The HHS awarded DynPort Vaccine (DVC) and Baxter $201.2 million to develop Baxter's cell-cultured seasonal and pandemic influenza vaccines. This modification comes after the firms reported in May 2006 that the contract was potentially worth $242.5 million.
The backing will fund development of the seasonal flu vaccine through FDA licensure and the pandemic vaccine through Phase II trials in adults and pediatric Phase I studies. DVC will provide overall management, while Baxter will manufacture the vaccines and own all clinical data and licenses.
Baxter recently finished a portion of a Phase I/II investigation into the safety and immunogenicity of its cell-culture-derived split-virus seasonal influenza vaccine candidate in Europe. Preliminary data indicates that the vaccine induced antibody responses and good tolerability, according to the company. Also, in the U.S. the first healthy volunteers have been vaccinated with the seasonal flu candidate in a Phase III trial.
Baxter and DVC report that they will enroll patients in a Phase I study for a pandemic influenza clade 2 strain vaccine candidate in 2008 in the U.S.