Environmental Protection

U.S. Orders More Vaccine from Pharmaceutical Companies

The U.S. Department of Health and Human Services (HHS) placed an order for an additional 29 million doses of its live attenuated influenza vaccine (LAIV) against the 2009 H1N1 influenza virus, according to MedImmune, the worldwide biologics business for AstraZeneca PLC.

This brings HHS orders to date to more than 40 million vaccine doses, with a total cumulative contract value of approximately $453 million. Previous HHS orders for approximately 13 million doses of LAIV for the 2009 H1N1 strain were placed in May and July.

The vaccine received approval from the U.S. Food and Drug Administration on Sept. 15 and is indicated for the active immunization of individuals 2-49 years of age against influenza caused by pandemic (H1N1) 2009 virus.

The company's development of LAIV for this strain of H1N1 began at the end of April, when it received the novel virus from the U.S. Centers for Disease Control and Prevention (CDC). Enough bulk vaccine to fill all orders placed by HHS has already been manufactured and about 3.4 million doses have been released. Distribution will occur at the direction of public health authorities.

"At MedImmune, our mission is to develop and deliver medicines that change lives, and we are proud that our innovative LAIV technology may help protect the public from the threat of 2009 H1N1 influenza," said Tony Zook, president. "We will continue to work collaboratively with the U.S. government and public health authorities to contribute to the response to this unpredictable infectious disease."

LAIV contains live vaccine virus strains that are weakened so as not to cause the flu. It is delivered into the nose, where the influenza virus usually enters the body, rather than by injection. LAIV prompts the body to begin mounting an immune response after the first dose.

The intranasal vaccine is not right for everyone. It must not be given to:

  • people with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine;
  • people with life-threatening reactions to previous influenza vaccinations; and
  • children and adolescents receiving aspirin or aspirin-containing therapy.

Children less than 24 months of age are not eligible for this vaccine.

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, received an additional order from HHS for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose. To date, the company has committed to 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.

"We are pleased to be able to support the U.S. government's pandemic response efforts through the production of additional doses of A (H1N1) vaccine," said Wayne Pisano, president and chief executive officer. "As the only company manufacturing inactivated influenza vaccine in the United States, we recognize the important role Sanofi Pasteur serves in the country's pandemic response plan and we have committed our resources to responding to our public health needs."

Sanofi Pasteur began commercial production of the new influenza vaccine in June using the novel virus strain to provide doses for clinical trials and to respond to the initial order from HHS. The company is testing the immunogenicity and safety of the Influenza A (H1N1) 2009 Monovalent Vaccine through clinical trials, which began on August 6. Final data from these clinical trials will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.

Sanofi Pasteur operates influenza vaccine production facilities in the U.S. and in France. Production of the new A (H1N1) vaccine for HHS is being performed at the company's U.S.-based production facility.

HHS also has released a request for proposals for the supply of intravenous peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization.

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. It has been studied in patients with complicated and uncomplicated influenza.

The agent was discovered by BioCryst Pharmaceuticals.

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