WHO Evidence Considerations for Vaccine Policy Development for Tuberculosis Vaccines Intended for Adults and Adolescents

Overview

This ECVP for TB vaccines intended for adults and adolescents is the first ECVP to be developed. The primary audience for this ECVP includes all stakeholders intending to support the product development, regulatory approval, introduction, access and widespread use in LMICs of new TB vaccines intended for use in adults and adolescents.

The TB vaccine ECVP includes five Tables summarizing:

1. Vaccine product-related considerations, which build upon and expand existing WHO Preferred Product Characteristics for TB vaccines intended for adults and adolescents, and include priority population(s), i.e., the populations who will be the primary recipients of the vaccine after approval.
2. Vaccine delivery-related considerations, which cover aspects such as the delivery setting, thermostability and presentation.
3. Other target populations, beyond the priority population/s for which the vaccine may receive an initial policy recommendation following regulatory approval. This section identifies additional target populations for introduction, once there is sufficient safety and vaccine effectiveness data.
4. Regulatory strategy considerations, the potential approval pathways available for this category of TB vaccines and the potential stakeholders that need to be engaged.
5. Implementation considerations, the data and evidence beyond that required for regulatory approval that will likely be important for global policy, financing and vaccine-introduction decisions
   

The ECVP does not pre-empt policy or implementation decision-making but aims to reduce the risk of evidence gaps and consequent delays between vaccine regulatory approval and vaccine impact.