Companies receive HHS orders for novel flu vaccine

May 26, 2009 (CIDRAP News) –Two vaccine companies, Sanofi Pasteur and GlaxoSmithKline, recently announced they received their first orders from the US government for a vaccine and adjuvant to protect the country against the novel H1N1 virus.

Sanofi, in a statement released yesterday, said the initial order it received from the Department of Health and Human Services (HHS) covers the production of bulk vaccine and related activities and is worth $190 million. On May 22, Glaxo said in a press release that HHS ordered vaccine antigen and the company's proprietary adjuvant system, AS03. Adjuvants are compounds that enhance a vaccine's immune response, offering the possibility of stretching antigen supplies.

The announcements from the two companies follow a May 22 announcement from HHS that secretary Kathleen Sebelius was directing about $1 billion in existing funds toward clinical studies and commercial production of bulk vaccine antigen and adjuvant.

Federal officials have announced plans to support the development of a novel H1N1 vaccine, but have taken pains to explain that the decision to use it would be made separately.

The Centers for Disease Control and Prevention (CDC) has said it hopes to wrap up work on a seed strain to send to vaccine makers within the next few weeks. Once companies receive the seed strain, they can develop pilot lots to begin safety, efficacy, and dosage testing.

The federal government's placement of the orders falls under existing contracts that the Biomedical Advanced Research and Development Authority (BARDA) established with the companies in 2004 as part of the nation's pandemic influenza strategy.

Sanofi said it hopes to begin work on a pilot lot in June after the US Food and Drug Administration approves its working seed. The company said clinical trials could begin as early as August, but a timeline for final formulation, filling, and distribution has not been set.

Wayne Pisano, Sanofi's president and chief executive officer, said in the press release that though a number of complex steps need to be taken before a vaccine is available, the company's experience in developing the prepandemic H5N1 avian influenza vaccine will be helpful. "We look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from AH1N1," he said.

Production of the new H1N1vaccine for HHS will take place at the company's recently licensed new production facility in Swiftwater, Pa. As soon as the company finishes production of seasonal influenza vaccine at its second Swiftwater facility, it can produce the novel H1N1 vaccine at both plants. The two plants, when operating at full capacity, can make about 150 million doses of seasonal flu vaccine.

Meanwhile, Glaxo said it expects to fill HHS' adjuvant order within the next few months and hopes to produce the first antigen doses 4 to 6 months after receiving the novel H1N1seed strain. The company said its proprietary adjuvant, already approved as a component of the H5N1 vaccine in Europe and some Asian countries, is the subject of 15 additional clinical trials, including one involving a seasonal flu vaccine.

Both Sanofi and Glaxo said they are in ongoing discussions with other countries about producing novel flu vaccine for national stockpiles.

See also:

May 25 Sanofipress release

May 22 Glaxopress release

May 22 HHS press release

May 6 CIDRAP News story "FDA approves new vaccine facility"

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