The current government plan for production of the vaccine for pandemic flu does not reflect the urgency of the problem nor the critical leadership it deserves. In a report released today, Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program, the Project On Government Oversight calls on Congress to demand answers as to why the Administration has not moved to name a permanent director for the Biomedical Advanced Research and Development Authority (BARDA). It was created within the HHS by an act of Congress over a year ago. In addition, a lack of sufficient disclosure has surrounded the program to date.
BARDA’s mission is to facilitate collaboration between government, industry, and academia in the influenza vaccine program and other programs dealing with public health emergencies.
In a letter sent today to key congressional leaders, POGO Executive Director Danielle Brian said, “The report highlights serious flaws in the current government plan for the production of a pandemic flu vaccine.”
“The failure to appoint a permanent director of sufficient stature who can marshal the international scientific and business community and other key players to speed up a viable vaccine production program is inexcusable and dangerously short-sighted,” said Dr. Ned Feder, POGO science advisor and former scientist at the National Institutes of Health.
In July 2007, Health and Human Services Secretary Mike Leavitt announced that, over the next five years, vaccine manufacturers will develop the capacity to produce and deliver enough vaccine for the American public within six months of the appearance of a pandemic virus.
Secretary Leavitt’s prediction may be overly optimistic. But even if it’s not, it will be 2012 before manufacturers are fully ready for a pandemic, according to Secretary Leavitt, and another six months after the start of a pandemic before they can produce enough vaccine.
In addition to stronger leadership, POGO strongly recommends that the HHS Secretary or the director of BARDA require the prompt disclosure of all relevant documents in the pandemic flu vaccine program, including the level of U.S. dependence on foreign sources of material for vaccine production.
“Without such scrutiny, problems and possible improvements to the program may not be discovered until too late. For instance, the government’s current timetable for vaccine production may not be the best that can be reasonably expected, but only through full disclosure of all elements related to production, and through the resultant debate can we know” the report states.