GAO cites barriers to antiviral, vaccine roles in pandemic

(NIH) for its support of influenza research and surveillance and highlights the Centers for Disease Control and Prevention’s (CDC’s) role in characterizing and tracking the global spread of the H5N1 virus. Nonexistent or poor distribution networks in many countries will hamper the release of antiviral or vaccine stockpiles, the GAO warns, citing one of its earlier investigations that found 10 of 17 countries reviewed didn’t have plans for mobilizing medical countermeasure stockpiles. A lack of distribution networks is particularly an obstacle to antiviral utilization, because experts recommend that the drugs be taken within 48 hours of symptom onset, the GAO says.

Best to utilize antivirals and vaccines, health officials need a reliable, fast diagnostic test to identify patients who have H5N1 infections, the report states. Though the CDC awarded four companies $11.4 million to develop new diagnostic tests, the agency estimates that approval and commercialization of the devices will take two or three years. More international support for clinical trials is needed to spur the development and evaluation of antivirals and vaccines, the GAO says. The report notes that most of the support for these studies comes from only four countries: the United States, Australia, Japan, and the United Kingdom. Health officials have hoped that establishing greater global demand for seasonal influenza vaccines could help build greater vaccine production capacity, but the GAO says some countries are too overwhelmed to participate. “Seasonal influenza programs compete with many other public health priorities for limited budgets in developing countries,” the report states. “Citing Vietnam as an example, NIH officials told us that countries may have been too overwhelmed with H5N1 outbreaks to accept offers of assistance to develop vaccine production infrastructure.”

The WHO, HHS, and the U.S. State Department were asked to review the GAO report in draft form. The GAO said the WHO commented in an e-mail that the report was “comprehensive and useful.” HHS, in a letter accompanying the GAO report, emphasized that vaccines and antivirals are only one part of the government’s pandemic response plan. The State Department and HHS both questioned the GAO’s use of the term “forestall” when referring to using antivirals and vaccines during a pandemic. “While preventing a pandemic from occurring is the goal that all strive for, whether it can actually be achieved is not known,” wrote Vincent Ventimiglia, assistant secretary for legislation at HHS, in a letter accompanying the report. The GAO said, however, that its use of the word “forestall” is consistent with the WHO’s usage of the term.