GAO says federal investment in flu technology is $2.1 billion since 2005

A recent review by the U.S. Government Accountability Office puts the figure for federal investments in new flu vaccine technology at $2.1 billion since fiscal year 2005.

The U.S. Congress requested the review as part of an effort to increase the speed with which the national flu vaccine supply can be bolstered in a pandemic setting. The government faced serious production delays for the 2009 H1N1 flu vaccine, which was produced using the traditional egg-based method, according to CIDRAP News.

The flu vaccine report was issued along with a GAO review of lessons learned during the federal response to the 2009 H1N1 pandemic.

The 58 page GAO review centered on the roles of the U.S. Department of Health and Human Services and the U.S. Department of Defense in developing and producing new vaccines. Federal HHS investment is considered part of the department’s pandemic preparedness effort and includes research and development, as well as production. The DOD includes vaccine development as part of its military readiness actions, with the department focusing predominantly on production technology.

Approximately $1 billion was spent on HHS investments in new, cell-based vaccine technology, CIDRAP News reports. Two of the six manufacturers that received HHS funding, DynPort and Novartis, have completed clinical trials on cell-based vaccines, and both are expected to apply for U.S. Food and Drug Administration licensure in the next two years.

Both HHS and the DOD have invested in recombinant flu vaccines, which offer the advantage of not relying on unpredictable flu virus replication. The DOD spent $86.9 million in fiscal year 2010 on a project called Blue Angel, which did not result in a completed 2009 H1N1 vaccine, but was able to produce a first batch of antigen in less than 30 days after researchers received information about the virus strain.

Both departments have also awarded contracts for the development of new adjuvanted flu vaccines. GlaxoSmithKline, which received HHS support, anticipates that it will submit its application for FDA licensure of an adjuvanted pandemic flu vaccine in 2011. In total, HHS spent $152 million on contracts for adjuvanted flu vaccines.

The GAO also interviewed pharmaceutical companies and medical associations about obstacles in bringing new vaccine technologies to market, according to CIDRAP News. Low uptake, according to the GAO review, appears to have hampered companies’ plans to develop new seasonal flu vaccines.

Smaller pharmaceutical manufacturers told the GAO that high research and development costs and current economic conditions are further keeping them away from pursuing new flu vaccine technologies. In response, HHS has said it will help by supporting two or three privately owned facilities that can provide expertise to less experienced manufacturers, according to GAO.gov.

Stakeholders also told the GAO that regulatory gaps are apparent in the FDA’s science capacity. Some said that the agency has limited staff expertise with new vaccine technology, making them difficult to work with. HHS hopes to facilitate the review of licensing applications with the FDA in an effort to enhance the agency’s regulatory science expertise.

HHS and the DOD both received drafts of the GAO report on federal investment in flu vaccine technology and concluded that they agreed with the GAO’s findings.