As health threats go, antimicrobial resistance is guaranteed to hit the headlines whenever it raises its head, as shown recently when England’s chief medical officer, Professor Dame Sally Davis, said the problem could spell the “end of modern medicine.”
But another, less headline-grabbing threat is emerging in Europe: a decline in vaccination rates that has led to outbreaks of vaccine-preventable diseases (VPDs) that were thought to be under control, such as measles. Such declines are not easy to detect, which presents challenges for drug companies when planning their vaccine production schedules to deal with potential outbreaks.
Nevertheless, efforts are underway to tackle the problem to address the needs of both public health and pharmaceutical companies, which need to ensure that their vaccine production is aligned with actual needs and require a predictable way of understanding how to do so.
Between January 2016 and October 2017, almost 19,000 cases of measles were reported in the EU, including 44 deaths, and there is a risk of spread and sustained transmission in areas with susceptible populations, according to the European Centre for Disease Prevention and Control (ECDC). The highest numbers of cases were reported in Romania (7,570), Italy (4,617) and Germany (891).
Of all cases reported between September and August 2017, 87% had not been vaccinated, and measles is increasingly affecting all age groups, with 47% of cases in 2017 seen in those aged over 20, compared with 25.5% in 2016.
The slowdown in vaccination rates was discussed at two sessions of the recent European Health Forum Gastein conference in Austria, including the reasons for the decline and the need for better policies in Europe to achieve optimum protection of the population against VPDs.
Following the sessions, Patricia Massetti, Associate Vice President, European Vaccines Lead at MSD, told the Pink Sheet that it was difficult to get an overall picture of vaccination rates in the various EU member states because countries vary in how they record their health information.
“In some countries you may have pockets of information in hospitals or with GPs [general practitioners] depending on whether the vaccine is given by the GP, the immunization center or a hospital. So there might be very good data, but they don’t necessarily communicate amongst each other, and when you try to pull it all together it doesn’t necessarily make sense,” she said in an interview.
This makes it difficult to detect the decrease in vaccination rates over time, and “all of a sudden you don’t have the herd immunity anymore, so the disease crops up again, and when this happens it puts strains on the system.”
“If you don’t see it coming there is this very rapid increase in demand for doses and it puts huge pressures on production systems” – Patricia Massetti, MSD.
This, Massetti said, made it difficult for governments and companies to forecast possible outbreaks and plan vaccine production schedules to deal with them. “The pressure is on manufacturers because if you don’t see it coming there is this very rapid increase in demand for doses and it puts huge pressures on production systems – as you know vaccines take years to produce.”
“It is really important to understand what is happening with vaccination across Europe so we can be in a better position to be always proactive in terms of vaccination and making sure it gets to the population that needs to be protected,” Massetti added.
Why The Hesitancy?
There are thought to be a number of reasons behind the phenomenon of “vaccine hesitancy.” The term is defined by the World Health Organization as meaning a delay in acceptance or the refusal of vaccines despite the availability of vaccination services, because of factors such as complacency, confidence and access.
“Some people are complacent, they don’t think the disease is serious enough, or they don’t have confidence in the vaccine,” according to Andrea Ammon, who was appointed the new director of the ECDC in June this year. “Others can’t get access to the vaccine,” and in some countries anti-vaccination campaigners are still influential, Ammon, who moderated an EHFG workshop on the topic, told the Pink Sheet in an interview. Attitudes to vaccines don’t just vary from country to country, she said, but within countries and depending on the type of vaccine.
One challenge is that anti-vaccination groups are still active, particularly in social media, and are undermining public trust in vaccination – something that Ammon said was important in the context of the “post-factual era.” In Italy and Germany, she said, “anti-vaccine attitudes are really the reasons for the measles outbreaks,” while in Romania “a large part of the problem is that there are remote populations that cannot be reached.”
It’s also an unfortunate fact that many, especially younger, people have no experience of the effects of some of the major diseases that have been all but eradicated by vaccination, and so may not see the need to vaccinate to achieve herd immunity.
The disappearance of many diseases, like polio and smallpox, from Europe means that people don’t appreciate the detrimental effects of having no vaccination, according to Massetti. “They ask: do I really need to be vaccinated anyway, because the disease doesn’t exist any more?”
