Immunisation politicised

2006 and 2007 saw the first worldwide approvals of vaccines designed to immunise women and girls in particular against certain strains of the sexually transmitted human papilloma virus (HPV), including strains that lead to cervical cancer. Yet the notion of vaccinating children against sexually transmitted and carcinogenic viruses generated debate and at times controversy in North America and Europe alike. Some feared that the vaccine would lead to unsafe sexual practices, and Conservatives even labelled it the 'promiscuity vaccine'. Practitioners were concerned that a hasty introduction of the vaccine would lead to lower participation rates in cervical cancer screening programmes using the pap smear test. Feminists pointed to the gendered nature of the vaccine, raising questions as to why only women appeared to have been considered in vaccine development, much like they have historically been in contraception research and development.

These objections to the HPV vaccine featured in many countries yet the vaccine was introduced rather rapidly in most countries. A research project at the University of Vienna, funded by the Austrian Science Fund (FWF, grant #1477), presents the case of Austria. Despite its small size as a pharmaceutical market, much can be learned from this particular instance of HPV policy, as early results recently published in Social Science & Medicine indicate.

Studying vaccination policy as a social scientist
In our project we identified the main players in vaccination policy and conducted semi-structured, in-depth interviews with stakeholders from medicine, politics, industry, civil society and government agencies to reconstruct the policymaking process in Austria. We then compared the process in Austria to the introduction of the HPV vaccine in the Netherlands, where the vaccine had already been implemented on a national scale in 2008, after initial reservations had seemingly been overcome. A comparative article will be published shortly, drawing on the same methodology and fieldwork in the Netherlands with colleagues at Erasmus University Rotterdam.

Reshaping the HPV vaccine in Austria
While swift in other European countries, implementation took several years in Austria. In the first stage of Austrian HPV policy, roughly spanning from 2006 to 2008, concerns regarding the safety of the vaccine, its uncertain long-term effectiveness and the high profit margin of the vaccine led to its rejection by the then Minister of Health, Andrea Kdolsky, a Conservative politician and medical doctor herself. Trust, credibility and scientific uncertainty surrounding the HPV vaccine played an important role in that phase, and the death of a young girl shortly after her inoculation risked unlocking new fears of vaccination more generally. In anticipation of a potential public controversy, the debate was closed at the level of public policy. While the vaccine remained freely available, it was not reimbursed under the national immunisation programme.

Many countries objected to the HPV vaccine yet the vaccine was introduced rather rapidly in most countries

In the second phase of HPV policy, spanning roughly until mid-2012, the Austrian vaccination policy community - including officials and clinical experts - apparently kept HPV off the political agenda in an attempt to protect the national immunisation programme from further societal critique. In parallel, a large-scale governmental campaign focusing on the MMR vaccine was launched, directing attention to vaccination policy more generally. This phase was used to transform the vaccine into a socially accepted technology, by collecting additional evidence that strengthened arguments in favour of the HPV vaccine. By reducing the administration from three to two shots, while at the same time negotiating a substantially lower price and, crucially, by targeting all nine-year olds as the first country to do so, Austria became a 'European frontrunner' in gender-neutral HPV vaccination.

How did the policy community achieve this turnaround in HPV policy from lagging behind in 2008 to becoming European frontrunner in 2013? First, decision-makers of the Austrian healthcare system, which is organised along federal lines, refined informational materials as well as the underlying infrastructures to achieve public acceptance for the HPV vaccine - for instance, by allowing vaccinations to take place in schools in some of its federal states, and allowing completion within one school year. Second, policymakers succeeded in desexualising the topic by specifying that the vaccine was to be administered to both girls and boys before they reached adolescence, thus transforming it from a gynaecological product to a vaccine for children. Third, incorporating it in the national immunisation programme for children appears to have made it easier to sidestep discussions with parents and to standardise those encounters in informed consent forms. Overall, these strategies of considering and tinkering with both the vaccine and the infrastructure in which it was to be embedded amounted to a social and technical 'transformation' of the HPV vaccine.

Culture and evidence
The decision about implementation or non-implementation of a national immunisation programme is the result of a series of discussions, held partly at an informal level and not always transparent to the public, as our research reveals. A host of factors determine whether progress in medicine, such as the HPV vaccine, is considered a promising innovation or a socially undesirable technology. What constitutes a welcome innovation, rather than a controversial technology, is strongly influenced by societal discourse, of which scientific evidence is just one of many components. Moreover, the very criteria societies use to qualify some evidence as important, but not other forms, are the result of complex historical and political processes - as made abundantly clear by historians of science. For example, the remarkable silence around the fact that some strains of HPV can also cause penile cancer, anal cancer, and cancer of the head and neck similarly points to the selective perception of what evidence counts as relevant and what does not.

More trust in pharma products, their role in healthcare systems and scientific practice [is needed]

Implications for research
New technologies do not remain unchanged and stable when they become inserted into national healthcare systems. Instead, what we observe appears to be a translation of vaccines into nationally specific technologies. Criteria of success or failure outside the laboratory must be taken into account and the notion of 'innovation' is by no means universal.

Second, distrust in vaccination appears to be a placeholder in political discourse for a variety of sentiments. We need stronger research to make sense of these societal trends - which are certainly not new - instead of marginalising and labelling them as an expression of ignorance. The Netherlands offers an interesting mode of dealing with such diversity by offering so-called alternative child welfare centres to parents and caregivers who wish to depart from national vaccination schedules due to particular beliefs.

Unresolved issues
A number of issues remain unresolved and deserve attention from policy officials, industry and patients alike. First, the effective integration of primary prevention and screening is likely to gain importance given rapid technological advancements. In the Austrian case, the lack of compulsory quality assurance for pap smear tests has long been subject to critique, yet the high degree of professional autonomy has historically shaped a practice where professional associations are charged with quality assurance. This stands in stark contrast to the Netherlands, where smear tests are recommended at five-year intervals for all women aged 30 and over.

Second, in both the Netherlands and Austria, distrust in the pharmaceutical industry has emerged as an important theme. Rethinking and redesigning the nature of industry funding for pharmaceutical research and campaigning, as many have called for, is likely to pay off in the long run by inducing more trust in pharmaceutical products, their role in healthcare systems and scientific practice. At the very least, industry players may wish to join this debate and take a more active role in it.