Giovanni Rezza: Mandatory vaccinations in Italy—scientific evidence and political controversies

Vaccine mandates have become increasingly politicised in Italy, but policy must be guided by evidence

Vaccines are the victims of their own success. Thanks to them, vaccine preventable diseases have declined or even disappeared, but this can lead to the perception that these infections are of a low risk, causing complacency, which is a factor in vaccine hesitancy and refusal. With the World Health Organization (WHO) announcing this week that the number of measles cases in Europe has reached a record high this year, it’s a reminder that we cannot be indifferent to rising anti-vaccine sentiments.

In Italy, which is one of seven European countries to have seen over 1000 cases of measles so far this year, expressions of vaccine hesitancy are no longer confined just to certain geographic pockets or groups. Vaccines have become a national talking point and were a divisive issue for voters in the March elections.

One of the principal sources of division has been Italy’s laws on compulsory vaccinations. In countries where vaccine recommendation policies have not been successful, immunization mandates are often the next step to maintaining high levels of vaccine coverage. In particular, mandatory vaccination for childcare or school entry (with/-out penalties) is a consolidated strategy—in the US it has been implemented and tested for decades.

Yet vaccine mandates are also a source of long standing controversy due to unresolved conflicts between those who object to mandates by invoking the principle of individual freedom, and those who prioritise community protection. Evaluating the impact of mandates on vaccine coverage and its possible drawbacks is therefore a topic of critical importance, and is particularly relevant for Italy, where a vaccine mandatory law approved last year looks increasingly likely to be revised.

Evidence of the positive effect of vaccine mandates and law enforcement come mostly from the US. A paradigmatic example is represented by the rapid increase of vaccination coverage recently observed in California after they tightened up immunization requirements for school entry.

On the other hand, a study comparing different European countries suggested that mandatory vaccination is not a determinant of the level of vaccination coverage. It’s worth noting, however, that simple comparisons of vaccination coverage between different countries are affected by confounding factors, such as the level of health literacy among the population or the efficiency of a country’s vaccination system.

In Italy, we’ve had mandates for four vaccines (polio, diphtheria, tetanus, and hepatitis B) that for many years were in name only (sanctions were never applied after 1999). But in the face of drops in vaccination coverage between 2013 and 2015, with uptake of the MMR vaccine falling as low as 85%, the question of mandates became more pressing.

The Italian government decided to reinforce vaccine legislation in 2017 with a new law making 10 vaccines mandatory for access to nursery (denied attendance for children ≤6 years of age) and primary and secondary schools (fines for unvaccinated students). The measure was also justified by the occurrence of a large outbreak of measles in 2017, which saw more than 5000 cases and four deaths, and by the need to protect immunodepressed individuals.  

The new Italian law showed immediately promising results, leading to a 1.2% and 4.4% increase in vaccination coverage for the hexavalent and MMR vaccines, respectively. It’s been reported that this trend has apparently persisted in 2018 (unpublished data).

However, polarised political and social debate, and noisy opposition to the law led by the “free-vax” movement, made the vaccine mandate a political issue during the pre-election campaign for the March 2018 vote. Political parties involved in the former government strongly defended the new law and its enforcement, whereas the so called “populist” parties, which represented a large part of the opposition, claimed that they were in favour of vaccines but against coercive measures.

The government agreement signed by the two parties that won the elections now opens the door to revisions of the vaccine mandatory law, and already the Senate has voted through an amendment to suspend for one year the legal requirement that parents vaccinate their children before sending them to nursery. The amendment still needs to be approved by the lower house and cannot come into force before the new school year. However, more permanent legislation on freedom of choice could be introduced in the near future.

Strong opposition to compulsory vaccination for ideological reasons is common not just in Italy, but throughout Europe. Maintaining high vaccine coverage without mandates would always be the ideal, but the Italian context makes this difficult at the moment due to low health literacy, a high proportion of vaccine hesitant parents (a survey conducted in 2016 on more than 3000 parents found that 0.7% of them were anti-vax and 16% were hesitant), and strong media pressure by the anti-vax movement.

Furthermore, as I’ve already pointed out, there is evidence that Italy’s mandate was already starting to improve vaccination rates. For these reasons, it would be wise to keep the mandate until herd immunity for measles and high coverage for the other vaccines are ensured.

However, it’s important that decisions to adopt a non-coercive approach are accompanied by plans for a cost-benefit evaluation. The success of different vaccination strategies depends on the geographical and cultural context of where they’re used, and such evaluations should be country specific.

It’s not unreasonable for the Italian government to consider the possibility of revising, to some extent, vaccine mandates, but any changes should be guided by scientific evidence; supported by adequate investments; and cautiously evaluated, rather than being rushed through with urgency. When so much is at stake, we can’t afford to be driven by the tide of political opinion under the pressure of ideologized minorities.

Giovanni Rezza is the director of the Department of Infectious Diseases at the Istituto Superiore di Sanità (National Institute of Health, ISS) in Rome, Italy. His main background is in infectious disease epidemiology and vaccination strategies. He has served as an expert for national (Ministry of Health) and international (EU, WHO) organisations, and is currently a member of the Italian national immunization technical advisory group.

Competing interests: I have read and understood BMJ policy on declaration of interests and declare that I have no conflicts of interest concerning this article.