The contribution of vaccine manufacturers to the establishment of vaccination policies

Aim This paper seeks to analyse the contribution of vaccine manufacturers to the establishment of immunisation policies. Subjects and methods The recent evolution of the role of industry from product development to post-licensure studies is reviewed in detail. Results The primary responsibility of vaccine manufacturers has always been to develop vaccines and demonstrate their safety and efficacy. However, with the development of new vaccines it appears that vaccine manufacturers are expected to go beyond this role and to provide policy-makers with additional information required to support the establishment of optimal vaccination policies. This includes conducting extensive post-licensure risk management plans as part of follow-up measures to the initial marketing authorisation. Manufacturers are also requested to generate information on the epidemiology of the disease to be prevented as well as health-economics data and to assess the expected impact of the vaccine in the population. This requires additional in-house skills, external collaborations, not to mention considerable financial investment. Conclusion Over the recent decades new functions and departments have been created to address all the technical aspects leading to the introduction and adoption of new vaccines, such as risk management, epidemiology, policy affairs, and outcome research. Nevertheless such activities cannot be properly conducted or managed without an active partnership between the private sector and national or international public heath or academic institutions.