Getting six cell-based influenza vaccine manufacturing plants up and running in the United States should be the first of four priorities for the next Secretary of Health and Human Services, advised Secretary Mike Leavitt.
“The highest priority of the next administration should be to expand U.S. production of cell-based technology, so that in a 6-month period, we could generate enough pandemic flu vaccine in this country to protect every American,” Secretary Leavitt said during a Webcast. “We have invested more than $1 billion in this, and now have six companies in various stages of implementing either cell-based manufacturing or expanded egg-based vaccine production. The goal is to complete these contracts by 2011.”
The importance of cell-based vaccine manufacturing can't be overstressed, he said. GlaxoSmithKline, MedImmune Inc., Novartis, DynPort Vaccine Co., Solvay Pharmaceuticals Inc., and Sanofi Pasteur have all received federal grant money to develop vaccines. “There are not enough chickens in the world to get this done in the case of a pandemic. These contracts have to be fulfilled and the factories built.”
Second, the free international sharing of viral samples for vaccine research needs to be addressed, he said. “We need to strongly defend the sample-sharing network against short-term opportunism. For years, nations have freely shared viral samples, and this is now being threatened by nations who want to hold their samples for compensation—they feel the virus is their intellectual property and insist on royalties if anyone makes a vaccine out of it.”
A January 2007 decision by Indonesian authorities to withhold all clinical specimens from suspected cases of human bird flu A (H5N1) fueled this concern. According to the World Health Organization, which manages international sample sharing, the country rescinded this ban in March 2007. But the idea that countries could turn a profit from research samples seems to have taken root in some of the international community, according to a recent report of the European Centre for Disease Prevention and Control.
The May 2008 report noted that “to date, no other countries have publicly made moves like those of Indonesia, although some others have been considering their positions. Other countries not traditionally concerned have been supporting the Indonesian position; the debate has become politicized internationally and attitudes have hardened.” (See http://ecdc.europa.eu/pdf/ECDC_influenza_briefing.pdf
The international community must take a strong stand against these tactics, Secretary Leavitt said. “Meeting their demands would result in the downfall of our very important sharing strategy. The system would fail and subject the entire world to more danger.”
Third, the new administration will also need to concentrate on countermeasure distribution. “We have an important stockpiling system [of medications and equipment] and we can get massive amounts of supplies anywhere in the U.S. within 2 hours. But getting the pills into the people is our Achilles' heel and it needs work. Not every state is prepared to handle this, and this failure is potentially catastrophic.”
Ultimately, distribution will be a state and local issue. “Public health is a local responsibility because localities are better at accomplishing this mission than the federal government is. Before leaving this administration, I want to release a state-by-state evaluation so people can know if their officials are meeting the standards we need to achieve.”
Tough economic times, Medicaid growth, and a new culture of disaster dependence might interfere with local commitments to pandemic planning, however. “We have to resist the tendency for local and state governments to use budget limitations to upwardly allocate disaster preparedness. Public health is one of a number of important functions being crowded off the budget table by the unconstrained growth of Medicaid eating up state budgets.”
Also, he said, “A cultural change that began with Hurricane Katrina has begun to drive a federalization of public health. But I want to tell you, the state or community that fails to prepare, with the expectation that the federal government will come to the rescue at the last moment, will be tragically disappointed.”
Finally, HHS must keep pandemic preparedness on national and local agendas. “The media buzz about bird flu has died down, but the virus has not,” he said. Publicity is a tightrope act, in that “when we discuss it in advance, we come off as alarmist, but if we don't discuss it until it starts, then none of our preparations will be adequate. We need to speak of this in a way that stimulates discussion, not panic.”