The United States Department of Health and Human Services (HHS) is trying to cover all of its bases as it seeks to stockpile a vaccine to fight influenza A (H1N1). GSK and Sanofi are first on the list of drugmakers that will work with HHS to meet its objectives. Research scientists are also preparing for possible drug-resistant strains by making progress toward a new type of drug that will be able to stop the spread of infection and possibly prevent initial infection.
In accordance to an existing contract, HHS has placed an initial order, valued at $190 million, with Sanofi Pasteur for a vaccine. The order provides for the production of the bulk vaccine. However, the company is still awaiting the seed virus from the US Centers for Disease Control. Once the seed virus is obtained, the company says it will have a better timeline of when the vaccine might be available. Moreover, dosage requirements have not yet been determined and the final formulation, filling, and distribution of the vaccine have not yet been established. Sanofi Pasteur also says it “is prepared to commence commercial scale production in June following certification of the working seed by the US Food and Drug Administration.”
Meanwhile, HHS has also placed initial orders for influenza A (H1N1) antigen from GSK as well as the company’s proprietary AS03 adjuvant system, which the company already used in phase II trials of an adjuvanted influenza A H5N1 (avian flu) vaccine. According to a May 15 release, GSK says it is also waiting on a seed virus from the World Health Organization. The company claims it has also received “several orders from several governments” for an influenza A (H1N1) adjuvanted vaccine. The governments of France, Finland, Belgium, and the United Kingdom were listed in this release.
Perhaps future vaccine production will take a completely different approach. In a previous post, I questioned what would happen if the H1N1 virus became resistant to current antiviral drugs. Evidently, a team of researchers is already on their way to solving that potential problem. At Rensselaer Polytechnic Institute in Troy, NY, work is underway to test a new approach for combating the influenza A virus, including its possible mutations. In an announcement made May 19, scientists said they are seeing “promising preliminary results” of a chemical approach to targeting both the hemagglutinin (H) and neraminidase (N) outer protein components of the influenza A virus. Current influenza drugs target only the N portion, which disrupts the ability of the virus to leave an infected cell and infect other healthy cells. The new approach, based on “click chemistry,” targets the H protein, which prohibits entry into the healthy cell. The research team says they can manipulate the chemistry to target one or both components depending on the mutation (e.g., H1N1 associated with swine flu or H5N1 associated with avian flu).