WHO preferred product characteristics for monoclonal antibodies for HIV prevention

Overview

It is a priority for WHO to ensure that products are developed in a manner that supports optimal use globally, including in low- and middle-income countries (LMICs). To support this goal, preferred product characteristics (PPCs) technical documents are developed to articulate preferred attributes of products for licensure, policy and programmatic implementation in LMICs settings. PPCs are developed based on criteria that include feasibility and unmet medical need for prevention interventions in WHO priority disease areas.

The primary target audience for WHO PPCs is any entity intending to seek eventual WHO policy recommendation and prequalification for their products. WHO PPCs do not override existing WHO guidance and are meant to be updated regularly to account for changes in the prevention and research and development landscape. PPCs do not include minimally acceptable characteristics. Regardless of whether a product candidate meets PPC criteria, it can still be assessed by WHO for policy recommendation. The current PPC addresses the preferred product attributes for monoclonal antibodies (mAbs) for HIV-1 prophylaxis (table 1). PPCs that address the preferred product attributes for HIV vaccines are also a key priority.