Swiss drug maker Novartis AG (NVS), Tuesday said, half of the currently approved U.S. dose of its influenza A (H1N1) 2009 unadjuvanted vaccine fulfilled protection criteria in adults and the elderly. Citing interim data from ongoing clinical trials, it further noted that the vaccine output to the U.S. could be quadrupled, if supplemented by its adjuvant.
Novartis revealed interim data that showed a single 7.5µg dose of the company's influenza A 2009 un-adjuvanted vaccine proved effective in protecting adults and elderly against the pandemic. Current U.S. guidelines necessitate a 15µg dose.
The data were generated mid-way in clinical studies conducted in 4,080 U.S. subjects by the company to evaluate immunogenicity, safety and reactogenicity of the company's vaccine and its MF59 adjuvant-supplemented doses.
Also, a 3.75µg dose of MF59-adjuvanted A 2009 vaccine met serologic protection criteria against influenza A in children ages 3 to 8, adults ages 18 to 64, and the elderly, according to the test results. An adjuvant is a vaccine-stimulant that enhances the body's immune response to the biologic.
The company noted that the entire vaccine production output from its Liverpool, U.K.-based flu manufacturing facility was dedicated to the U.S. since the emergence of the influenza disease caused by pandemic A.
Andrin Oswald, chief executive officer of Novartis Vaccines and Diagnostics, commented, "These promising data suggest that many more people could potentially be vaccinated with our current vaccines supply, protecting more people earlier against the current pandemic".
Novartis added that reducing antigen content per dose in the vaccine will be possible only after additional statistical analysis suggested by the U.S. FDA were satisfactory.
NVS is currently trading at $53.39, down 65 cents or 1.20% on the NYSE.
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