GAO cites barriers to antiviral, vaccine roles in pandemic

Published 25 January 2008

U.S. Department of Health and Human Services (HHS) says that a pandemic vaccine might play little role in the early phases of a pandemic because it will take 20 to 23 weeks to develop and produce a targeted vaccine

Antiviral medications and vaccines are two tools which many government and health officials hope will stall the spread of an influenza pandemic, but each strategy has daunting challenges, according to a new report from Congress’s Government Accountability Office (GAO). The report, “Influenza Pandemic: Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic,” was requested by four members of Congress who head various health and homeland security committees. It was released this week on the GAO’s Web site. In its report, the GAO acknowledges that national governments and international organizations are working with pharmaceutical manufacturers to expand global production of antivirals and vaccines. It cites, however, a U.S. Department of Health and Human Services (HHS) caveat that a pandemic vaccine might play little role in the early phases of a pandemic, because it will take 20 to 23 weeks to develop and produce a targeted vaccine. Also, the GAO says it would be difficult quickly to expand antiviral production, because of the need to build new facilities, obtain production materials, and gain regulatory approval.

Weaknesses in international surveillance systems are hampering the detection of influenza outbreaks, which the GAO says could limit the ability to promptly administer or develop antivirals or vaccines. “WHO has noted that to increase the likelihood of successfully forestalling the onset of a pandemic, surveillance in affected countries needs to improve, particularly concerning the capacity to detect clusters of cases closely related in time and place,” the report states. “If early signals are not identified, the opportunity for preemptive action will be missed.” Indonesia’s reluctance to share human H5N1 samples with the international community, because of its concerns that the country will not have access to the resulting pandemic vaccines, has further weakened global surveillance efforts in humans, the GAO authors write. Likewise, surveillance of influenza in animals also has shortcomings, the GAO reports. For example, outbreak definitions and reporting methods vary by country, and some countries, such as Djibouti and Uganda, lack the capacity to collect, transport, or identify animal influenza samples.

The GAO notes that the WHO’s revised International Health Regulations, which for most countries took effect in June 2007, are aimed at improving global surveillance. The regulations spell out basic public health capacities countries must have and set a June 2012 deadline for nations to develop them. Also, the GAO lauds the U.S. National Institutes of Health