Novartis announces positive clinical trial results for novel H7N9 vaccine

•  85% of subjects immunologically protected after receiving second dose of investigational cell culture vaccine when combined with proven MF59® adjuvant
• Vaccine now in large scale production highlighting rapid response capability of novel FDA licensed cell culture technology
• 135 confirmed cases and 45 deaths from H7N9 virus since emergence in March according to the World Health Organization¹

Novartis announced today interim results from a Phase 1 clinical trial with its proprietary cell culture vaccine for the H7N9 avian influenza virus involving 400 healthy volunteers (18-64 years of age). The data shows 85% of subjects achieved a protective immune response after two doses of the 15 ug MF59 adjuvanted vaccine. Only 6% of subjects achieved a protective response when given two doses of the 15ug un-adjuvanted vaccine. The full data set from the trial will be submitted to a peer-reviewed journal for publication in the near future.

The vaccine was produced utilizing full-scale cell-culture manufacturing technology, an alternative technology that can significantly accelerate vaccine production versus traditional egg-based methods.² Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.³

“This rapid response underscores our leadership position in pandemic preparedness” said Andrin Oswald, Division Head, Novartis Vaccines. “Thanks to our investments into innovative production technologies and adjuvants, we are now able to offer a protective solution for a potentially deadly pandemic virus within a few months after the emergence of the H7N9 virus.”

Reports of H7N9 infection first emerged in China in March 2013. Novartis, along with its partners at the Craig Venter Institute, first synthesized the viral strain several days after it was shared with global researchers by the Chinese Centers for Disease Control. Novartis then produced clinical trial lots, began clinical trials in August, and initiated large-scale production in its Holly Springs (NC), USA and Marburg, Germany facilities in October.

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 No. HHSO1002012000141

References

1. www.who.int/influenza/human_animal_interface/influenza_h7n9/en/index.html
2. U.S. Department of Health and Human Services. “HHS Awards Contracts Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine.” 2006 Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html.
3. Ambrozaitis, Arvydas et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. Vol 27. Issue 43. October 9, 2009: 6022-6029. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. Accessed on October 3, 2012.