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October 2007 NVAC Meeting Minutes - page 21 / 40





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October 2007 NVAC Meeting Minutes

Dr. Strikas asked how often the vaccine stockpile is used for outbreak control. He also asked if there are other countries that have vaccine stockpiles from which the United States could learn. Dr. Wallace commented that the stockpile was most recently used during the mumps outbreak in the Midwest. He explained that some 317 vaccine was used, some State-funded vaccine was used, and that Merck donated some vaccine during the outbreak. The vaccine stockpile was also recently used in the Marshall Islands. Dr. Wallace was not familiar with any other countries with vaccine stockpiles.

Mr. Alan Tom commented that in Canada, there is no federal funding for vaccine procurement; therefore, there is no national stockpile. However, Canada has started building stockpile requirements into the contracting process. As the contract comes to a conclusion, the stockpile is drawn down and used within the contracting period.

Dr. Humiston asked if the costs for storage and handling of vaccines in the stockpile are part of the contract or if they could be separated out. Dr. Wallace explained that these are part of a separate contract that gets negotiated periodically.

Dr. Hosbach explained that the vaccine stockpile serves as an insurance policy for the Nation. However, he also stated that in the case of nonemergency drawdowns, risk is not shared. Dr. Wallace mentioned that the issue as to whether the vaccine stockpile is an insurance policy or not is something the working group needs to take on.

Dr. Wallace responded to a question about possession of vaccines in the stockpile by explaining that it is managed at the manufacturers so that they can store and rotate it. He went on to explain that it is a segregated inventory as CDC does go periodically to the manufacturer to count doses to verify the stock.

Dr. Birkhead wondered what would happen when 317 vaccine is expired or gone from the stockpile. Dr. Wallace explained that 317 vaccine does continue to get rotated in.

As more complicated issues arise, Dr. Wallace said he would present them to the Committee for their input. Dr. Birkhead was hesitant to appoint a liaison member at this point; however, Dr. Wallace mentioned the possibility of making NVPO a working member of the group.

Draft Guidance on Prioritization of Pandemic Influenza Vaccine—Dr. Benjamin Schwartz

Dr. Benjamin Schwartz began his presentation by focusing on why pandemic vaccine needs to be prioritized. He explained that it currently takes a minimum of 20 weeks before the first pandemic vaccine will be available. The United States currently does not have the production capacity to rapidly produce the vaccine for the entire population. Therefore, targeting groups for either earlier or later vaccination will best support the pandemic response goals of reducing health, societal, and economic impacts.

In order to improve our ability to rapidly vaccinate the entire U.S. population, HHS has invested over $1 billion to

Increase vaccine production capacity;

Develop and license new vaccine production technologies; and

Evaluate adjuvanted vaccine formulations.

Dr. Schwartz reminded the Committee that it is unclear whether or how much pandemic vaccine would be available at the time of the first pandemic wave. A mathematical model predicted that if an outbreak were to occur in Southeast Asia, it would take 55 days for the first case to appear in the United States and

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