GAO urges HHS to speed antiviral, prepandemic vaccine plans

Lisa Schnirring

Oct 6, 2008 (CIDRAP News) In a recent progress report to Congress on federal influenza pandemic response planning, the Government Accountability Office (GAO) recognized a host of obstacles but cited two areas that officials could make headway on: finalizing guidance on allocating antivirals and developing guidance on how to prioritize groups to receive prepandemic vaccine in the early stages of a pandemic.

The 72-page report, focusing on the US Department of Health and Human Services' (HHS') pandemic response plans, was published on the GAO's Web site on Sep 30.

Investigators looked at three response components that the GAO and outside experts have said need improvementspharmaceutical intervention, healthcare surge capacity, and public communications. Though the GAO gave detailed status reports for all three of the areas, it made recommendations only about pharmaceutical interventions.

"We believe that finalizing guidance on the use of pharmaceutical interventions will be crucial for responding to a pandemic outbreak and that the necessary guidance documents should be finalized as soon as possible," the GAO wrote.

In June HHS released draft guidance on the use of antivirals during an influenza pandemic. The agency's goal is to place 75 million treatment courses in the Strategic National Stockpile, and draft guidance proposes that the private sector stockpile 110 million additional treatment courses.

The proposed guidance, developed by an interagency task force, advised that antivirals in government stockpiles be used to treat people who are ill, especially when supplies are scarce, and that antivirals for preventive use be mainly drawn from private stockpiles. The draft document did not attempt to prioritize groups.

In a letter responding to the GAO report, Vincent Ventimiglia, Jr, assistant secretary for legislation at HHS, wrote that the agency is in the process of updating the proposed guidance on antiviral use during a pandemic, on the basis of feedback it received during the public comment period. The comment period was set to end on Jul 3, according to a May 23 Federal Register notice.

In its other recommendation, the GAO advised HHS to release guidance for using and prioritizing prepandemic vaccine designed to protect against a pandemic virus before a vaccine closely matched to the actual pandemic strain is available. Federal officials are already stockpiling a prepandemic vaccine based on the H5N1 virus.

In June HHS released its official guidance on allocating pandemic vaccine, which would be developed after the start of a pandemic and designed to match the circulating strain. HHS officials project that it would take 20 to 23 weeks after the start of a pandemic to start producing the first doses.

As for prepandemic vaccine stockpiles, the GAO report says HHS will oversee the distribution and administration to workers who are needed to keep society functioning until a pandemic vaccine becomes widely available. According to the report, the National Infrastructure Advisory Council has estimated that the critical workforce numbers about 20 million people, and HHS' goal is to stockpile enough to cover that number.

However, HHS has not yet released draft guidance on prioritizing target groups for prepandemic vaccines. HHS officials told GAO investigators that target groups for the prepandemic vaccine would likely resemble those for the pandemic vaccine, but would have more of a critical workforce focus. They also said that a tiered approach like that used for the pandemic vaccine would be needed only if a pandemic occurs before HHS reaches its goal of stockpiling enough for 20 million people.

The GAO said establishing target groups in advance is a key component of pandemic planning and warned that HHS could encounter problems if it doesn't issue graft guidance for prepandemic vaccines in a more timely manner. "This lack of essential information could slow the initial response at the state and local levels and complicate the general public's understanding of the necessity for rationing these interventions," the GAO wrote.

Investigators also said a public comment period after the draft prepandemic vaccine allocation plan is announced is a useful step. "Public participation is an essential component for acceptance of tough decisions that will be required unless and until greater capacity or a universal vaccine can be developed," the report said.

In his response accompanying the GAO report, Ventimiglia wrote that HHS will release its proposed prepandemic vaccine allocation guidance "in the near future."

Bill Hall, an HHS spokesman in Washington, DC, told CIDRAP News that the agency has been working on the draft allocation plan, but that it isn't finished and the agency can't yet say when it will be.