Tobacco leaves--Courtesy of David Fisher CC BY 2.0
Following Mitsubishi Tanabe's announcement that its tobacco-based flu vaccine could hit the market by 2018 or 2019, a GlobalData analyst predicted that, if approved, the vaccine could surpass not just currently available egg-based jabs, but also quicker-to-produce cell-based jabs in development.
Egg-based vaccines are typically formulated far ahead of flu season because they take 6 months to produce. This leaves traditional jabs vulnerable to strain drift, which occurs when the predicted strains in the vaccine do not match the strains that actually circulate. A crowd of companies is working on universal flu vaccines that would eliminate the need for a new vaccine each year, but there's still a need for a bridge between currently used egg-based jabs and a universal vaccine.
Mitsubishi Tanabe isn't the only player seeking to develop a faster way to produce flu vaccines. Its competitors include New Jersey's VaxInnate and Maryland-based Novavax ($NVAX), which are both working on recombinant jabs. The former grows flu virus in bacteria, while the latter grows it in insect cells. And while Novavax's flu candidate is further ahead than Mitsubishi Tanabe's in development, growing flu virus in tobacco leaves is cheaper and faster than doing so in insects, making the latter a more promising alternative for traditional flu vaccines, said Achilleas Livieratos, GlobalData's analyst for infectious diseases, in a note.
But it's not quite a done deal. "Mitsubishi Tanabe will need to demonstrate strong safety data and yearly production consistency of its tobacco-based vaccine," Livieratos said. If approved, the vaccine would have a "significant impact on the seasonal influenza vaccine landscape," he said.
Mitsubishi Tanabe plans to first enter the U.S. market and will consider Asian markets if it meets profitability goals, according to Masayuki Mitsuka, the company's president. Japanese regulations prohibiting the commercialization of a vaccine that uses genetic manipulation currently prevent it from moving forward in its home country.