Global Insight Perspective | |
Significance | Sanofi Pasteur has become the first company to have a vaccine against the H5N1 strain of bird 'flu licensed by the U.S. FDA. |
Implications | The licensing will kickstart a supply deal that will see Sanofi Pasteur supply bulk concentrate of the vaccine for use in the U.S. government's emergency stockpiles. However, the FDA itself has admitted that the H5N1 vaccine is nowhere near as efficient as it should be, and the licensing decision was made out of necessity and a lack of existing alternative vaccines. |
Outlook | While the licensing is a major milestone for Sanofi Pasteur, the United States will be keeping an eye out for new developments in the field that could prove to be more effective, with GSK being a potential rival. Even so, it is likely to be several years before a suitable candidate is found. |
Sanofi Pasteur is celebrating a significant achievement today, as the U.S. Food and Drug Administration (FDA) has agreed to license the company's vaccine against the deadly H5N1 viral strain of avian influenza (bird 'flu). The serum, known for now simply as the H5N1 vaccine, has been developed as a protective treatment for people at increased risk of contracting bird 'flu in the event of a pandemic outbreak of the disease. Sanofi Pasteur, a unit of leading French pharmaceutical company Sanofi-Aventis, had jointly submitted a Biologics License Application (BLA) for the H5N1 vaccine with the U.S. National Institutes of Health (NIH). Under a pre-existing agreement with the U.S. government, all U.S. supplies of the vaccine will be produced in the United States and held in emergency stockpiles until needed. In its current form, the H5N1 virus is transmissible from poultry to humans, but has not yet mutated into a form that can be easily transmitted from human to human. If and when this occurs, the spread of the disease could reach pandemic levels, and the U.S. government is one of many around the world that has taken the precaution of securing emergency stockpiles. Where the U.S. differs from the rest of the world is that it is the only country to have been able to secure a deal, whereby production facilities of the vaccine will be based in the country as well, rather than having to depend on drugs imported from elsewhere (see France: 21 November 2006: Sanofi Pasteur to Supply U.S. with Stockpile Quantities of H5N1 "Pre-Pandemic" Vaccine).
The FDA's licensing of the H5N1 vaccine comes despite recent controversy over whether the product is, in fact, effective. A study published in the New England Journal of Medicine last year found that it requires six times the normal dose and two administrations several weeks apart in order to produce an immune response, and even then, the vaccine produced the desired immune response in only 54% of the people tested (see France: 30 March 2006: Study Questions Efficacy of Sanofi-Aventis' Avian 'Flu Vaccine). The FDA itself had expressed doubts over the vaccine earlier this year, this time questioning the product's safety given that less than half the people on whom the vaccine was trialled were able to produce enough antibodies to protect against H5N1 (see France: 27 February 2007: U.S. FDA Casts Doubts over Sanofi-Aventis' Bird 'Flu Vaccine Ahead of Panel Review). In the end, however, the FDA's final decision was coloured by the lack of alternative vaccines at a similar stage of development (see France: 28 February 2007: U.S. FDA Advisory Panel Backs Sanofi-Aventis' Bird 'Flu Vaccine). In announcing the FDA's decision to license the H5N1 vaccine, Sanofi Pasteur has remained purposely vague as to the clinical trial results that were used to support the product's BLA, saying only that "the vaccine elicited an immune response against the H5N1 virus and was associated with mild side effects".
Outlook and Implications
Sanofi Pasteur MSD—Sanofi-Aventis's joint vaccines venture with U.S. drug heavyweight Merck & Co—yesterday announced that it was gearing up to invest millions in expanding its bird- 'flu production facilities in France (see France: 17 April 2007: Bird-'Flu Vaccine Production Set for Boost as Sanofi Pasteur to Invest US$271.1 mil. in Plant Upgrade). Today, in a press release, Sanofi Pasteur said that it has also invested significantly in boosting its production capacity for the H5N1 vaccine in the United States, which will now be crucial as the stockpiling contract between the French company and the United States. really gets under way. Sanofi's H5N1 vaccine remains the most advanced of any such product currently in development, but its well-documented shortcomings mean that the FDA will remain on the lookout for other companies nearing the finishing line. The United States will doubtless be following closely the recent talks between U.K. drug company GlaxoSmithKline and the World Health Organization (WHO), over ways in which to boost GSK's role in supplying vaccines against the H5N1 strain of bird 'flu to countries less able to invest in expensive vaccine stockpiles. Dutch biotech Crucell is also among the firms racing to develop a successful vaccine, although it will be some years before a potential candidate is ready for market approval (see Netherlands: 5 April 2007: Crucell Awarded EU Grant for H5N1 Vaccine Development). Sanofi Pasteur's supply deal with the Office of Public Health and Emergency Preparedness, which is part of the U.S. Department of Health and Human Services (HHS), is valued at US$117.9 million.