No longer an afterthought: Why pandemic preparedness starts with mothers and infants

27 Dec, 2025

The International Day of Epidemic Preparedness is observed annually on the 27th December. It was established by the United Nations in 2020 – in the midst of the COVID-19 pandemic – with the overarching goal of promoting and emphasising the importance of global collaboration in the prevention of and preparedness for epidemics. Since the COVID-19 pandemic, there have been two Public Health Emergencies of International Concern (both for mpox), plus other outbreaks around the world including ongoing arbovirus epidemics, with resurgence of chikungunya virus disease and over 4.5 million dengue cases worldwide in 2025 alone, measles outbreaks in the United States, and seasonal influenza.  

Despite often being at heightened risk for poor outcomes following infection, pregnant people and their infants have frequently been excluded from pandemic preparedness and response research. This was highlighted by the experience during the COVID-19 pandemic, with pregnant people excluded from most COVID-19 vaccine phase III trials, resulting in a knowledge gap on vaccine safety and efficacy in pregnancy by the time vaccines received emergency authorisation. This led to delayed guidance, for example, with the European Medicines Agency and the European Centre for Disease Prevention and Control not endorsing pregnant people as a priority group for vaccination until August 2021, despite the robust evidence demonstrating increased risk of severe outcomes from SARS-CoV-2 infection during pregnancy. Similarly, national recommendations for vaccination in pregnancy were delayed, tentative and inconsistent, contributing to hesitancy and low uptake.  

For any future pubic health threats, policies for vaccination in pregnancy should be formulated as early as possible. This will require inclusion of pregnant people in clinical trials alongside the general population, in sufficient numbers for meaningful results to be obtained. This aligns with ongoing advocacy for a paradigm shift with respect to clinical research and pregnancy. Multiple agencies and networks have promoted the inclusion of pregnant and lactating people in clinical research in order to achieve earlier and faster study of new drugs and vaccines for these groups*. Public consultation on draft international guidelines on inclusion of pregnant and breastfeeding individuals in clinical trials from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently closed. The forthcoming finalised guideline will support a policy shift from exclusion towards principled, evidence-based inclusion where appropriate, to facilitate ethical, safe and effective use of medicinal products in pregnancy.  

Whilst new guidance should help reduce the historical evidence gap for drug and vaccine safety and efficacy in pregnancy and lactation, the clinical trial ecosystem also needs strengthening, with the addition of specific pregnancy-focussed platforms and networks, such as PIPELINE.

The ambition of PIPELINE is to develop a dedicated pregnancy-infant preparedness platform for adaptive trials in order to improve pandemic preparedness for these underserved populations across Europe. In PIPELINE, we are developing a multi-country adaptive clinical trials platform that can support novel diagnostics, vaccines, and therapeutics for infectious diseases in pregnancy and infancy. We are testing the platform with an adaptive platform trial focusing on respiratory syncytial virus (RSV) immunisation in pregnant people and infants. RSV is a common respiratory infection in infants and young children that can result in serious illness and places a large burden on healthcare systems.  

Adaptive platform trials are particularly well suited to emerging pathogen outbreaks, as seen during the COVID-19 pandemic. Their infrastructure (use of a master protocol with ethical approval in place, a ready-to-act trial network and operational governance structures) and design – whereby new treatment / vaccine arms can be added – allow rapid initiation early in an epidemic. The adaptive features mean that ineffective interventions can be stopped early, and allocation of participants can be guided by emerging benefit-risk evidence, which is an ethical advantage as well as increasing efficiency.  

The PIPELINE-RSV trial will not only generate essential evidence to inform clinical practice and public health policy but also supports the development of tools and processes for running adaptive trials in pregnancy that can be pivoted to new epidemic threats. Alongside the trial and its sites, we are building an “ever-warm” network of hospital and community-based sites across Europe (which is integrated within the “Be Ready” initiative) and developing a Virtual Learning Centre to enhance preparedness further and to develop capacity for conducting vaccine and treatment adaptive platform trials in pregnancy and for infants.  

Through these efforts – and with pregnancy and infants as our focus – we are addressing a critical gap in preparedness response and will help to drive accelerated and robust clinical research with these populations in the event of an emerging epidemic.  

Visit www.pipelineproject.eu for more.

*Additional references