HHS has enough H5N1 vaccine for 4 million people

Jul 5, 2006 (CIDRAP News) – In an update on pandemic influenza preparedness efforts, the federal government said last week it had stockpiled enough vaccine against H5N1 avian influenza virus to inoculate about 4 million people and enough antiviral medication to treat about 6.3 million.

Health and Human Services (HHS) Secretary Mike Leavitt said his department has stockpiled about 8 million doses of H5N1 vaccine. "Given a two-dose vaccination schedule, this would allow vaccination of 4 million people," Leavitt wrote in a 12-page report.

The report outlines the status of federal efforts to boost US flu vaccine production capacity, increase the stockpile of antiviral drugs, monitor the spread of avian flu in the United States, and assist states with pandemic planning. The report is a follow up to a March report that announced the government's initial plan for boosting the nation's supply of avian influenza vaccines and treatments.

The H5N1 vaccine being stockpiled now is based on a virus isolated from a Vietnamese patient in 2004 (a clade 1 virus), Leavitt noted. He said a second H5N1 vaccine under development is based on an H5N1 strain that was collected in Indonesia in 2005 (clade 2 virus) and has circulated in Europe, Africa, and parts of Asia.

"While the efficacy of these pre-pandemic vaccines cannot be predicted, there is reason to believe they may provide some level of protection for priority personnel and those at greatest risk," Leavitt wrote.

Boosting antiviral stockpiles
Leavitt reported that as of Jun 1, the Strategic National Stockpile (SNS) of antiviral drugs contained about:

  • 6.2 million treatment courses of oseltamivir (Tamiflu) capsules, with an additional 15.4 million courses expected by the end of December
  • 8,600 courses of Tamiflu oral suspension
  • 84,000 courses of zanamivir (Relenza), with an additional 3.9 million courses expected by the end of December

In sum, the stockpile is expected to reach 26 million antiviral drug courses by the end of 2006. At least 20 million courses are earmarked for states for distribution in proportion to population, the report says. Up to 6 million courses are reserved for mass prophylaxis in isolated community outbreaks.

HHS received a $170 million appropriation to provide a subsidy to states and other jurisdictions that will allow them to buy up to 31 million treatment courses of antiviral medications at 25% off the federal contract price.

HHS also will spend $162 million to stockpile other medical supplies, including 6,000 ventilators, 100 million N95 respirators, and 50 million surgical masks, plus face shields, gowns, and gloves, Leavitt reported. So far the department has amassed 20.2 million respirators and 12.3 million surgical masks.

Investing in vaccines
In May, federal officials awarded more than $1 billion worth of contracts for cell-based vaccine technology. Leavitt wrote that reliance on traditional egg-based vaccine production is problematic because an avian flu outbreak, and the poultry culling that would follow, would jeopardize the supply of eggs needed to produce the vaccine. He said vaccine-production cell lines can be frozen indefinitely and that, in comparison with eggs, can more rapidly be used to produce vaccines in the event of a pandemic.

Contracts for cell-based vaccine production went to five companies: Solvay Pharmaceuticals ($299 million), GlaxoSmithKline ($275 million), Novartis Vaccines & Diagnostics ($221 million), MedImmune ($170 million), and DynPort Vaccine ($41 million).

Another HHS goal is to expand the nation's capacity for producing the traditional egg-based vaccine. Leavitt wrote that this summer the HHS will issue requests for proposals (RFPs) for building new facilities or retrofitting existing ones.

HHS also has issued RFPs for antigen-sparing vaccine technologies that would stimulate protection using a smaller amount of the vaccine, the report says.

Coordinating state preparedness
Congress allocated $350 million this year to assist with state and local pandemic preparedness. Of this amount, Leavitt said $100 million has already been earmarked to help states identify gaps in preparedness. They are now submitting applications for how they will spend $250 million, which is intended to cover the cost of ranking gaps and making plans for addressing them, developing plans for distributing antiviral drugs, and designing pandemic response exercises.

Leavitt said HHS has convened state summits in 48 states, and the remaining two have summits scheduled. He added that many states have progressed to the next step of holding interstate and regional planning meetings.

This fall HHS will begin holding risk-communication training sessions for state and local public health professionals and community leaders in 10 HHS regions. "State by state, we are moving from awareness to preparedness," Leavitt wrote.

Other developments
Leavitt's report describes several other elements of federal pandemic planning activities, including:

  • International cooperation: The nation has pledged $334 million to assist nations most severely affected by avian influenza. In May, HHS shipped Tamiflu to a secure location in Asia to help contain a pandemic. (If containment is not possible, the drug would be sent back to the US.)
  • Domestic monitoring: The government has expanded its early detection network to monitor wild birds. Sampling in Alaska is focused on species that are thought to have the highest chance of bringing the virus to North America: those that migrate to and from wintering areas in the Russian Far East and Southeast Asia.
  • Diagnostic tests: In collaboration with the Centers for Disease Control and Prevention (CDC), the Food and Drug administration recently approved a new laboratory test that can detect H5 flu viruses within a few hours. In April, the FDA provided the biotechnology industry with guidance for evaluating performance and writing product labeling for in-vitro diagnostic tests.
  • Flu-tracking software: The CDC developed two pandemic modeling software programs—FluSurge and FluAid--for communities and hospitals.
  • Public communication: Leavitt reported that content on the cross-government Web site, pandemicflu.gov, has increased 25% in the last 3 months and that over the last several months HHS has held roundtable talks on avian and pandemic flu with major broadcast and cable networks.

"While we have accomplished much in a short period of time, the race we are in is not a sprint, but a marathon," Leavitt wrote.

See also:

Leavitt's report "Pandemic Planning Update II"

Mar 15, 2006 CIDRAP News article "Leavitt vows action on flu vaccine technology"

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