Sex & Gender & Vaccination

Sex & Gender & Vaccination is a platform that gathers contents and articles from ASSET experts aimed to disseminate and promote gender-sensitive and women-centred research on pandemics. In particular, it aims to disseminate information on flu pandemics related risks, notably for pregnant women and infants, preventive measures, antiviral drugs, vaccines and vaccination, and make information available to women to enable them to make informed and responsible decisions. A collection of resources on this topic can be found at this link.

As a part of the ASSET project, the European Institute of Women’s Health were tasked with liaising with local schools to disseminate the activities of the ASSET project. The schools were to have received funding under the Erasmus Plus programme, which is the programme that combines all the EU’s current schemes for education, training, youth and sport in Europe.

Gender is considered a main issue in Horizon 2020, the largest ever EU Research and Innovation programme, with €80 billion worth of funding available over seven years. The European Commission has identified seven priority areas of societal challenges, with the goal targeting investment in research in these fields. They are:

It is often said that sex and gender differences are perceived as overlooked in research design and in clinical trials, even those on vaccines. In 2010, the World Health Organisation (WHO) published the document Sex, gender and influenza, which states that many reports of influenza vaccination rates as well as the safety, efficacy and effectiveness of vaccines around the world do not disaggregate data by sex.

The second edition of the ASSET best practice award for general practitioners has come to an end, with the assignment of the four grants to health professionals or groups of health professionals working in the primary health sector.

Gender issue in clinical trials in Europe

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.

Drug Approval Regulation in Canada and USA

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.

Attention to sex and gender in biomedical, health and clinical research is an important quality and safety issue. Medicinal products are safer and more effective for everyone when clinical research includes diverse population groups. Historically, women’s health issues have focused on reproductive health, followed by gender issues such as behaviour, socio-economic factors, culture, lifestyles and influence biological development and health.

July 13, 2016

Many clinical trials, even those on vaccines, are currently being made without considering the immunological differences that can exist between men and women. Katie Flanagan, senior lecturer of the Department of Immunology at Monash University, in Melbourne, Australia, explains how, and why this needs to be changed.

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MMLAP and other EU Projects

Health system analysis to support capacity development in response to the threat of pandemic influenza in Asia
Making society an active participant in water adaptation to global change
Public Participation in Developing a Common Framework for Assessment and Management of Sustainable Innovation
Effective communication in outbreak management: development of an evidence-based tool for Europe
Developing the framework for an epidemic forecast infrastructure
European monitoring of excess mortality for public health action
Modelling the spread of pandemic influenza and strategies for its containment and mitigation
Cost-effectiveness assessment of european influenza human pandemic alert and response strategies
Bridging the gap between science, stakeholders and policy makers
Promotion of immunization for health professionals in Europe
Towards inclusive research programming for sustainable food innovations
Medical ecosystem – personalized event-based surveillance
Public Engagement with Research And Research Engagement with Society
Computing Veracity – the Fourth Challenge of Big Data
Transparent communication in Epidemics: Learning Lessons from experience, delivering effective Messages, providing Evidence