In January, Protein Science’s FluBlok® became the world’s first recombinant influenza vaccine, developed using insect cell culture. Currently approved for people between 18 and 49 years old, approval for all persons 18 and older is expected later this year. Limited supplies are available now, with full availability anticipated for the 2013/2014 flu season.
Novavax has taken another approach, combining insect cell culture and recombinant baculovirus protein nanoparticles, to produce influenza vaccine candidates. The company is targeting seasonal and pandemic flu, as well as respiratory syncytial virus, SARS, malaria, and rabies.
Astellas is in late-stage clinical trials for its recombinant H5N1 influenza vaccine, ASP7373. The vaccine is being produced by cell culture, using the baculovirus expression vector system developed at the University of Minnesota.
In November 2012, Novartis’ Flucelvax® became the first mammalian cell-based flu vaccine approved by the FDA. GSK, Astellas, Sanofi, Baxter International, and AstraZeneca also are developing nontraditional manufacturing methods.
As next-generation vaccines mature, Chidambaram said, “they are likely to provide huge cost-savings and therapeutic benefits, and can significantly reduce vaccine development time.”