Immunization rates in Italy are decreasing at a worrying trend: international targets for measles eradication and safety thresholds in childhood vaccination are vanishing. Authorities, doctors and families are concerned that a coverage below 86% for MPR (measles, parotitis and rubella) vaccine can impair herd immunity, putting younger babies, immunocompromised people and not-responders at risk.
Ilaria Capua, as director of the One Health Excellence Centre at the Emerging Pathogens Institute of the University of Florida, USA, is very busy in coordinating interdisciplinary research, facing the epidemic of zika virus disease spreading in South America and the Caribbean and reaching Florida. Scientists are testing new diagnostic tests and working on vaccines, but the risk of serious birth defects in the offspring of infected pregnant women calls also for responsible procreative choices, involving lawmakers, governments and religious leaders as well.
Internationally, the issue of including women in clinical trials of medicines has been addressed in various guidelines issued by the International Conference on Harmonization (ICH), which promotes regulatory standards for clinical trials. While ICH has specific guidelines on the conduct of clinical trials in paediatric and geriatric populations, there are no consolidated guidelines for the investigation of medicinal product in women.
Month by month, the diseases spread across the world, cities fall into panic and some of them are even wiped out by virulent outbreaks, while tenacious experts cooperate to find a cure before it’s too late.
Since the thalidomide tragedy in the late1950s, there has been a reluctance to include women of childbearing age in clinical trials. However, this fear cannot be used as an excuse to not include females in clinical trials, and, with proper care and regulation, increased female participation has been reached. The United States adopted regulation early on to increase the participation of women, while a new regulation in Europe is going to improve this as well. Here follows an overview of the issue in Canada and in the USA. The third part of this series will deal with new regulation in Europe.
“You cannot use old categories to solve new problems”. Piero Bassetti, president of the Giannino Bassetti Foundation, has been one of the pioneers of the idea of Responsible Research and Innovation in Italy. He started talking about these issues many years before they became central in Science-with-and-for-Society policy at a European level. In this interview, he tells us how things have changed ever since.
Human rights are at the very core of EU democracy. With the entry into force of the Lisbon Treaty in 2009, the Charter of Fundamental Rights of the EU became legally binding and the EU acceded to the European Convention on Human Rights.
In the wake of the 2009-2010 H1N1-pandemic, also known as the swine flu, a web of mistrust between the public and health authorities was spun. National pandemic plans were usually based on a single scenario that was more severe than the actual 2009 pandemic, and that was extrapolated from the severity of previous outbreaks like SARS and Avian flu. In effect the 2009 pandemic was nicknamed the false-pandemic or ‘the pandemic there never was’. However, national health authorities had declared a pandemic and bought vaccines for billions.
Some countries are slowly moving toward the implementation of a two-way PH communication strategy. For example, in May 2010, shortly after the H1N1 pandemic, the public health authorities of New Zealand designed a rapid response initiative to have feedback from population on the communication campaign and on their risk perception. The project consisted in a study, which aimed to retrieve evidence-based information which health authorities could use to design tailored health communication campaigns during/after periods of pandemics.
A very recent and innovative example of good practice concerning awareness campaigns is the “Italian Chart for the Promotion of Vaccinations”, a recent call for action whose website is: http://www.teamvaxitalia.it/. Namely, the Chart is the result of the efforts of the “TeamVaxItaly” movement that had been founded in a civil society meeting in Fano (Italy) in October 2015.