Vaccines Europe response to the EMA Regulatory Science Strategy to 2025

Overall views about the strategy proposed by EMA’s Regulatory Science to 2025

EMA’s Regulatory science strategy to 2025 is highly welcomed by Vaccines Europe, a trade association representing the major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe. It is generally accepted that vaccines designed to prevent infectious diseases are one of the most cost effective health care interventions. The World Health Organization estimates that existing vaccines prevent approximately 2–3 million deaths per year. Vaccines have also indirect economic and social benefits such as improved labour productivity and cognitive development, as well as averted treatment costs.

Today, close to 30 diseases are preventable by vaccination but there remain many unmet needs, for example:

  • infectious diseases that have an important medical impact and for which safe and effective vaccines remain elusive (e.g. cytomegalovirus, Chlamydia trachomatis, Clostridium difficile, Staphylococcus aureus);
  • infectious diseases for which vaccines are already available but for which the efficacy should be further improved (e.g. seasonal influenza, tuberculosis, herpes zoster);
  • specific populations that could be better protected (e.g. elderly, immunocompromised patients, travellers).

By preventing infections and so reducing the need to use antibiotics, prophylactic bacterial and viral vaccines are reducing our dependence on antimicrobials. A paper published recently by the independent Review on Antimicrobial Resistance highlights that many vaccines that would play a crucial role in tackling drug resistance are not on the market or even in early stages of development and concludes that there is a need for a much more robust pipeline of new vaccines to help contain rising antimicrobial resistance.

In addition, and in view of the ageing of the population, new vaccines, for instance with adjuvants that specifically target the aged immune system, could help to overcome the limitations of immune senescence and ensure a better protection of the vulnerable elderly population.

The vast majority of the vaccines that are now on the market have been developed through rather straightforward and traditional research models. The complexity of many of the remaining targets necessitates substantial investment of capital and human expertise, making the development of the next generation of innovative vaccines much more complex, challenging, costly and risky for vaccine developers.

Application of novel science and technologies is leading to innovation in manufacturing and to innovative products that are often complex. To foster these innovations, EMA needs to work with other stakeholders including policy makers, academia and industry to facilitate the development of and access to innovative vaccines.

Today there are ongoing EU initiatives related to vaccines and vaccination, such as the EU Joint Action on Vaccination (EU-JAV). In parallel, vaccine manufacturers are operating on a global scale and a large part of vaccines produced in EU are exported to third countries. It would be useful to identify areas where EMA needs to collaborate with additional stakeholders (National competent authorities, HMA, ECDC, WHO, national vaccine policy makers, non-EU regulatory agencies) as some of the items identified are ambitious topics where European and/or internationally harmonized approaches would be important (eg. Real World Data).

Find the full Vaccines Europe response submitted to EMA on this link.