Tackling The Decline
As to what can be done about the fall in vaccination rates, Ammon said it was a “multifaceted problem” but there were some practical steps that could be taken. France, for example, has decided to expand the number of mandatory vaccinations from three to 11 as of January 2018.
In Denmark, which saw a “huge” drop in HPV vaccination after alleged side-effects emerged, “they have now launched an information campaign for doctors and parents, which is quite promising.”
But Ammon cautioned that information packs help only to a certain degree. They “don’t address the emotional part of this reaction,” she explained, and some countries are adapting their own approaches so that the “scenarios presented fit into people’s actual situations.”
She suggested that it was important to train young people in the “critical appraisal of science”, and “as many of these concerns are spread through social media, you need to put counter information into social media. I think the younger doctors are used to this but many doctors and nurses and public health authorities have not been regulatory engaging with social media, so this is where we need to move out of our comfort zone.”
A technical advisory group of country representatives met at the ECDC a couple of weeks ago to discuss vaccination communication challenges for the first time, Ammon noted.
Also under discussion at the moment is the idea of establishing proper vaccination registries at national and possibly EU level. Delegates at the conference in Austria discussed how this might be done, including the technical challenges of gathering and assessing data produced via different platforms by different countries.
“National vaccination registries would be beneficial for patients and allow health authorities to assess coverage rates” – Andrea Ammon, ECDC director.
Ammon said the ECDC was not involved at the EU level but it is looking at how it can help countries to establish national vaccination registries. “It would be really beneficial for the patients who could at any time link into this and see what their vaccination status is,” and would also allow health authorities to assess coverage rates, she said.
The EU Joint Action
The pan-EU registry idea is one component of a wider “Joint Action for Vaccination” that the European Commission launched this year and which includes a work package on vaccine hesitancy. A roadmap has been produced for each country to pursue the various objectives of the joint action, which involves more than 20 countries.
Massetti said that industry is involved in the joint action on vaccination through the various vaccines companies, including hers, that are part of Vaccines Europe, a specialized group within the European Federation of Pharmaceutical Industries and Associations. Companies were invited to give feedback on the joint action, which they did in the form of a white paper that “really represents the view of the industry and how it can support the key main streams announced by the Joint Action Committee.”
The white paper, issued in May this year, says the joint action needs to address a number of key areas. These include:
- Strengthening European surveillance capabilities to better assess infectious disease patterns, vaccines benefit/risks and the impact of vaccination across all ages.
- Establishing systems to better predict the evolution of vaccine recommendations and more accurately forecast demand for vaccines, through early and continuous dialogue between companies and health authorities.
- Defining vaccine research priorities and to implement policies that reward innovation and ensure vaccines are appropriately valued – this includes ways to overcome barriers to the discovery and development of the next generation of vaccines capable of addressing unmet medical needs.
As for the benefits of the vaccination joint action for industry, Massetti said: “We will be much better prepared as regards having the right capacity in place to fulfil needs of Europe or any part of the world that is part of this kind of action.”
She said it was critical for companies to be able to ensure that what they produce is aligned with the actual needs. “You need a very predictable way of knowing how to produce your vaccines. For example, if you need to scale up your capacity, building a vaccines plant takes three or four years, and we are talking about several hundreds of millions of investment, and you need to know in advance how you will handle these kinds of investments.”
There was also a knock-on effect for future R&D investment decisions, she said. “The data is not only about current diseases, but how diseases in general evolve in the population, and it can give good input on where to focus our research programs in terms of innovation for the future.”
“The problem is that if we don’t have a clear view of the needs moving forward it is very difficult to adjust the capacity and even more difficult to be able to produce in time so we can fulfil the needs.” Reflecting on the recent measles outbreak, she said it had been “difficult to find enough doses because we didn’t see it coming.”
The joint action seems to be heading in the right direction, though, at least as far as Massetti is concerned. She said it would “really help to ensure the framework is there, and also that there will be concrete actions. I think we are at a stage where we move from principles and high-level philosophy to more practical implementation.”
She said there was a lot of commitment to the joint action from politicians, healthcare professionals, industry, and patient associations. “People see the value. Coalitions – this is where things have the best probability of happening.”
As to how the joint action will progress from here, Massetti said there have been some consultation meetings, and “now we have to see what the plans will be. We are not only like the vendor of the vaccines, we also need, for example, to make forecasts for vaccine needs. We are always available to provide feedback. We really believe industry is part of the solution.”