Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services (HHS), today announced the decision to spend $1 billion of existing funds on what a press release gingerly called “steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A (H1N1).”
The press release says HHS will spend the money on vaccine ingredients needed for commercial-scale production and for the early clinical tests needed to determine how much of this and how much of that to put into the final product. Specifically, influenza vaccines contain the hemagglutinin protein that studs the surface of the virus, the so-called antigen that stimulates the immune system to produce antibodies. In countries outside of the United States, vaccine makers add a booster, or adjuvant, to increase potency, which increases the amount of final product they can make from a given amount of antigen—or reduces the number of doses ultimately needed to trigger a robust antibody response. Although the U.S. Food and Drug Administration (FDA) currently does not license the use of any influenza vaccines that contain adjuvants, it has approved adjuvant-containing vaccines against many other diseases. (FDA does not license adjuvants, per se, but considers them as an integral ingredient of final products that use them.)
HHS spokesperson Bill Hall told ScienceInsider that the money will purchase 20 million doses of vaccine, the amount needed to protect “critical infrastructure personnel and vulnerable populations.” But the $1 billion only covers the cost of bulk ingredients, not a final product that is properly formulated, put into vials, and approved by FDA. And Hall stressed that there has been “no decision” about whether to go into full-scale production to make enough vaccine for the entire country's 304 million people.
Hall said three companies will receive two-thirds of the money to produce antigen and adjuvant: Novartis ($288.8 million), GlaxoSmithKline ($181.1 million), and Sanofi-Pasteur ($190.6 million). Sanofi-Pasteur will make only antigen, and Novartis and GlaxoSmithKline will make antigen and their novel, proprietary, “next generation” adjuvants—neither of which has ever been used in a vaccine that has received approval by FDA.
Another $150 million will go toward conducting clinical trials run by these three companies and MedImmune, in Rockville, Maryland, and CSL Limited, in Melbourne, Australia. Hall said the remainder will go to companies that still are negotiating with HHS.
“Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus,” said Sebelius in the HHS release. “The actions we are taking today will help us be prepared if a vaccine is needed.”