Novartis has shipped over 7.5 million doses of Influenza A(H1N1)[1] vaccine ready to use and expects 25 to 30 million doses of unadjuvanted vaccine to become available in pre-filled syringes and multi-dose vials by the end of November. Smaller changes in delivery timelines and volumes can result out of the variability of the underlying biological production process. The deliveries are in line with commitments made to the US Department of Health and Human Services (HHS). In addition, the company is progressing with the production of its proprietary adjuvant MF59(TM) for the US. Adjuvants have shown to be antigen sparing and can double the number of vaccine doses produced.
"Overall, we are pleased with the progress achieved to date, given the many challenges and uncertainties of the current pandemic. Not only did we complete our commitment to provide seasonal vaccine ahead of schedule, we are making every effort to make as much H1N1 vaccine available as quickly as possible," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "However, we acknowledge the limitations of the old manufacturing sites and technologies for influenza vaccines to rapidly respond to the needs of a pandemic. Over the last three years, Novartis has made major R&D investments to develop new technologies. And in partnership with HHS, we are building the first cell based flu manufacturing facility in the US. The opening of the site is planned later this year."
Production of the H1N1 vaccine is progressing, despite the unexpected very low yields observed with the initial seed virus at 23 percent as compared to average yield seen with seasonal vaccines. Novartis started production with a new seed virus in the middle of September which provides an improved yield of 63 percent. To date, 42 million bulk units of vaccine have been produced. The company expects to complete production of 90 million doses of bulk antigen by December and will continue to rapidly fill-finish the bulk antigen as it is produced and ordered by HHS.
Novartis is fully utilizing its manufacturing capacity and has entirely dedicated one of its two major flu manufacturing sites, based in Liverpool, U.K., to supplying H1N1 vaccine antigen for the US. Production capacity at the Liverpool site has been maximized by hiring and training 300 additional staff, as well as the acceleration of the opening of a new facility and egg incubation unit at the site. Following a more than USD 200 million investment over three years, the additional facility was recently approved by the US Food and Drug Administration (FDA) as suitable to manufacture vaccines for the USA.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
[1] This project has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract Number HHSO100200800072I.