Success of vaccination programmes is based on citizens' trust in safety of vaccines
There's a conflict of interest at the heart of post-authorisation vaccine evaluation research, argues Jim McMenamin.
Jim McMenamin | Photo credit: I-Move+
The success of our vaccination preventable disease (VPD) programmes is based on the trust EU citizens place in the safety and effectiveness of vaccines. Concerns about vaccine safety and effectiveness in one vaccine can impact public confidence in other vaccines and threaten public health.
For national public health agencies (NPHA) and EU competent bodies it is important to be seen to be doing the right thing in demonstrating safety and vaccine effectiveness (VE) avoiding real or perceived conflicts of interest under EU regulations and laws.
Independent evaluation and communication of the safety and VE of publicly funded VPD programmes should remain the responsibility of NPHAs, their governments and appropriate EU agencies like the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).
Vaccine manufacturers also need to ensure their products meet EU and national licensing requirements. The Innovative Medicine Initiative (IMI) funding mechanisms with public-private partnership (PPP) are proposed by the European Commission as a financial solution for conducting EU VE studies.
We are concerned that proposed PPPs to evaluate the performance of national VPD programmes in Europe may jeopardise efforts to restore public trust in the vaccines that governments recommend.
This is because the current IMI calls do not guarantee scientific independence of the evaluation of vaccine products which precludes participation by many NPHAs.
Funding under IMI is a combination of private and public - equally shared by Vaccine Europe (mainly in kind for human resources and sometimes vaccines) and the Commission (in cash). Arguably through the IMI mechanism, European taxpayers are helping vaccine producers fulfil their EMA obligations.
Other Commission cash funding for vaccine evaluation research is scarce (ECDC annual budget of around €1.3m and no Horizon 2020 research funding in 2018-20). It is often impossible for many NPHAs to respond to the IMI call to tender even though there are no other funding sources.
If the currently proposed IMI mechanisms are used to fund Influenza and other VE studies there is a risk that the majority of NPHAs currently participating in established EU networks such as I-MOVE/I-MOVE+, SPIDNET and PERTINENT will be unable to participate, limiting the capacity to pool data to demonstrate effectiveness at the EU level.
We suggest that the Commission's high level committee on VPD adopts a statement in favour of a new funding mechanism to allow public and private funding to support NPHAs in evaluating national VPD programmes while maintaining total scientific independence in the studies.
This would imply that industry are not involved in the decisions related to the study, design, conduct, monitoring, auditing, evaluation, analysis and communication of results, even as observers in the scientific and steering committees of the projects.
One model would be to establish a European Vaccine Foundation linked to an EU agency (preferably ECDC), with a 'common pot' of public and private money with a steering committee independent from commercial interests. The steering committee would place calls for tenders to which EU research groups can respond.
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