Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine’s safety, effectiveness or possible side effects ¹.
Who would evaluate product as a vaccine? Who is responsible that the vaccine is to be included in schedules? Business case with a set of European Countries.
France, Germany and the UK have specific stand-alone vaccine committees which deliver recommendations the DoH’s usually follow: technical recommendations in France, technical and economic in the UK and Germany.
In France, the pharma company applies for AMM –will gain time in requesting CTV evaluation simultaneously.Ministry of Health (MoH) asks CTV for technical evaluation of the vaccine.
In Germany, sick funds and states need to buy vaccines on a shared cost bases for patients included in the schedule.
In UK, JCVI evaluates and sends recommendation to District of Health (DoH): includes indication, population and scheme. Since 2009, DoH must follow JCVI recommendation by law if vaccination is shown to be cost effective.
Italy has a national vaccine committee. The recommendations need to be transposed into regional guidelines.
In Spain, DGFPS evaluates both drugs and vaccines, assisted by mission appointed expert committees; recommendations need to be transposed into regional guidelines.
=> Globally, following the national recommendation, add a new vaccine in schedule, allows vaccinating at risk population and to avoid potential hospitalization and outbreaks.
The recommendation does not come with any specific funding attached, but will be funded by public and private payers. Nevertheless, she is associated impact on healthcare system from a quality of care and cost perspective.