
7
Communicable Diseases
Communicable diseases disproportionately affect women, especially in LMICs, due to biological, gender, and pregnancy-related factors. R&D lags: despite high DALYs, only 13% of products target communicable diseases. Urgent, gender-responsive R&D and maternal immunization efforts are needed, particularly as risks continue to rise due to social and environmental factors worldwide.

Communicable diseases, also known as infectious diseases, are diseases caused by bacteria or viruses, transmitted between people either directly or indirectly through contact with animals or vectors.
Biological factors and gender norms can increase women’s exposure risks and lead to disparities in disease outcomes and socio-economic consequences. Limited gender-specific interventions exist to address women’s unique needs; the intersection of pregnancy and infectious disease adds an additional layer of complexity. Sex-related differences in local and systemic immune responses to infections are particularly important in determining differential susceptibility and outcome risks. An opportunity exists to enhance understanding of sex differences in responses to vaccines, preventive measures, and treatments. A comprehensive awareness of the interplay between infectious diseases, sex, and gender will enable the development of suitable, acceptable, and impactful interventions for women’s health.
Women in low- and middle-income countries (LMICs) face heightened vulnerability to infectious diseases due to geographic, socio-economic, and political factors that increase exposure and limit access to prevention and treatment. They experience disproportionately high burdens of HIV and sexually transmitted infections (STIs), along with high rates of malaria and other infectious diseases such as upper respiratory infections, skin infections, and leishmaniasis. The impact of these diseases extends beyond years of disability and lives lost; they can also lead to economic losses from reduced workforce participation and unpaid caregiving, primarily undertaken by women.

The stark contrast between the volume of new products in the R&D pipelines for infectious diseases compared to non-communicable diseases highlights the healthcare inequities faced by LMICs, which bear the burden of most infectious diseases.
While communicable diseases account for 17 percent of disability-adjusted life-years (DALY) globally, this figure surges to 26 percent in low- and lower middle-income countries. Yet only 13 percent of the health products currently in development target communicable diseases. Pregnant women may be more vulnerable to emerging infectious diseases. Maternal immunizations—vital to prevent transmission from mother to fetus— face numerous barriers that impede development, including limited data on safety and efficacy, liability concerns, and limited delivery and monitoring capabilities in health systems.
Despite hard-won advancements in disease control, health systems must prepare to address the growing need for infectious disease prevention and treatment. Climate change and movement of animals to new regions increase the potential spread of infectious diseases. Governments and the private sector must act now to prepare for higher transmission rates and the emergence of novel infectious diseases and build on the past R&D achievements, such as the rapid development of vaccines for COVID-19 and Ebola, pre-exposure prophylaxis for HIV, vector control products for mosquito-borne diseases, and maternal vaccines for COVID-19, tetanus, and pertussis. Stakeholders across the R&D ecosystem should all mobilize to advance R&D for infectious conditions, that affect women differently or disproportionately and that are understudied in women.
Overview Communicable Diseases
Opportunity 7.1 Burden and costs of infections in women: repro tract, during pregnancy
Opportunity 7.2 R&D on microbes and conditions affecting women
Opportunity 7.3 Vaccines for infections affecting women, incl maternal immunization
Opportunity 7.4 Diagnostics for STIs and repro tract infections
Opportunity 7.5 Therapies for infections in women
7.1 Burden and costs of infections in women: repro tract, during pregnancy
Sex and gender influence disease incidence, duration, and severity through differences in vulnerability to infection, exposure to pathogens, and response to illness. For example, an individual’s immune system and pregnancy status both influence their vulnerability and response to illness. Gender influences on social norms or access to resources may also influence exposure to pathogens and illness progression through differences in the ability to access or
utilize treatments.
To effectively identify and address gaps in prevention and treatment measures that meet women’s needs, stakeholders must first understand the burden of infection, disease consequences, and socio-economic costs of key communicable diseases in women. Improving the availability and accuracy of data that captures the sex-specific burden and costs of key communicable diseases in women will enable R&D agenda-setting efforts to prioritize the highest need areas for women.
Progress Assessment
Progress made against Opportunities, from the 2024 Progress Report
Status Substantial Progress
0 % Achievement

