One example is OptaFlu, made by Basel-based Novartis, the first product based on a more flexible mammalian cell culture process, which has recently become available in Europe. And in the past two years, according to a report published in February by New York–based consultants Oliver Wyman, potential global manufacturing capacity for pandemic vaccines has increased by 300% (for avian H5N1 strains at least) because of process improvements and dose-sparing strategies adopted by producers. Nevertheless, it will take several more years for innovative vaccines—based on recombinant approaches involving fusion proteins, DNA sequences or virus-like particles (VLPs)—to be available at the scale required to cope with a major pandemic.
As Nature Biotechnology went to press, the Geneva, Switzerland–based World Health Organization (WHO) had not altered its recommendations to the dozen or so large and small vaccine producers that are licensed to make seasonal vaccines based on hemagglutinin (HA) and neuraminidase (NA) viral antigens. “Unless we receive the order to produce H1N1 vaccine as a priority we will not be producing it,” says Albert Garcia, spokesman for Sanofi Pasteur, the vaccines arm of Paris-based Sanofi Aventis, which produced about 170 million of the world's total supply of around 400 million seasonal flu vaccines last year. In May, the company received an FDA license for a second production facility at its Swiftwater, Pennsylvania, location, which will add another 100 million doses when fully up and running.
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