As manufacturers and researchers toil on alternatives to the tried-and-true but time-consuming technique of egg-based production for the seasonal flu vaccine, University of Pittsburgh researchers are wrestling another impediment: defining "go time." They've developed a model intended to balance strain-composition decision-making against timing, EmaxHealth reports.
Annual flu vaccine virus strains are normally determined half a year before flu season to allow time for strain growth and vaccine production. Decisions made that far in advance aren't always optimum. An incorrect decision will lead to a less effective vaccine, while a later but better-informed decision will likely lead to supply shortages, the report said.
Most seasonal and pandemic vaccine production improvement efforts have focused on cell culture techniques to sidestep the onerous step of growing viruses in chicken eggs. One recent example is the nearly $1 billion North Carolina facility declared ready last month by Novartis ($NVS) and the U.S. Department of Health and Human Services, which will use such production techniques for pandemic and bioterror preparedness.
Egg elimination is also the objective of the GlaxoSmithKline ($GSK) alliance with Alnylam Pharmaceuticals ($ALNY) announced in November; the alliance is intended to join the latter's RNA interference technology with GSK vaccine production savvy. Another example is the government-funded Texas Plant-Expressed Vaccine Consortium's Project GreenVax, which aims to use tobacco as a much quicker growth medium than eggs.
By contrast, the University of Pittsburgh researchers' model allows healthcare officials to consider the effects of multiple changes on vaccine design and production, according to the EmaxHealth report. One variable is the number of strains to include in a seasonal flu vaccine; another concerns the frequency of FDA sampling of flu strains around the world. In addition, the researchers suggest that more collaboration among the U.S.' flu shot manufacturers and the FDA after the agency has determined vaccine composition could help improve manufacturing techniques, the report said.
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