FDA Commissioner Scott Gottlieb, MD, testified on the agency's response to the 2017-18 flu season during a March 8 hearing with the U.S. House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations.
Here are four quotes from Dr. Gottlieb's testimony.
On a universal flu vaccine: "[I]nvesting 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. While we should continue to focus on the discovery of a new breakthrough vaccine, we also must consider what immediate and intermediate steps we can take to enhance the production of existing licensed vaccines."
On egg-based vaccines versus cell-based vaccines: "Some studies have found that cell-based and recombinant vaccines are more efficacious, or could be more efficacious, than egg-based vaccines; but, more data and analyses are needed. As one step to better understand the differences between egg-based and cell-based technologies, we're using CMS data to compare Medicare patients that received a cell-based vaccine to those who received an egg-based vaccine to determine which vaccine was more effective in that population."
On improving vaccine manufacturing: "The FDA is working to help develop more effective cell lines that can be better scaled through continuous manufacturing. We're also looking at how we develop a more robust recombinant vaccine manufacturing process to increase yield, while reducing cost. Continuous manufacturing holds great promise for both cell-based and recombinant vaccines, because supply could be more easily ramped up on short notice. This would allow us to more rapidly address newly emerging strains or strain drift."
On this year's vaccine efficacy: "As we prepare for next year's flu season and analyze the data from this year, we're trying to better understand why this year's vaccines were less effective against the H3N2 strain … we're looking at several factors to better understand why effectiveness tends to be lower against this strain."