The Centers for Disease Control and Prevention recently reported that flu immunizations have been about 36% effective in the U.S. this year, during a season that's been particularly severe. No wonder experts are calling for alternatives, but the "holy grail"—a flu shot that fights any strain of virus—is still years away.
At a Congressional committee hearing on Thursday, FDA commissioner Scott Gottlieb said "investing in—and working toward—the universal flu vaccine is crucial."
"Unfortunately, given where we are today in the development process, that reality is still many years off," he added.
It's not for lack of trying. Industry players ranging from small biotechs all the way up to Big Pharma are working on new flu vaccine technology, and on Tuesday, Israel's BiondVax reported that it signed on with a contract research organization to conduct a phase 3 study of its universal flu vaccine candidate, M-001. The biotech says it has the world's most advanced universal flu candidate.
But while universal flu vaccine research continues, Gottlieb said the FDA is working to better understand alternatives to traditional egg-based production—which may be part of the efficacy problem—and is looking at ways to make manufacturing more efficient. For instance, Gottlieb said his agency is looking at data from the Centers for Medicare and Medicaid Services to understand differences between cell- and egg-based vaccines.
Traditional egg-based flu vaccines take months to manufacture, forcing health officials to predict flu strains for the immunizations far ahead of the actual flu season. Because of strain mismatch and other factors, overall vaccine efficacy has ranged from 10% to 60% in recent years, according to the CDC. Cell-based vaccines are quicker to manufacture, while a universal shot would ideally protect against all strains over multiple years.
In the wake of the tough 2017-2018 flu season, GlobalData healthcare analyst Gilbert Saint Jean, Ph.D., said in a recent statement that it's time for governments to "modernize their partnerships with vaccine manufacturers." The analytics firm concluded that governments and industry should expedite the switch over to new technologies.
A range of drugmakers are already involved. Sanofi recently picked up Protein Sciences and its recombinant protein-based flu vaccine Flublok for $650 million, and separately is working on next-gen flu vaccine technology. GlaxoSmithKline has partnered with Valneva to work on a cell-based option and Johnson & Johnson is collaborating with the U.S. government on a universal vaccine, among other projects. Many other biopharmas large and small are involved through their own work.
Meanwhile, CSL's Seqirus is the first vaccine player to establish commercial-scale manufacturing of cell-based flu shots. The drugmaker recently announced that it's seeking European approval for its cell-based quadrivalent option, eyeing a rollout there for the 2019-2020 flu season.