HHS Awards Contracts for Pandemic Flu Vaccines

Washington, DC (Nov. 20)-The US Department of Health & Human Services (HHS, www.hhs.gov) awarded contracts totaling $199.45 million to three vaccine makers to manufacture 5.3 million 90-µg doses of influenza vaccine designed to protect against the H5N1 influenza virus strain.

The three awards include a $117.9-million contract for 3.7 million doses to Sanofi Pasteur (Lyon, France, www.sanofipasteur.com), a $40.95-million contract for 800,000 doses to Novartis (Basel, Switzerland, www.novartis.com), and a $40.6-million contract for 800,000 doses to GlaxoSmithKline PLC (GSK, London, www.gsk.com).

These new vaccine purchases supplement the existing stockpile of 5.9 million doses of H5N1 vaccine and build on HHS’s plans to buy enough vaccine for 20 million people. The additional vaccine will be placed in the Strategic National Stockpile.

Manufacturing projects detailed

Sanofi Pasteur’s contract covers the production of the bulk concentrate of a new type of H5N1 prepandemic vaccine: clade 2 of the H5N1 virus. Previous stockpile contracts covered the clade 1 form of H5N1. Clade 1 viruses circulated in Cambodia, Thailand, and Vietnam and were responsible for human infections in those countries. Clade 2 viruses circulated in birds in China and Indonesia and later spread to the Middle East, Europe, and Africa.

The H5N1 clade 2 bulk material is being manufactured from a seed virus provided by the US Centers for Disease Control and Prevention (Atlanta, GA, www.cdc.gov). The seed virus is a laboratory version of the wild-type virus.

Sanofi Pasteur says the bulk concentrate is currently being produced. Potency testing will be conducted over the next few months to determine the concentration of the bulk material.

Under its contract, GSK will manufacture and store bulk H5N1 antigen using its recently acquired production facilities in North America. GSK also may be directed by HHS to formulate this bulk antigen at some point in the future. In addition, HHS has the option to purchase prepandemic vaccines together with one of GSK’s proprietary adjuvant systems, which could mean that less antigen would be needed per dose to achieve a protective immune response.

Novartis will manufacture the prepandemic egg-based vaccine in 2007 at its facility in Liverpool, England, following the production of “Fluvirin” influenza virus vaccine for the 2007–2008 influenza season. The vaccine will be based on an inactivated H5N1 influenza strain.

Novartis also is manufacturing H5N1 vaccine at its other European facilities for stockpiling efforts of other countries. Earlier this year, Novartis submitted a mock-up file for pandemic influenza vaccine containing its MF59 adjuvant to the European Medicines Agency (London, www.emea.eu.int).

Novartis’s new contract with the HHS is in addition to two earlier vaccine projects awarded by the US government: a $62.5-million contract in October 2005 and a $220-million contract announced in May 2006 for developing and manufacturing a cell culture-derived influenza vaccine. Novartis is using part of the $220-million contract to support the planning and construction of new cell culture-derived influenza vaccines manufacturing plant in Holly Springs, North Carolina.