Universal Flu Vaccine Is Still Several Years Away, Fauci Says
Executive Summary
Developing a universal flu vaccine will be iterative process, National Institute of Allergy and Infectious Diseases Anthony Fauci says.
A universal flu vaccine is the best solution to boost the substandard efficacy of the current vaccines for the disease, but it will take several years just for the candidates under clinical development to demonstrate they can induce immunity against a single strain, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci says.
Speaking at the National Press Club last month on the heels of a northern hemisphere flu season with high levels of the illness, Fauci explained that developing a universal vaccine that ultimately targets a broad range of flu strains will be an iterative process, and that the first versions would likely be ready in a few years.
"If you look at kind of the framework of influenza, there are two big groups: group 1 and group 2," Fauci said. "And within each group are these multiple subtypes that we could be infected with. So my prediction … is that the first iteration would be a universal flu vaccine that isn't truly universal, but that covers multiple variations of a single virus, such that H3N2."
Fauci later clarified to the Pink Sheet that he felt it would be "anywhere from three to five years … that one or more of the Phase I and Phase II trials that are already underway with universal influenza vaccine candidates will show that one can induce immunity that covers multiple versions of an influenza virus."
The predicted timeline, Fauci noted, does not account for the additional time it would take for the US FDA to review and approve such a vaccine.
What Would The Vaccine Look Like?
In his remarks, the NIAID director offered some insight as to what a universal flu vaccine would look like.
The strategy is to develop a vaccine "that would induce a response against that part of the virus that doesn't change from season to season," Fauci explained.
While "Universal Flu Vaccine 1.0" might protect against multiple variations of H3N2, Fauci said hypothetically, "Universal Flu Vaccine 2.0" might protect against variations of H3N2 and H1N1.
"So that over a period of years, we would hopefully, ultimately have a vaccine that we can give to children who are six months of age or older, that would essentially immunize them and protect them against any variation of influenza," Fauci said. "And then maybe every several years – I don't think there's going to be one shot forever – but perhaps every several years boost them so that they are ultimately going to be protected."
According to Fauci, young children will likely be the best responders to the universal flu vaccine, since the body "tends to revert back to the first type of influenza you responded to."
But even a universal vaccine will likely have to upgraded over the years, as the virus always has the potential to mutate, the NIAID director added.
In May, the National Institutes of Health (NIH) announced the commencement of a Phase II trial that NIAID is sponsoring, which is evaluating a candidate called M-001 that is under development by Israeli-based drugmaker BiondVax Pharmaceuticals Ltd.
The trial has enrolled 120 healthy volunteers ages 18 to 49, according to clinicaltrials.gov, and will assess the safety of the vaccine by vaccine-related adverse events, along with the the T cell responses to M-001 component peptides after two doses. The trial will last roughly 24 months, including seven months for the individual subjects.
The H3N2 strain was the biggest culprit behind the increased influenza rates in the northern hemisphere this past winter. (Also see "Flu Vaccine Potency Remains Top Of Mind As US Panel Prepares To Pick Next Season's Strains" - Pink Sheet, 27 Feb, 2018.) The egg-based vaccines were less effective in preventing the disease than the cell-based vaccines, which may have been due to production problems with the egg-based product. (Also see "Eggs May Be Culprit In Poor Flu Vaccine Performance This Year" - Pink Sheet, 15 Feb, 2018.)
Although the Vaccines and Related Biological Products Advisory Committee unanimously backed the World Health Organization's (WHO's) strain selections for the upcoming 2018-2018 northern hemisphere flu season, panelists aired their concerns about the limited efficacy of the existing flu vaccines. (Also see "Flu Vaccine Strains Get Easy OK From FDA Panel, But Desire For More Efficacy Remains" - Pink Sheet, 2 Mar, 2018.)