Mandeep Kaur
Project Assistant, European Vaccine Initiative
Ole Olesen
Executive Director, European Vaccine Initiative
Romina Di Marzo
Communications and Advocacy Manager, European Vaccine Initiative
Malaria, a deadly disease caused by Plasmodium parasites and transmitted by mosquitoes, remains a persistent public health concern. To minimize its threat to pregnant women, malaria clinical trials must also consider them.
The World Health Organization (WHO) estimates that 247 million clinical cases and 619,000 malaria deaths occurred globally in 2021, with the great majority of these in Africa.
Consequences of malaria in pregnancy
Pregnant women in low and middle-income countries (LMICs) where malaria is endemic are particularly vulnerable to its adverse effects. Malaria during pregnancy can lead to complications such as maternal anemia, preterm birth, low birth weight, and even maternal and neonatal mortality. These dire consequences underscore the critical importance of effective preventive measures, including vaccines.
Historically, pregnant women have
been excluded from clinical trials.
Clinical trials involving pregnant women
Creating a malaria vaccine tailored for pregnant women offers great potential in reducing the impact of malaria during pregnancy. Such a vaccine could enhance maternal immunity against Plasmodium parasites, lowering infection risks for pregnant women and providing protection for their fetuses, thereby improving maternal and neonatal outcomes.
Historically, pregnant women have been excluded from clinical trials due to concerns about potential harm — resulting in limited data on vaccine efficacy for this group. To address this, concerted efforts are needed to involve pregnant women in clinical trials and consider their distinct requirements in vaccine development.
Developing malaria vaccines for maternal health
The European Vaccine Initiative (EVI) is currently coordinating several efforts to develop a vaccine for malaria in pregnancy. This includes the testing of advanced malaria vaccine candidates in women of childbearing age. Moreover, two placental malaria (PM) vaccine candidates are also being prepared for clinical trials in Europe and Africa.
Advancing malaria vaccine development aligns with global health goals, improving maternal and child health and reducing child mortality. Prioritizing vaccine research, development, and distribution is crucial for a healthier future for pregnant women in LMICs.
The European Vaccine Initiative (EVI) is a Product Development Partnership that has supported the development of more than 40 different vaccine candidates from discovery to early/mid-stage clinical development for different diseases/pathogens, including malaria, leishmaniasis, diarrheal diseases, and emerging pathogens.