Convening of Stakeholders: Vaccine Evaluation in Pregnant and Breast-Feeding Women to Support Product Information Language and Access

In February 2026, regulators, vaccine developers, funders, and policymakers will meet in Nairobi to tackle the persistent reluctance to test vaccines in pregnant and breast-feeding women during clinical trials. This matters because pregnant and lactating individuals are routinely excluded from vaccine trials, even though scientific and ethical arguments now support their inclusion. The result is a critical gap in safety and efficacy data for this population, leaving clinicians and patients without clear guidance. The convening aims to identify concrete strategies—regulatory, procedural, and cultural—that can break this stalemate. If successful, the meeting could shift how vaccine product information is written and approved, making it easier for pregnant and breast-feeding women to access vaccines with confidence. The published report will serve as a roadmap for funders and regulators, potentially accelerating changes in trial design and labelling that affect millions of women globally. This is not fundamental science but a focused effort to remove a systemic barrier in public health infrastructure.