation is still serious in China. HFMD is common in childhood and usually mild, but there has been an increase in severe cases reported that are associated with neurological problems caused by EV71. Sinovac’s progress brings the world one step closer to a novel vaccine that is effective against human EV71 outbreaks.
Sinovac Biotech Ltd. is a biopharmaceutical company based in China. Sinovac’s focus is on researching, developing, manufacturing, and commercializing vaccines that protect against human infectious diseases, as well as animal rabies vaccines for canines. In 2009, Sinovac was the first company in the world to get approval for its H1N1 influenza vaccine, Panflu. 1. Sinovac has a number of new pipeline vaccines currently in development. The company primarily sells its vaccines in China, with some selected vaccines exported to Mongolia, Nepal, and the Philippines.
For more information, visit the company’s Web site at www.sinovac.com
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