Novartis swine-flu jab effective in single dose
pharmafile | September 3, 2009 | News story | Manufacturing and Production, Research and Development, Sales and Marketing |Â Â Novartis, h1n1Â
A study of Novartis' pandemic swine-flu jab shows it is potentially protective after just one dose, which could help eke out supplies for mass immunisation across the globe.
Other companies making the H1N1 vaccines, such as GlaxoSmithKline, have said two doses must be given as general practice for optimum protection from the virus, adding to fears of public health officials that supplies will be short.
But Novartis' first pilot trial of its investigational A (H1N1) with 100 subjects indicates strong immune response in 80% of subjects after just one dose, and more than 90% after two doses.
Dr Andrin Oswald, chief executive of Novartis vaccines and diagnostics, said the results for the vaccine, to be called Celtura, are encouraging.
He added: "The study suggests that while two doses seem to provide better protection, one dose of our adjuvanted Celtura vaccine may be sufficient to protect adults against the swine flu. This is important information for public health authorities who prepare for vaccination in the coming months with limited vaccine supply."
The trial was run by the University of Leicester and University Hospitals of Leicester in the UK, testing 100 healthy volunteers aged between 18 and 50.
It evaluated the tolerability and immunogenicity of the vaccine, and different schedules and timing between vaccinations were tested.
Additional pivotal clinical trials, with larger numbers of subjects and sponsored by Novartis, are already under way around the world, and they will include more than 6000 adults and children.
The aim of the trial was to find out how many doses and what type of vaccine is needed to give protection, and the initial results should help to plan vaccination campaigns in the autumn, including doses and timings.
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