U.S. Steps Up H1N1 Readiness

The Department of Health & Human Services has set the wheels in motion to create a vaccine against the H1N1 virus in time for the fall flu season. Although the government is still months away from deciding whether to recommend widespread inoculation, HHS has released $1 billion to several drug companies to make the starting materials for about 20 million doses of swine flu vaccine.

In the first of what it expects to be a series of orders, Sanofi-Aventis got a $190 million contract to make the bulk vaccine at its newly approved facility in Swiftwater, Pa. GlaxoSmithKline got $180 million to manufacture both the vaccine and an adjuvant system, which can help bolster immune response to the vaccine.

Novartis received a $290 million contract. AstraZeneca's MedImmune subsidiary and the Australian biopharmaceuticals firm CSL both received contracts to develop pilot lots of a vaccine.

In addition, the government released the seed strain of the virus to companies last week. According to Sanofi, the first step will be to coax the virus to grow at the ideal yield in a production setting, a process that is expected to take two weeks. Next, companies will prepare for large-scale production, should the government give the green light.

The HHS funds also cover clinical studies of the vaccine to ensure its safety, determine the levels of vaccine needed to provide immunity, and assess whether adjuvant will need to be added to the mix.

Although HHS has ordered the main ingredients of the vaccine, officials have yet to make the decision to scale up to full production. The flu outbreak has not been as widespread as initially feared. The World Health Organization has confirmed about 13,500 cases of swine flu and 95 related deaths worldwide. By comparison, some 36,000 people in the U.S. alone die each year from illnesses related to seasonal flu.

But experts are concerned that the H1N1 virus could become more lethal. Unlike with seasonal flu, human immune systems don't have a memory response to the new virus, explains Suresh K. Mittal, interim head of comparative pathobiology at Purdue University's School of Veterinary Medicine. Worse, influenza viruses tend to mutate slowly in swine but evolve more quickly in humans. One fear, Mittal adds, is that the seed virus just distributed by the government may not match the strain circulating in the fall flu season.

U.S. health officials are keeping a close eye on how the flu outbreak progresses in the Southern Hemisphere, where winter is beginning. Anne Schuchat, interim deputy director for science and public health at the Centers for Disease Control & Prevention, says officials will be monitoring whether the virus becomes more resistant to existing antiviral drugs and more transmissible. They will make a decision about widespread immunization by late summer or early fall, she says.