HHS Takes $1 Billion “Step” Toward Making Swine Flu Vaccine
May 23, 2009 by fluoutbreak
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.)




