A Shot in the Arm for Common Sense?


Applied Clinical Trials

The conclusions on vaccination that European Union health ministers adopted on December 1 contain several sound thoughts.

The conclusions on vaccination that European Union health ministers adopted on December 1 contain several sound thoughts. Without too much of the equivocation and compromise-ridden ambiguity that often mars EU health council conclusions, ministers said clearly: "An evidence-based, cost-effective, safe, and efficient immunization system is an integral part of a well-functioning health system."

Given some of the recent public resistance to vaccinations in some parts of Europe, the statement is both necessary and helpful. As the ministers remarked, "occasional lack of awareness of the benefits of some vaccines and the increasing refusal of vaccination in some member states may lead to under-vaccination in some populations, resulting in public health problems and costly outbreaks." Vaccination has become something of a victim of its own success, as the conclusions admit: "As a result of the success in reducing the spread of a number of serious communicable diseases due to the widespread use of vaccinations, the population may believe that these diseases no longer represent a threat to public health." Consequently, ministers urged action to inform the population and raise trust in vaccinations programs.

The need is pressing-and indeed more pressing, as the conclusions recognize. Communicable diseases, including some re-emerging ones such as tuberculosis, measles, pertussis, and rubella, still present a public health challenge and can cause high numbers of infections and deaths. There is plenty of new evidence of the need. The recent emergence and outbreaks of communicable diseases such as polio, avian influenza H5N1 and H7N9, Middle East respiratory syndrome caused by a coronavirus (MERS), and Ebola virus disease "have confirmed that vigilance must remain high also with respect to diseases that are not currently present in the territory of the Union," the ministers warned.

So not only is better use of vaccines required, but better vaccines too. Policies are needed "to encourage research, including clinical and post-authorization studies in the field of vaccination" in the EU, to make safer and more effective vaccines available. Ministers instructed the European Commission to ensure that EU funding "is channeled to foster current and future vaccine research, including wide partnership between academia, industry, and public and private funders, and to address and resolve bottlenecks in vaccine development." And member states should be exchanging information in respect of the monitoring of vaccination impact on disease burden and the development of new vaccines.

But just as there is no such thing as a free lunch, there is no such thing as a free vaccine. The ministers' advice and instructions also recognize the costs, so the next steps should be made "taking into account also the financial constraints." Ministers accordingly noted that immunization programs require sustainable access to long-term funding and quality supply, and they explicitly commented on the influence of policy on availability, with recognition of "the positive effect that a reinforced vaccination policy at national level may have on the development of and research in new vaccines in the EU."

The ministers also took account of the need for safety-and of the impact of public perception. They recommended more studies by the private sector, and went on to observe that, "studies on the impact of vaccination programs, carried out independently from commercial interests are equally important. Both kinds of studies can contribute to increasing public trust in immunization." Member states are, accordingly, encouraged to fund independent studies. And there is also a need, they said, to ensure that funding provided by the European Union, academia, public health institutions and public health bodies "is channeled to support post-marketing studies, including studies on vaccine effectiveness and the impact of immunization programs."

One of the reasons that conclusions from health ministers are often a bit of a fudge is the age-old combat over who is in charge of health policy in Europe. This time around, a neat formula inserted at the beginning of the conclusions helped to ease agreement. As the new European Commissioner for Health and Food Safety Vytenis Andriukaitis likes to point out, even with member states still hanging on to their sovereignty in most health matters, there is a sound legal basis for such moves. The EU treaty says that it should encourage cooperation in the fight against major health scourges by promoting research, prevention, and health information and education. There is also provision for EU action "to ensure that member states regularly exchange good practices and experiences on vaccination programs," and for "coordinating their response to serious cross-border threats to health, including communicable diseases." And that is how some common-sense serum has got into the council conclusions on this occasion.


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