MAY 23, 2009

For Flu Vaccine, U.S. Sets Aside $1 Billion

By BETSY MCKAY

The U.S. government is setting aside $1 billion to launch development of an H1N1 swine flu vaccine, as the disease continues to spread around the globe and its future course and severity remain unknown.

Health and Human Services Department Secretary Kathleen Sebelius shows a child from the HHS daycare how to wash his hands as Sesame Street character Elmo looks on on May 22, 2009 in Washington, DC.
The money, which comes from existing federal funding for pandemic flu and preparedness, will be used both for clinical studies this summer and for the production of two bulk ingredients that will be placed in a federal stockpile to be used if officials decide to go ahead with a large-scale vaccination program, the Department of Health and Human Services said Friday.

The move marks a significant step toward making a vaccine that would protect people against the spreading new flu virus, but doesn't mean the government will definitely go ahead with mass production of shots. "The actions we are taking today will help us be prepared if a vaccine is needed," HHS Secretary Kathleen Sebelius said.

The move also helps alleviate the risk manufacturers are taking on by producing ingredients for a vaccine that may or may not end up being used. HHS said it is placing orders for the ingredients with manufacturers with which it already has contracts to produce a pandemic vaccine -- contracts that were focused on the possibility of a pandemic of H5N1 avian flu. More than $3 billion in federal funds in the past four years have gone toward developing, building manufacturing and stockpiling a vaccine to fight that disease, which is much deadlier than the new H1N1 virus, but hasn't spread widely among humans.

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Novartis AG will receive $289 million, Sanofi Aventis SA will receive $191 million, and GlaxoSmithKline PLC will be given $181 million to produce H1N1 vaccine ingredients. HHS said it is also talking to additional manufacturers to find more capacity.

Another $150 million will go to these manufacturers and others to produce pilot lots of vaccine and to pay for the clinical studies in which they will be used. The clinical studies will determine whether the vaccine is safe, the proper dose and whether adjuvants are needed -- an ingredient that improves the immune system response, reducing the amount of active ingredient needed for the vaccine.

Scientists at the Centers for Disease Control and Prevention are analyzing two candidate viruses that could be used to make a vaccine, and plan to send one or both to manufacturers by the end of next week, so they can begin making pilot lots.

The new H1N1 flu had reached 42 countries as of Friday, with 11,168 cases confirmed by laboratory tests, and 86 deaths, according to the World Health Organization. The U.S. had 6,552 confirmed and probable cases in 48 states and Washington, D.C., with nine deaths, according to the CDC.

Under pressure from health officials around the world, the WHO said Friday it would alter its criteria for declaring a pandemic, to take into account not only the geographic spread of the disease, but also its severity. The WHO's pandemic alert currently stands at level 5, or one notch short of a pandemic, a sign to countries from the United Nations public-health agency that a pandemic is imminent. But the disease has been relatively mild thus far.

WHO's chief, Margaret Chan, warned again Friday that the disease could easily become more lethal as it spreads, calling it a "subtle, sneaky virus" as she closed a weeklong meeting of global health officials.

Keiji Fukuda, the WHO's flu chief, said the agency would take its lethality into account in evaluating whether to move the pandemic alert up to its highest notch. "What we will be looking for is events which signify a really substantial increase in risk of harm to people," he said.

Write to Betsy McKay at betsy.mckay@wsj.com