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Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials (China)

This article was originally published in PharmAsia News

Executive Summary

Sinovac Biotech has reported no serious adverse events from the Phase I and Phase II clinical trials for its vaccine designed to prevent the deadly H5N1 strain of bird flu. Sinovac had been given official approval to conduct the trials in April by the China State Food and Drug Administration. The first Phase II trial tested the vaccine on 401 patients ranging in age from 18 to 65. All participants were given either a 5 ug, 10 ug, or 15 ug dose of the vaccine. The second Phase I and Phase II trials divided 160 volunteers ranging from age three to 70 into four age groups. The same dosing rules applied to these groups with the addition of a 30 ug dose. Sinovac has also announced it will soon be reporting its official financial results for the third quarter. The Chinese company, which specializes in developing vaccines, already has treatments approved for Hepatitis A and B as well as normal influenza. (Click here for more
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