Novartis Delivers Influenza A Vaccine To US

Novartis has shipped over 7.5 million doses of Influenza A(H1N1) 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. The deliveries are in line with commitments made to the US Department of Health and Human Services (HHS), said the company.

Reportedly, to date, the company has produced 42 million units of vaccine. 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.

The company said that the production of the H1N1 vaccine is progressing, despite the unexpected very low yields observed with the initial seed virus at 23%, as compared to average yield seen with seasonal vaccines. Novartis has started production with a new seed virus in the middle of September which provides an improved yield of 63%.

In addition, the company is progressing with the production of its proprietary adjuvant MF59 for the US. Adjuvants have shown to be antigen sparing and can double the number of vaccine doses produced.

Andrin Oswald, CEO of Novartis vaccines and diagnostics, said: “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.

“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.”