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.

Caregiving has traditionally been a female area, both domestically and in the workplace. Due to the nature of influenza, healthcare workers and those in close contact with young children are at a greater risk of exposure to influenza viruses, both seasonal outbreaks and pandemic strains (Zhang et al 2011). Studies have generally shown compliance rates from as low as 10% to 40-50% among healthcare workers, with no clear pattern to ascertain why this is (Tell Me 2012).

Women who are pregnant are more likely to have severe disease and hospitalisation with either seasonal or pandemic influenza, compared to the general population or compared to non-pregnant women of the same age group. During pandemics, the mortality rate for pregnant women is higher than non-pregnant women. However, this is not the case with seasonal influenza unless the strain is particularly severe (WHO 2010).

Persons over the age of 65 have a higher risk for severe influenza-related complications and have the highest risk of mortality from influenza. Vaccination of older persons have traditionally been the main focus of influenza vaccine policy, and while vaccines are not as efficient in this population as in younger adults, it still remains the most effective public health tool to protect against influenza (WHO 2012). Vaccination recommendations vary slightly between countries in Europe, however almost all cover older people as a specific target group (Endrich et al 2009).

People with already existing conditions, such as cardiovascular diseases, diabetes, and pulmonary/respiratory disease, are at greater risk from influenza (Logue et al., 2011). Women are more likely to have diabetes in their lifetime than men, and studies in the US show that women, particularly those in lower socioeconomic groups, receive less adequate diabetes care than men from the same socioeconomic group (WHO, 2010).

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.

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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
Engaging all of Europe in shaping a desirable and sustainable future
Expect the unexpected and know how to respond
Driving innovation in crisis management for European resilience
Effective communication in outbreak management: development of an evidence-based tool for Europe
Solutions to improve CBRNe resilience
Network for Communicable Disease Control in Southern Europe and Mediterranean Countries
Developing the framework for an epidemic forecast infrastructure
Strengthening of the national surveillance system for communicable diseases
Surveillance of vaccine preventable hepatitis
European monitoring of excess mortality for public health action
European network for highly infectious disease
Dedicated surveillance network for surveillance and control of vaccine preventable diseases in the EU
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
Addressing chronic diseases and healthy ageing across the life cycle
Medical ecosystem – personalized event-based surveillance
Studying the many and varied economic, social, legal and ethical aspects of the recent developments on the Internet, and their consequences for the individual and society at large
Get involved in the responsible marine research and innovation
Knowledge-based policy-making on issues involving science, technology and innovation, mainly based upon the practices in Parliamentary Technology Assessment
Assessment of the current pandemic preparedness and response tools, systems and practice at national, EU and global level in priority areas
Analysis of innovative public engagement tools and instruments for dynamic governance in the field of Science in Society
Public Engagement with Research And Research Engagement with Society
Computing Veracity – the Fourth Challenge of Big Data
Providing infrastructure, co-ordination and integration of existing clinical research networks on epidemics and pandemics
Promote vaccinations among migrant population in Europe
Creating mechanisms for effectively tackling the scientific and technology related challenges faced by society
Improve the quality of indoor air, keeping it free from radon
Improving respect of ethics principles and laws in research and innovation, in line with the evolution of technologies and societal concerns
Investigating how cities in the West securitise against global pandemics
Creating a structured dialogue and mutual learning with citizens and urban actors by setting up National Networks in 10 countries across Europe
Identifying how children can be change agents in the Science and Society relationship
Establishing an open dialogue between stakeholders concerning synthetic biology’s potential benefits and risks
Transparent communication in Epidemics: Learning Lessons from experience, delivering effective Messages, providing Evidence