Sinovac Biotech Ltd. , Chinese biopharmaceutical company, announced on May 11 that the SFDA recently approved the company to commence the Phase II clinical trial of its Panflu, a human use vaccine against the H5N1 strain of pandemic influenza virus. Panflu was jointly developed by Sinovac with China CDC.

Two types of the H5N1 vaccine were approved by the SFDA to commence clinical trials. The first type is the H5N1 whole viron inactivated vaccine for which the Phase I clinical trial was completed in 2006. The Phase Ib and II clinical trials for the H5N1 whole viron inactivated vaccine will be conducted to further test the tolerance, safety, and immunogenicity and to determine the dosage and inoculation schedule. During the Phase Ib and II trials, the age groups of the participants will be enlarged by adding youths and the elderly. The second type of vaccine is the H5N1 split viron vaccine, for which the Phase I and II clinical trials will be conducted continuously. The trials will focus on the vaccine's tolerance, safety, and immunogenicity.

It is anticipated that the Phase II clinical trials will commence simultaneously for the two types of vaccines in order to determine the vaccination dosage and inoculation schedule for drafting the registration standards and specifications for the vaccine.