Solution Strategies
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Evaluate sex-disaggregated data across infections, including emerging and outbreak pathogens, to determine which affect women disproportionately or differently.
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Map available data and evaluate data gaps for the burden of infection, disease, and costs; link existing datasets for pooled analyses; and ensure sex-disaggregation of data for infectious conditions affecting women disproportionately or differently.
- Utilize machine learning to stimulate data mining to examine large data sets to assess the disease burden in sub-populations of women, especially from disinvested communities.
- Leverage existing surveys and previously collected data (e.g., STI data from HIV prevention studies).
- Develop improved methodologies for estimating the burden of disease, costs, and quality of life impacts of common infections in women at the regional, national, and global levels.
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Strengthen laboratory and surveillance systems to contribute to estimations of the burden of infection and related diseases that affect women disproportionately and/or differently.
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Conduct selected studies on infection and disease prevalence, incidence, and economic and social costs, and studies of infectious etiologies of disease outcomes (e.g., the proportion of infertility that is tubal factor), in strategically chosen locations.
7.2 R&D on microbes and conditions affecting women
Infections not only present direct risks and symptoms but can also impact the development and prognosis of longer-term diseases, such as chronic gynecologic conditions and immune-mediated disorders, which disproportionately affect women. For example, understanding the link between human papillomavirus (HPV) and cervical cancer has revolutionized prevention efforts for this deadly cancer. Studies suggest that infectious agents may contribute to a range of conditions as varied as like irritable bowel syndrome, endometriosis, and Alzheimer’s disease. However, the links between infectious agents and chronic diseases require further investigation. Focusing investments on research to identify the role of microbes as potential underlying causes of chronic conditions can unveil innovative opportunities for prevention and treatment interventions for women.
Progress Assessment
Progress made against Opportunities, from the 2024 Progress Report
Status Moderate Progress
0 % Achievement

Solution Strategies
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Undertake a global audit of research agendas aiming to explore the association between microbes and conditions that primarily and disproportionately affect women.
- Leverage databases to assess associations between microbes and health conditions in women, involving geospatial and modeling experts.
- Assess and develop bio-databases to explore links between conditions.
- Ensure that the local disease environment is considered, e.g., which neglected tropical diseases are endemic in the area that could be causing illness.
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Research the etiology and role of pathogenic infection in the development of autoimmune conditions that disproportionately affect women, such as lupus, multiple sclerosis, and celiac disease.
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Research the potential role of pathogenic infection in the development of other gynecologic conditions, such as endometriosis, abnormal uterine bleeding, polycystic ovary syndrome (PCOS), and fibroids.
7.3 Vaccines for infections affecting women, incl maternal immunization
Women are affected disproportionately or differently by several infectious diseases—such as HIV, STIs, and tuberculosis—that could be prevented through vaccination and other prevention interventions. Pregnancy can enhance the risks of severe presentation of infectious diseases, so prevention is essential to help control adverse outcomes. Pregnancy also presents a unique opportunity to pass disease protection to the growing fetus through maternal immunizations. Clinical trial enrollment has historically excluded pregnant women which has led to limited knowledge of vaccine safety during pregnancy upon initial licensure. However, greater interest in developing maternal immunizations presents an opportunity to accelerate the development of vaccines and prevention interventions that can preserve the health of both women and their infants.
Progress Assessment
Progress made against Opportunities, from the 2024 Progress Report
Status Substantial Progress
0 % Achievement

