The Need for Structured Guidance in Emergencies
In the midst of an emerging infectious disease outbreak, decision-makers face intense pressure to evaluate vaccines rapidly. For pregnant and lactating individuals, who are often excluded from early clinical trials, this creates a serious evidence gap.
To help bridge that gap, the SPEAC Special Populations Working Group has developed a new template tool that provides a structured, early-stage framework for evaluating whether a candidate vaccine may be appropriate for use in these populations.
Now published in Vaccine, this tool supports decision-makers—regulators, sponsors, researchers, and ethics boards—by offering a standardized set of criteria to assess potential risks and benefits before more robust clinical data become available.
Read the article:
A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women
Key Features of the Tool
- Designed for early-stage, outbreak response scenarios
- Promotes transparency and reproducibility
- Addresses key data gaps relevant to maternal immunization
- Informed by prior experience with COVID-19, Zika, and other emerging threats
Why It Matters
By providing consistent, evidence-based guidance, this tool can help ensure that pregnant and breastfeeding individuals are not left behind in vaccine policy decisions—especially during fast-moving public health emergencies.
The SPEAC team is committed to advancing vaccine safety science that is inclusive, equitable, and ready for the next outbreak.
