May 22 (Bloomberg) -- The U.S. government is ordering about $811 million of components and tests of a swine flu vaccine for stockpiles to protect health-care workers along with children and other vulnerable people.

The orders were placed with GlaxoSmithKline Plc, Novartis AG, CSL Ltd., MedImmune Inc. and Sanofi-Pasteur, said Robin Robinson, director of the Biomedical Advanced Research and Development Authority, part of the Health and Human Services Department, in an interview today. Enough vaccine may be produced to protect 20 million people, said Bruce Gellin, director of the national vaccine program.

The order for components that can be made into a vaccine, if necessary, was placed in anticipation of the World Health Organization’s distributing seed lots of the virus to manufacturers by the end of this month, Robinson said. Forty-two countries have confirmed 11,168 cases, including 86 deaths, according to WHO’s latest tally. Almost four of every five cases were in Mexico and the U.S., where the new virus strain, a variety of H1N1, was discovered last month.

“The order we’re placing today starts the pipeline to fill our vaccine stockpile,” U.S. Health and Human Services Secretary Kathleen Sebelius said today at a news conference in Washington.

Decision in Summer

The decision whether to formulate a vaccine from the parts will be made during the U.s. summer, which begins next month, as health authorities watch the progress of H1N1, Robinson said.

Sebelius said the U.S. needed to take steps to have a vaccine ready though questions remain, including whether the virus seed strains will grow well enough to make an effective medicine. Other uncertainties include how much vaccine will be needed, how big a dose people should receive and who would get it.

“We can’t wait for answers to these questions,” Sebelius said. “We continue to stay one step ahead of the virus.”

The U.K., France, Belgium and Finland said May 15 they agreed to buy 158 million shots of the vaccine from London-based Glaxo and Baxter International Inc. of Deerfield, Illinois.

Robinson said HHS is asking for the H1N1 vaccine from the five companies with contracts to produce a vaccine needed in a flu pandemic.

Contract Awards

Novartis, of Basel, Switzerland, received a $288.8 million order, London-based Glaxo got $181.1 million and Sanofi-Pasteur, a unit of the French drugmaker Sanofi-Aventis SA, was awarded $190.6 million, said Bill Hall, a department spokesman, in a telephone interview. The orders are part of the companies’ vaccine contracts, he said.

HHS asked Novartis and Glaxo to produce antigen, which is the active ingredient in a vaccine that triggers the body to fight an invading virus, Hall said. The two companies also were asked to make adjuvant, an immune system booster. Adding adjuvant to a vaccine reduces the amount of antigen needed and extends the supply, he said.

Sanofi-Pasteur has been asked to make antigen only.

U.S. health officials have placed an additional $150 million order with the three companies, MedImmune Inc. and CSL Ltd. of Australia. That order is to develop test lots of vaccine for clinical studies to determine the required dose and antigen levels. The order also will cover potency testing for the vaccine. AstraZeneca Plc of London bought Gaithersburg, Maryland-based MedImmune in 2007.

Clinical Trials

Gellin, of the national vaccine program, said clinical trials conducted during the summer will answer questions for U.S. health authorities such as the correct dosage. That process should take until early fall in the U.S., he said in an interview. After that, the vaccine would be put in vials and tested again.

Gellin estimated that testing the vials would be an additional “three- to four-week process.”

More than 60 percent of the U.S. swine flu cases have been among those ages 5 to 25, according to the U.S. Centers for Disease Control and Prevention, based in Atlanta. The influenza has spread among school children, triggering the current closures of about 60 schools affecting 42,000 students, the CDC said today.

Sebelius made the vaccine announcement at the health department’s Childcare Center in downtown Washington, where she presented a new public service announcement for children and families about protecting themselves from H1N1.

To contact the reporter on this story: Nicole Gaouette in Washington at ngaouette@bloomberg.net.

Last Updated: May 22, 2009 17:35 EDT