On March 9, the FDA Commissioner, Scott Gottlieb, testified before a Congressional committee regarding the 2017–2018 influenza season. Gottlieb’s testimony highlighted ongoing collaboration between the US government and biopharmaceutical industry for the development of more efficacious influenza vaccines.
These public-private partnerships (PPPs) are focused on advancing the biomedical science of influenza vaccine R&D and upgrading vaccine manufacturing infrastructure, with the ultimate goal of developing a universal influenza vaccine.
The 2017–2018 influenza season has been the worst to hit the northern hemisphere in recent memory. In February, the FDA estimated vaccine efficacy of 36% for the season. Notably, preliminary data from the FDA and US Centers for Disease Control and Prevention (CDC) indicate that non-egg-based vaccines have been more effective in preventing influenza during the 2017–2018 season compared with the traditional egg-based vaccines.
While GlobalData believes that a shift away from egg-based vaccines could occur within the next few years, the availability of a universal influenza vaccine, Commissioner Gottlieb summarized, is “still many years off.” GlobalData anticipates that government support to the biopharmaceutical industry will continue regarding next-generation influenza vaccine development, helping to facilitate the transition to cell and recombinant vaccines.
Collaborations for influenza vaccine development
There are several examples of PPPs for alternative influenza vaccine development. For the US government, its eye is on investing for production of products that will prevent a virulent flu pandemic. In September 2017, the Biomedical Advanced Research Development Authority (BARDA) of the US Department of Health and Human Services (HHS) published a press release announcing its collaboration with Johnson & Johnson (J&J) on development of a potential universal influenza vaccine and further development of a small molecule anti-influenza drug.
In 2018, the National Institutes of Health (NIH) announced that it will begin enrolling volunteers for Phase II clinical trials of an H7N9 influenza vaccine. Transmission of H7N9 between people is low. While mostly zoonotic, a viral mutation of H7N9 can create an influenza pandemic amongst humans. This H7N9 vaccine candidate was developed by Sanofi Pasteur with support from BARDA. A vaccine adjuvant developed by GlaxoSmithKline, with support from BARDA, will be included in the clinical trial.
These and other influenza vaccines, including universal-stage versions, are in development from a variety of small and large vaccine developers. Cell and recombinant vaccine technologies are beginning to prove their improved effectiveness against influenza when compared to egg-based vaccines. They are better accommodation for creating vaccines that match changes in the influenza virus that result from viral evolution drift.
The vaccine manufacturing process must be modernized to allow for novel vaccine technologies to meet their full potential. Commissioner Gottlieb addressed this concern in his prepared remarks to Congress by mentioning the FDA’s investment in continuous manufacturing for vaccines, which could allow for closer to year-round manufacturing of vaccines despite input of new vaccine strains in the manufacturing line.
In contrast to their egg-based counterparts, cell and recombinant-based vaccines are amenable to continuous manufacturing production times. Because PPPs are helping to advance vaccine manufacturing technology, they are essential to the development of more effective influenza vaccines.