HHS awards 3 contracts for more H5N1 vaccine

Nov 20, 2006 (CIDRAP News) – The US government today announced the awarding of three contacts to buy enough additional H5N1 avian influenza vaccine to immunize almost 2.7 million people, at a cost of $199.45 million.

The Department of Health and Human Services (HHS) said the contracts are for a total of 5.3 million 90-microgram (mcg) doses of vaccine. The awards include $117.9 million to Sanofi Pasteur for 3.7 million doses, $40.95 million to Novartis for 800,000 doses, and $40.6 million to GlaxoSmithKline (GSK) for 800,000 doses.

HHS said last week that the existing national stockpile of pre-pandemic vaccine is enough to vaccinate about 3 million people with two 90-mcg doses each. The stockpile contains 7.3 million doses, but about 1.4 million doses have begun to lose potency, leaving 5.9 million doses of full-strength vaccine.

"These newest vaccine purchases supplement the existing stockpile of 5.9 million doses of H5N1 vaccine and build on the department's plans to buy enough vaccine for 20 million people," HHS said in a news release.

Sanofi Pasteur said its new contract is for a vaccine based on a clade 2 (subgroup 2) H5N1 virus. The existing stockpile is based on clade 1 viruses, which circulated and caused human cases in Thailand, Vietnam, and Cambodia in 2004 and 2005. Clade 2 viruses circulated in birds in China and Indonesia in 2003-04 and spread to the Middle East, Europe, and Africa in 2005 and 2006.

In a pandemic planning update last week, HHS noted its intention to begin stockpiling vaccine based on clade 2 viruses, out of concern that a vaccine based on one clade won't work well against a pandemic strain stemming from a different clade.

Today's announcement comes less than 3 weeks after experts assembled by the World Health Organization cautioned governments against rushing to stockpile pre-pandemic flu vaccines, saying too many scientific uncertainties remain. They said vaccines that work against one clade may not work against others and that the level of measured immune response representing adequate protection is unknown.

Although today's HHS announcement spoke of 5.3 million doses of vaccine, some statements from the vaccine manufacturers seemed to imply that the actual number of doses and the amount of antigen per dose are not yet certain.

Sanofi Pasteur, which has a vaccine plant in Swiftwater, Pa., said its new contract is worth "up to $117.9 million," the final amount depending on the number of doses that can be made from the bulk vaccine. "The bulk concentrate is being produced now," the company said. "Potency testing will be conducted over the next few months to determine the concentration of the bulk material."

Sanofi previously won a $13 million contract in September 2004 to make 2 million doses of H5N1 vaccine. In September 2005 the company won what was then listed as a $100 million contract to make more of the vaccine. Today's company statement said that contract is worth $150 million.

Novartis will make the H5N1 vaccine at its plant in Liverpool, England, in 2007 after production of next year's seasonal flu vaccine is finished, the company said in a statement.

"The US government will determine the dosage and formulation of the final product, including potentially adding an adjuvant such as MF59, at a later date," the statement said.

Earlier this year Novartis acquired Chiron Corp., which had won a $62.5 million H5N1 vaccine contract award from HHS in October 2005.

A GSK statement said the company would make bulk H5N1 antigen at its "recently acquired production facilities in North America." A Canadian Press report today quoted a company official as saying the vaccine would be made at a plant in Ste-Foy, Quebec.

Under the contract, GSK said, HHS may require that the vaccine include an adjuvant, which could reduce the amount of antigen needed per dose. The company said in July that preliminary results of a clinical trial of an H5N1 vaccine with a novel adjuvant looked promising.

See also:

Nov 20 HHS news release
http://archive.hhs.gov/news/press/2006pres/20061120.html

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