HHS Awards $132.5 Million toward H5N1 Vaccine Development

Washington, DC (Jan. 17)-The US Department of Health and Human Services (HHS, Washington, DC, www.hhs.gov) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million doses of the vaccine or enough adjuvant for 150 million doses within six months of the onset of an influenza pandemic.

An adjuvant reduces the amount of antigen needed per dose. Although the typical trivalent influenza vaccine uses 15 µg of antigen per dose, studies have shown that H5N1 vaccines may require as much as 90 µg of antigen per dose, with two doses necessary to achieve the desired immunogenicity in people.

GlaxoSmithKline (Philadelphia, Pennsylvania, www.gsk.com) and Novartis Vaccines and Diagnostics (Emeryville, CA, www.novartis.com) each were granted five-year contracts totaling $63.3 million and $54.8 million, respectively. Iomai Corporation (Gaithersburg, MD, www.iomai.com) will receive a 15-month grant of $14.4 million to complete Phase I clinical trials of its vaccine. Upon successful completion of these trials, the company will receive an additional $114 million.

According to the company, GSK will engage in research and development work leading to the licensure of antigen-sparing prepandemic and pandemic vaccines with adjuvant. GSK already began shipping as many as 15.5 million treatment courses of its antiviral “Relenza” (zanamivir for inhalation) as part of its agreement with the US government to build up the country’s flu pandemic stockpiles. 

The current award is the fourth that Novartis has received from HHS to support the government’s pandemic preparedness efforts. Novartis plans to further develop its MF59 adjuvant in a cell-culture-based pandemic influenza vaccine and support the design, equipment, and validation for an MF59 production facility in Holly Springs, NC.

Iomai is developing a skin patch that, when used with an injectable influenza vaccine, is designed to stimulate an immune response to even small doses of the vaccine, thereby potentially extending the vaccine supply during a pandemic. The dose-sparing patch includes a potent adjuvant and is affixed on the injection site. The adjuvant is then released through the skin and targets Langerhans cells. These skin cells carry the adjuvant to the lymph nodes, where it boosts the immune response to the vaccine (transcutaneous immunication).

Avian influenza has been linked to more than 260 cases in humans in more than 10 countries and has spread to millions of birds in more than 40 countries.