Sibilia Quilici - 09 Nov 2022
COVID-19 has demonstrated the profound economic and social value of vaccines – from protecting public health, to ensuring health system resilience, and enabling societies and economies to function normally. Moving forward, immunisation systems must be equipped to face current and future challenges. A key area for policy action concerns the country-specific pathways for assessment and decision-making on vaccines.
Often overlooked in policy debates on vaccination, vaccine assessment and decision-making pathways determine which vaccines are included in National Immunisation Programmes (NIPs) – and therefore whether the citizens of that country will have access to them, as well as how soon they are included. The pathways also connect with many other aspects of the vaccines’ ecosystem. Efforts to enhance their design and functioning can therefore deliver numerous benefits.
Ensuring that National Immunisation Technical Advisory Groups (NITAGs) – expert committees on vaccination – are sufficiently equipped for the assessment of pediatric, adolescent and adult vaccines would, for example, support the transition towards life-course immunisation. Implementing ‘horizon scanning’ (to identify vaccines that may be licensed in the near future) would similarly contribute to long-term planning of immunisation systems and more sustainable financing of NIPs.
Most importantly, there is a need to address cross-country differences in the timeliness of vaccine assessments and decision-making, which affects how quickly citizens are able to access new vaccines. Research by Vaccines Europe shows that, in seven EU Member States, population access to vaccines (i.e. the period between a vaccine receiving marketing authorisation and its inclusion and funding in the NIP) takes as little as two years. In ten Member States, it takes between two and six years, while in a further nine Member States, it takes more than six years.
The result is that the citizens of some European countries may wait significantly longer in order to benefit from new vaccines than their counterparts elsewhere in the European Union. In the spirit of EU solidarity and cooperation, we cannot let such inequality persist.
Four principles to enhance vaccine assessment and decision-making pathways
A new Vaccines Europe policy paper focuses on the actions that are needed, both at national and European level, in order to enhance vaccine assessment and decision-making pathways across the European Union. In particular, it highlights four principles that should inform the design and functioning of these pathways: timeliness, inclusiveness, consistency, and transparency of assessments and decision-making by public authorities.
To improve timeliness, governments should strengthen the resources and capacities of NITAGs, including with respect to adult immunisation, and implement horizon scanning if this is not already taking place. Inclusiveness requires mechanisms for consultation with all relevant vaccines stakeholders.
Greater consistency can be achieved through the adoption, publication, and systematic use of a clear framework (per country) for analysis and decision-making on vaccines. At the EU level, the 2021 EU Regulation on Health Technology Assessment (HTA) can contribute to greater consistency in vaccine assessments, provided the implementation of the Regulation takes into account vaccine specificities.
Transparency can be improved through the publication of the rationales underpinning vaccine assessments and decisions. Ensuring that official information of this kind is accessible to the public can also make an important contribution to improving vaccine confidence.
More broadly, Vaccines Europe calls for sustained stakeholder engagement at EU and national levels – including, health care professionals, public health experts, patient and civil society representatives, and vaccine manufacturers – to ensure that the whole vaccine ecosystem can contribute to building effective and resilient immunisation systems.