US To Buy H1N1 Vaccines From Four Firms

FYI – The standard “aduvant” in flu vaccine is Thimerasol (mercury salts) and the preservative is formaldehyde.

(Updates with amounts of contracts and adds details throughout.)

Nasdaq.com
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The U.S. government signed contracts with four companies worth a total of almost $1 billion to purchase ingredients used to make vaccines against the new H1N1 influenza virus.

Health and Human Services Secretary Kathleen Sebelius said Monday that the department will commit $884 million to purchase supplies of two key ingredients for a potential H1N1 vaccine.

The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts with U.S. units of Sanofi-Aventis SA (SNY) and AstraZeneca Plc (AZN), along with GlaxoSmithKline Plc (GSK) and Novartis AG ( NVS). In May, the government earmarked $1 billion to spend on vaccine development. The bulk of the additional contracts announced Monday goes to Novartis with a contract worth about $690 million. Sanofi’s contract is worth about $61.4 million; Glaxo’s totaled $71.4 million while a contract signed with AstraZeneca’s MedImmune unit totals about $61 million.

Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus, HHS said. An adjuvant boosts the body’s response to a vaccine and could potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.

The government said vaccine ingredients will become a part of the pandemic stockpile, for use if a vaccination campaign is necessary. Last week, federal officials said they were planning for a vaccination campaign aimed at school-age children, the age group among the hardest hit by the new virus that was first detected in April. Vaccinating health-care workers would also be a top priority.

Any H1N1 influenza vaccines would be administered separately from seasonal influenza vaccines because production is almost complete for seasonal vaccines.

Vaccine makers are currently developing H1N1 influenza vaccine pilot lots that would be used for tests that are expected to start next month. The Food and Drug Administration is planning a meeting next week to discuss the clinical trials.

The earliest doses of an H1N1 influenza vaccine wouldn’t be available until mid-October and that’s assuming clinical tests show the proposed H1N1 vaccines are safe and likely to be effective.

Federal officials have said they expect tests and the manufacturing process of H1N1 vaccines would be similar to the process for seasonal vaccines. Any H1N1 vaccine campaign would likely be carried out over a several-week period as additional vaccine becomes available. Initially the government is expected to control the vaccine supply and could partner with local health departments and schools to deliver the vaccine.

Separately, a new study of the H1N1 virus published online in the journal Nature Monday suggests the virus is stronger than previously believed. Research led by Yoshihiro Kawaoka of the University of Wisconsin in Madison, showed the H1N1 virus infects the lungs of mice, ferrets and monkeys, making the virus more likely to cause pneumonia compared to seasonal flu, which typically infects cells in the sinuses and throat. Researchers said tests of antiviral drugs in mice showed the drugs worked and suggested the drugs will be effective at combating H1N1 infections in humans.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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