Groups call for pandemic flu vaccine 'master plan'

Robert Roos

Oct 4, 2006 (CIDRAP News) – Public health and infectious disease experts today called on the United States to develop a "master plan" for development of pandemic influenza vaccines in order to translate scientific advances more rapidly into improved pandemic preparedness.

The recommendation was one of seven pandemic policy suggestions made by the Trust for America's Health (TFAH), a nonprofit public health advocacy group, and the Infectious Diseases Society of America (IDSA).

"The United States must expand and accelerate research efforts and ensure we rapidly translate scientific breakthroughs into real-world practice to prepare for a possible pandemic," Kathleen Maletic Neuzil, MD, coauthor of the report, said in a news release. She is chair of the IDSA's Pandemic Influenza Task Force and an associate professor of medicine at the University of Washington School of Medicine.

The two organizations also called for streamlining the licensing process for pandemic flu vaccines, developing a nationwide system to track the use and effectiveness of seasonal flu vaccine, and relieving states of cost-sharing for the nation's stockpile of antiviral drugs, among other measures.

The recommendations are part of a 26-page report, "Pandemic Influenza: The State of the Science," released by the two groups today. The report discusses the threat posed by H5N1 and other avian influenza viruses and outlines the status of efforts to develop vaccines, drugs, and diagnostic techniques for pandemic flu.

"An effective US vaccine research and development strategic program must be much larger in scale than current funding permits, in addition to being multinational in scope," the report states. It describes current vaccine development efforts as a "patchwork" that may not produce rapid progress.

The groups called for a "Pandemic Vaccine Research and Development Master Plan to systemize and greatly enhance the current U.S. and international vaccine research and development strategies, bringing together the knowledge of government and private industry scientists."

The master plan should include an inventory of all relevant issues and all activities already under way, the report says. The plan should state which sectors are responsible for completing each activity, list funding needs, and provide benchmarks for measuring progress.

The vaccine effort would require a "substantial" increase in funding, the groups say. But in a news teleconference today, TFAH Executive Director Jeffrey Levi declined to name a figure, saying the plan must be developed before its cost can be estimated.

"We recognize that Congress over the last year has invested more than $5 billion toward improving pandemic preparedness," but that is only a starting point for vaccine development and production, Levi said.

In response to questions, Levi said he was uncertain if any legislation would be needed to pave the way for the suggested master plan. In working on HIV and AIDS, he said, "Government found a way to convene the academic community and patients and the private sector to talk about issues and share information without violating intellectual property rights."

Levi and Neuzil were asked if they could say which vaccines now in development are most promising. Neuzil responded that it's difficult to assess the vaccines, because many vaccine trials have been described only in press releases so far, and even scientific journal articles don't always give full technical data.

"From my perspective it's a bit like comparing apples and oranges, because the data I have on each vaccine are in no way equivalent," said Neuzil.

But what is clear, she said, is that "with H5N1 it's likely we'll need more than one dose of vaccine, and we'll need either a high concentration of antigen or we'll need an adjuvant" (a general stimulant of immune response).

The two groups endorse the US government goal of stockpiling enough doses of antiviral drugs to cover about 25% of the population (81 million treatment courses), but they take issue with the funding mechanism. The federal plan calls for buying 50 million treatment courses, but making the states responsible for buying the other 31 million courses, with a 25% federal subsidy.

Levi said the federal government should pay for all 81 million courses. "We need to make sure that every state has the right amount, and not every state is going to be able to afford that," he said. "We believe this is a federal responsibility, and therefore the federal government should purchase it and stockpile it."

The TFAH-IDSA report also makes the following recommendations:

The Centers for Disease Control and Prevention should implement a nationwide, real-time system to track flu vaccine efficacy, distribution and redistribution, uptake, and impact.
The United States should boost surveillance for novel flu viruses by expanding working relationships with other countries, especially in Southeast Asia, through the World Health Organization.
The nation should embrace policies to increase seasonal flu vaccination in order to reduce the toll of flu and to stabilize vaccine manufacturing capacity. This should include developing "standardized templates for conducting mass vaccinations and countermeasure distribution."
The Food and Drug Administration (FDA) should streamline the licensing process for pandemic vaccines, using a different approach than with season flu vaccines.
The FDA should adopt criteria for accepting foreign clinical trial data for registering flu vaccines in the United States.

An additional recommendation, listed in a news release but not in the full report, is that Congress pass the proposed Pandemic and All-Hazards Preparedness Act to improve public health capabilities and support private-sector innovation.

The report was written by Levi and Neuzil with Marlene Cimons, an adjunct journalism professor at the University of Maryland's Philip Merrill College of Journalism.

In preparing the report, they drew on interviews with 14 leading experts on flu, pandemics, and infectious disease, including Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. The group also included Michael T. Osterholm, PhD, MPH, director of the University of Minnesota Center for Infectious Disease Research and Policy, publisher of the CIDRAP Web site.

Full TFAH-IDSA report
http://healthyamericans.org/reports/fluscience/FluScience.pdf