Three large companies will get the lion's share of the federal government's first $1 billion in spending on development of vaccine for the emerging novel strain of influenza.

The HHS contracts provide Novartis with $288.8 million and GlaxoSmithKline with $181.1 million to produce antigens and adjuvants, and Sanofi Pasteur with $190.6 million to produce antigens.

Another $150 million in contracts have gone to those three companies, plus MedImmune and CSL Ltd., for test lots, clinical studies and potency testing. How the money is distributed among the firms was not released.

HHS is continuing to negotiate contracts for the approximately $190 million in remaining funds for flu production.

Even if a vaccine is produced, the government may not recommend that it be administered (¹ Also see "Vaccine For Swine Flu Faces Multiple Decision Points By Government" - Pink Sheet, 4 May, 2009., p. 3).

In addition to this funding, concern about the new flu strain could produce funding that companies can use for longer-term improvements of their facilities (see ² Also see "Flu Vaccine Funds From Gov’t Could Help Firms Upgrade Production Facilities" - Pink Sheet, 25 May, 2009.).

"The U.S. government will share as much information as possible from the results of these clinical studies with the World Health Organization and the global community so that other countries can benefit from the U.S. efforts to determine dosage, safety and effectiveness," HHS said in a May 22 release.

The potential H1N1 flu pandemic was a major topic at the World Health Organization General Assembly in Geneva May 18-22, and the importance of vaccine production capacity was underscored by a recommendation from a strategic advisory group of experts on H1N1 that a vaccine for the new flu strain not piggyback onto the seasonal flu vaccine.

Because of significant regulatory implications, the panel said a monovalent H1N1 vaccine is the preferred option at this time.

GlaxoSmithKline reported May 15 that it is discussing with European authorities the use of a mock-up dossier to get faster registration of an adjuvanted H1N1 vaccine. The company used that route last year to a European license for an H5N1 avian influenza vaccine.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Novartis Wins Top Share Of HHS’ Initial Pandemic Flu Vaccine Contracts

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