Sanofi pasteur y la preparación contra una eventual
pandémia de grippe : Hechos y cifras
Sanofi pasteur, the vaccines division of the sanofi-aventis Group, is committed to global pandemic preparedness. As the world leader in research, development and manufacturing of influenza vaccine, sanofi pasteur is actively involved in projects in the U.S., Europe and worldwide, with the goal of developing a vaccine to protect against a pandemic influenza virus.
Sanofi pasteur is also investing in a major expansion of its influenza vaccine production capacity in the U.S. and also of its vaccine formulation and filling capacity in France (Val de Reuil facility).
In Europe, sanofi pasteur initiated and runs a large range of projects:
• In France, sanofi pasteur sponsored the first clinical trials of an H5N1 influenza vaccine candidate that compared vaccines with and without adjuvants [1].
• In France, sanofi pasteur was awarded a contract by the French Ministry of Health to produce a 1.4 million dose stockpile of the H5N1 candidate studied in the above-mentioned trial. Under this agreement, the company could also be called upon to provide enough vaccine to protect up to 28 million people in France in the event of a pandemic being declared, once the actual virus strain responsible is identified.
• In Italy, in February 2006, sanofi pasteur provided candidate H5N1 vaccine to the Ministry of Health and entered into an agreement to provide an actual pandemic strain vaccine, once a pandemic has been declared.
• In September 2006, sanofi pasteur generated the first clinical trial lot of a new generation of H7N1 pandemic vaccine. This trial will broaden sanofi pasteur’s pandemic preparedness program initiated with the development of H5N1 vaccines.
• In Austria, in October 2006, data from the first, phase 1 clinical trial with sanofi pasteur’s H5N1 pre-pandemic vaccine was presented at the International Conference for Influenza Vaccines. The data showed that the vaccine induces antibodies that neutralize recent H5N1 circulating viruses that were not included in the original vaccine formulation, further demonstrating the value of sanofi pasteur candidate vaccine for pandemic preparedness.
In the U.S., sanofi pasteur has a number of pandemic-related agreements with the U.S. government involving development of pandemic vaccine stockpiles, production of investigational doses and the development of cell culture technology, including:
• In May 2004, sanofi pasteur contracted with the U.S. National Institutes for Allergy and Infectious Diseases (NIAID) to produce investigational doses. The doses were shipped to the NIAID in March 2005. The studies were completed in 2005 and the results were published in New England Journal of Medicine [2].
• In September 2004, the company signed a contract with the U.S. Department of Health and Human Services (HHS) to produce two million doses of bulk vaccine derived from the H5N1 viral strain. The bulk doses were produced and are being stored and can be formulated and filled upon government request.
• In November 2004, the HHS awarded a contract to sanofi pasteur to expand and safeguard the egg supply needed to produce influenza vaccine and to formulate each year investigational doses for a potential pandemic influenza vaccine.
• In April 2005, the HHS awarded a contract to sanofi pasteur to accelerate the development of a cell-culture influenza vaccine in the U.S. and to design a U.S.-based cell-culture vaccine manufacturing facility.
• In September 2005, the HHS awarded a contract to sanofi pasteur to produce a vaccine to help protect against the H5N1 influenza virus strain. The $150 million contract calls for sanofi pasteur to manufacture the vaccine in bulk concentrate form at its U.S. headquarters in Swiftwater, PA. The agreement provides for additional fees to be paid to sanofi pasteur for storage of the vaccine as well as for formulation and filling of the vaccine upon government request.
• In February 2006, sanofi pasteur supplied NIAID with 15,000 investigational doses of H5N1 vaccine formulated with and without aluminum hydroxide adjuvant for use in NIAID-sponsored clinical studies.
• In November 2006, sanofi pasteur has signed a contract with the Office of Public Health and Emergency Preparedness, a division of HHS for the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine. This contract covers clade 2 of the H5N1 virus (A/Indonesia) for use in the U.S. government stockpile. The agreement is valued at up to $117.9 million the final value will depend on the number of doses that can be formulated from the bulk material).
In Australia:
• A contract has also been signed with the Australian government for the supply of vaccine in the event of a pandemic influenza outbreak.
References
[1] Bresson JL, Perronne C, Launay O, et al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006 May 20;367(9523):1657-64.
[2] Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immunogenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006 Mar 30;354(13):1343-51.
