HHS admits overstating flu-vaccine availability

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By Ann Geracimos

Two top officials at the Department of Health and Human Services acknowledged to a congressional panel Wednesday that the government had overpromised and made poor judgments on vaccination production against the current H1N1 flu pandemic.

The government's initial plan was to have 160 million doses available in October; the actual production at month's end was barely 15 percent of that -- 24.8 million doses.

"In hindsight, it's clear we should have been more skeptical," Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, said of the government's consistently overstated estimates on the amount of vaccine that would be ready for public distribution.

Dr. Frieden spoke before a meeting of the House Appropriations subcommittee on labor, health and human services, education and related agencies, in response to concerns by Rep. David R. Obey, Wisconsin Democrat and the panel's chairman, about why production of supplies had been so slow and what needed to change for the future.

Dr. Frieden attributed the shortfall to the unpredictable rate of growth of the flu virus in egg cultures that are used to make the vaccine. In effect, the government failed to properly count its chickens -- or eggs -- before they hatched.

"The original estimate was based on our collective experience of the flu. We were optimistic," admitted Dr. Nicole Lurie, Health and Human Services assistant secretary for preparedness and response.

Under repeated questioning, neither Dr. Frieden nor Dr. Lurie would predict when there will be enough vaccine necessary to inoculate the population groups that CDC has recommended be first in line, including pregnant women, health care workers and people who take care of children.

"We focus on one week at a time," Dr. Frieden said.

"You must have some estimate," said Mr. Obey, interrupting him.

Dr. Lurie responded: "We have worked extremely hard with the manufacturers -- to be quite honest, flu is really unpredictable, and so we are hesitant about the future because anything could happen ... creating more expectations is difficult."

When asked about the future expense of a vaccine program based on advanced cell-based technology -- theoretically, a more reliable method, but one still in the experimental stage and in which the federal government has invested - Dr. Lurie said, "We are not sure at this point."

Because of the unexpected appearance of a new strain, vaccine preparation was ramped up, explained Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

A process that normally begins in January, "predicting with an educated guess of the flu strain for next season," took place in April, using tried-and-true technology to ensure safety of the vaccine.

"You really can't do anything with a virus that isn't growing well," Dr. Fauci said.

Wednesday morning's well-attended session provided panel members with a basic education on one of nature's least obedient forms - the influenza virus, the nature of which scientists acknowledge they are just beginning to understand.

"We still don't understand how flu vaccine fully protects people," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said in a telephone interview.

"What we need to know is how to make a better vaccine that results in other parts of the immune system helping to support overall protection. What are the parts of the virus we respond to, and how do we respond to it?"