As developers introduce new vaccines against a host of diseases, more implementation testing is required to best inform rollout decisions.
That’s the position of four experts from the World Health Organization, who published an article in The Lancet calling for implementation studies to serve as a third facet of vaccine research in addition to safety and efficacy testing.
The process, they say, is needed because up to now, implementation assessments have occurred in high-income countries, but new vaccines against dengue, typhoid, Ebola virus and other infectious diseases should have local implementation pilot tests to determine how most effectively to introduce the vaccines. Additionally, for other vaccines, it is “no longer appropriate to shoehorn every new vaccine into the already crowded routine infant immunisation schedule,” as some can’t be given inside the current schedule, the authors said.
The publication comes as GlaxoSmithKline’s first-of-a-kind malaria vaccine Mosquirix undergoes the pilot projects following its EMA approval last year. According to the authors “this approach will allow data collection to address uncertainties from the efficacy trials, without which responsible, full policy advice cannot be made.” And though the tests come with “substantial upfront costs” they will ultimately pay off due to cost savings, the authors point out.
In the case of Mosquirix, GSK ($GSK) has agreed to donate pilot test doses, the article stated.
In a separate vaccine rollout underway, Sanofi ($SNY) has said it is working with local authorities using an algorithm to determine on a country by country basis how best to introduce its new dengue vaccine Dengvaxia.
- here’s the article
NIH-supported malaria vax posts 'encouraging' PhI results