Solution Strategies
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Evaluate existing data and conduct studies that evaluate differences by sex and gender in acquisition and transmission risk, disease progression, and immune responses to infection.
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Develop and evaluate vaccines and other prevention measures, including those that can be used in pregnancy, that prevent:
- High-burden infectious conditions (e.g., tuberculosis (TB), malaria, HIV);
- New and emerging pathogens with outbreak potential;
- Major causes of neonatal and infant illness and/or death (e.g., group B strep, respiratory syncytial virus (RSV), Klebsiella, Acinetobacter).
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Develop and evaluate vaccines, monoclonal antibodies, and other preventive therapies for HIV and other STIs, such as:
- Prophylactic approaches for HIV, herpes simplex virus (HSV), gonorrhea, chlamydia, and syphilis
- Therapeutic approaches for HSV, HPV, and HIV
- Multipurpose prevention technologies that can dually prevent pregnancy and infections
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Evaluate women’s preferences and perspectives in different communities early in product development to encourage prevention interventions that are suitable, deliverable, and acceptable to women in both LMIC and HIC settings.
7.4 Diagnostics for STIs and repro tract infections
Over one million STIs are acquired every day globally. Most STIs are asymptomatic, but if left untreated, they can lead to a range of adverse female reproductive tract outcomes, including infertility, chronic pelvic pain, ectopic pregnancies, stillbirths, and preterm births. Convenient and affordable rapid STI diagnostic tests are lacking in much of the world, particularly in LMICs, where the use of syndromic management (treating based on symptoms without lab tests) misses most STIs given their asymptomatic nature. However, the STI innovation pipeline is rich and numerous platforms exist to develop improved STI diagnostics. Increased attention is needed to bring these products through licensure, WHO prequalification, and implementation in LMICs.
Progress Assessment
Progress made against Opportunities, from the 2024 Progress Report
Status Moderate Progress
0 % Achievement

Solution Strategies
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Advance, develop, and accelerate the uptake of accurate, feasible, and affordable rapid point-of-care tests (PoCTs) for STIs and other reproductive tract infections (RTIs), including:
- PoCTs for gonococcal and chlamydial infections;
- PoCTs that can distinguish active syphilis from latent or prior infection;
- PoCTs for HPV suitable for screening in low-resource settings;
- PoCTs for identifying gonococcal antimicrobial resistance (AMR);
- Improved tests for other STIs/RTIs, e.g., bacterial vaginosis, trichomoniasis, HSV, genital schistosomiasis.
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Evaluate acceptability, feasibility, effectiveness, and cost-effectiveness of existing PoCTs and near-care tests for STIs in LMICs.
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Develop new diagnostic tools for upper genital tract infections and associated diseases (e.g., biomarkers, radiologic tools).
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Develop self-testing and self-sampling tools and strategies for reproductive tract infections.
7.5 Therapies for infections in women
As noted under Opportunity 7.1, sex and gender influence disease acquisition and progression. As a result, treatments may have a differential impact on men versus women, exacerbated by the fact that the male body historically represented the standard and women were largely underrepresented in clinical trials. Furthermore, drug safety in pregnancy is often obscure, with limited data on factors like the effects of gestational timing of exposure to medication. Increased investment in the development of new or improved therapeutics with sex and gender considerations can ensure that women’s needs are being met.
Progress Assessment
Progress made against Opportunities, from the 2024 Progress Report
Status Moderate Progress
0 % Achievement

Solution Strategies
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Develop new or improved therapies for infectious conditions that may disproportionately affect women, for which current treatment is sub-optimal or presents a difficult therapeutic challenge (e.g., curative treatment for HSV, Hepatitis E, treatment for AMR gonorrhea).
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Given the frequency of urinary tract infections (UTIs), recurrent UTIs, and UTIs with AMR organisms in women, develop new or improved therapies for UTIs, including exploring non-antibiotic approaches and re-evaluating evidence for
existing antibiotics. -
Address unique therapeutic challenges during pregnancy and breastfeeding, including re-evaluating evidence of new and old antibiotics/antivirals. Areas of focus could include:
- Develop oral alternatives to benzathine penicillin for syphilis treatment;
- Develop options for treatment of AMR infections (e.g., pyelonephritis w/ resistant Klebsiella);
- Evaluate therapeutics for high-burden diseases (HIV, TB, malaria, hepatitis) and neglected tropical diseases in pregnant and breastfeeding women;
- Create frameworks to ensure the safe early consideration and inclusion of pregnant and breastfeeding women when studying therapies for existing and emerging pathogens with outbreak potential to ensure equitable access.