The HHS awarded two contracts totaling $215 million for advanced development of next-generation recombinant influenza vaccines. Novavax will receive $97 million over the first three years, which can be extended for an additional two years, for a total contract value of $179.1 million. HHS awarded a separate contract to VaxInnate for $117.9 million over the first three years, which can be extended for two additional years, for a total contract value of $196.6 million.
“The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly,” notes HHS Secretary Kathleen Sebelius. “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months, which can save more lives during a pandemic as well as during seasonal flu outbreaks.”
Under its contract Novavax is to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans. VaxInnate is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu. These next-generation recombinant influenza vaccines were supported in early stages by the NIH and are expected to complement currently available and other new influenza vaccines.
Today’s contracts for advanced development are supported by the HHS Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response. The contracts are part of a national pandemic vaccine preparedness strategy, which includes the advanced development of new types of influenza vaccines as well as expanding and diversifying domestic influenza vaccine production and establishing and testing stockpiles of pre-pandemic vaccine. In addition, the recombinant flu vaccine may enhance pandemic vaccine manufacturing surge capacity in the United States.
During the contract’s base period, Novavax expects to conduct three clinical trials with its pandemic influenza VLP vaccine candidate with adjuvants, conduct Phase II and Phase III trials utilizing its seasonal influenza VLP vaccine candidate, and develop a manufacturing facility plan that has the capability to produce finished vaccine within 12 weeks and at least 50 million doses within six months of an influenza pandemic declaration. Additional funded base period activities include vaccine product characterization, process development, and scale-up of recombinant vaccine manufacturing including consistency lot manufacturing and lot-release assay development in support of the Phase III trial.
Novavax’ VLP technology reportedly enables more rapid vaccine production than traditional egg-based methods. The firm separately reported licensing this platform to LG Life Sciences for use in the development of flu vaccines in South Korea and certain other emerging markets. VaxInnate will use BARDA’s funding to evaluate, in clinical trials, the components and combinations of what will ultimately be several different pandemic flu vaccines and a seasonal quadravalent flu vaccine produced using its technology. The firm’s platform involves genetically fusing vaccine antigens to the bacterial protein flagellin, a potent stimulator of the innate immune system.
VaxInnate has already completed a series of Phase I/II trials using VAX125 and VAX128 prototype vaccines for both seasonal and pandemic type A1 flu vaccines. The most recent trial assessed the safety and immunogenicity of three different forms of the VAX128 vaccine in several hundred healthy adults aged 18–49 and more than 100 community-living adults ≥65 years of age in the U.S. VAX128 was demonstrated to be highly immunogenic at low doses (1–2.5 µg) and well tolerated up to 20 µg doses, the firm reports. Further, the trial confirmed the safety and efficacy of the vaccine forms in elderly subjects, who are less responsive to flu vaccines due to the effects of aging on the immune system.