Sinovac Starts Next Phase In Pandemic Flu Vaccine Trial

Sinovac Biotech (SVA) has started its Phase II trial of Panflu, an avian flu vaccine for the H5N1 strain of the disease. The trial is a randomized double-blind study that will examine the safety and efficacy of the whole viron form of the vaccine, a trial that will involve 400 healthy volunteers. Its results are expected before the end of the year.

The SFDA authorized the trial in April of 2007. In August, Sinovac began the first part of the new authorization by treating subjects in a Phase Ib clinical trial with whole viron H5N1 vaccine and a Phase I clinical trial with split H5N1 vaccine. The whole viron version of the vaccine originally passed a Phase I trial in 2006.

Sinovac is receiving governmental support to underwrite the costs of development and also to build a manufacturing plant that will produce the vaccine. Sinovac has expressed its intention of formulating 20 million doses of the vaccine, even before it is approved, in case avian flu develops into a full-blown pandemic.

In August, Sinovac released financial results for the first half of 2007. The company reported sharply higher revenue and earnings (see story).

SVA 1-yr chart:

Disclosure: none.