Novartis Vaccines started shipping the first of 30 million doses of its Fluvirin® seasonal influenza vaccine to the U.S., reportedly weeks ahead of schedule. The vaccine, which is indicated for patients aged four years and over, will be used to help meet the anticipated increase in demand for the seasonal vaccine as a result of the current global (A) H1N1 swine flu pandemic.
Fluvirin comprises antigens to the three influenza virus strains recommended by WHO for this year. These are A/Brisbane/59/2007, IVR-148 (H1N1); A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus); and B/Brisbane/60/2008.
Novartis shipment follows just days after AstraZeneca’s MedImmune said that it had also started shipping its seasonal influenza vaccine, FluMist, to distributors in the U.S.
Novartis started clinical trials with its swine flu H1N1 vaccine in July. The company has also initiated large-scale antigen production at all flu vaccine production sites in Europe, using both traditional egg-based manufacturing as well as its faster, cell-based technology. Using the cell-culture platform, first batches were successfully produced from both the wild virus strain and the “reassortant seed” modified virus recommended by WHO and health authorities, according to the firm. Current yields from the reassortant strain are lower than expected, however, and Novartis says that it is working to make adjustments necessary to improve these yields.
Novartis has been awarded two contracts from the U.S. government totaling $979 million for the future purchase of H1N1 bulk vaccine and its proprietary MF59 adjuvant. The company says that pending approval from regulatory authorities and yield improvements, it expects deliveries to start during the fourth quarter and continue into 2010.
Contracts with other countries including France, The Netherlands, and Switzerland have also been signed. Additionally, more than 30 governments have made requests for supply of influenza A (H1N1) vaccine ingredients. These include preexisting pandemic vaccine supply agreements and new requests for vaccines across all production platforms.
Medimmune, meanwhile, has won a $90 million contract from the U.S. government for its monovalent live attenuated influenza vaccine against A (H1N1). The company says it has successfully produced a master virus seed candidate for its A (H1N1) vaccine and estimates that it may be able to manufacture approximately 200 million bulk doses of FluMist A (H1N1) and fill approximately 40 million doses into nasal sprayers by March 2010.
Sanofi Pasteur recently estimated that it will have the first A(H1N1) vaccine doses ready for public health officials within four to six months pending regulatory approval. In July the company won a contract from the French government for the initial supply of 28 million doses of its A(H1N1) influenza virus vaccine in final presentation, with an option for an additional 28 million doses.
Glaxo SmithKline, meanwhile, received worldwide orders for 195 million doses of its adjuvanted H1N1 vaccine and says supplies should be available to governments from September onwards with shipments expected in both 2009 and 2010. The company is also tripling annual production capacity of its antiviral Relenza to 190 million treatment courses.
In Australia, CSL started trials of its H1N1 vaccine in July. The company has a commitment to the Australian Department of Health and Ageing for the supply of enough vaccination for up to 10 million people.