The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.
Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.
Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.
Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.
Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company said it anticipates continuing through phase III and on to market.
As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production, according to a spokesman.