PDR provides normative guidance and consensus generation to accelerate vaccine development, evaluation and policy generation through a number of initiatives.

Research and Product Development by Disease

PDR supports research and vaccine and/or monoclonal antibody development activities related to a number of infectious diseases. Information on Vaccines and monoclonal antibodies in development can be accessed through the IVB disease pages:

Global Vaccine and Immunization Research Forum (GVIRF)

The Global Vaccine and Immunization Research Forum (GVIRF) is the central discussion platform of all research and innovation aspects related to the Immunization Agenda 2030, and specifically Strategic Priority 7, Research and Innovation. GVIRF is co-hosted by WHO, the US National Institute of Allergy and Infectious Diseases, and the Bill & Melinda Gates Foundation. Gathering leading experts from public health, academia, government, civil society and the private sector, the GVIRF is held every second year. The next meeting will be in Brazil in 2025.

Between meetings, GVIRF Webinars are exploring late-breaking developments for specific topics, such as mRNA vaccine technologies and malaria vaccines.

Preferred Product Characteristics and Target Product Profiles

WHO Preferred Product Characteristics (PPCs) and Target Product Profiles (TPPs), published by IVB, provide information on preferential product attributes for vaccines and monoclonal antibodies to be used in low- and middle-income country settings.  WHO PPCs and TPPs are pathogen-specific and intended to inform candidate specific TPPs developed by vaccine developers. They aim to encourage innovation and promote development of products for use in settings most relevant to the global unmet public health needs. The primary target audience for WHO PPCs and TPPs is any entity intending to eventually seek WHO policy recommendation and prequalification (PQ) for their products.

Evidence Considerations for Vaccine Policy (ECVP)

The proposed WHO Evidence Considerations for Vaccine Policy (ECVP) development aims to provide early information on the data and evidence that is anticipated to be needed to support country-level, regional and WHO global policy making for new vaccines in priority disease areas. Examples of such data could include specific populations (distinct from the target population) that could be prioritized for a particular context, vaccine implementation related parameters and additional data that may influence policy considerations, such as potential impact on anti-microbial resistance.

Full Vaccine Value Assessment (FVVA)

The pathway from vaccine product concept, through development, licensure and deployment is costly and inherently risky for manufacturers, particularly for vaccines against diseases where the burden is predominantly in LMICs. 

In resource-constrained settings, an increasingly compelling rationale will be needed to justify the inclusion of these new vaccines within immunization programmes, over and above many other priorities. As such, the ability to guarantee the global demand, and the willingness to procure at the end of a costly product development pathway is uncertain, and vaccine manufacturers often prioritize high-income markets that offer a more immediate return on investment.  The result can be a delay between vaccine licensure and access to these vaccines by low- and middle-income countries (LMICs), where there is the greatest public health need.

Novel Delivery Technologies

Despite more vaccines being delivered year on year, the global vaccine coverage rate has plateaued and inequities in coverage persist.  Many LMICs fall well below global coverage targets, and 51% of countries have stagnant or declining coverage. Complex vaccine delivery technologies contribute to these challenges. Vaccine product innovations that ease delivery in resource-constrained settings are urgently needed to achieve the IA2030 goals on equitable vaccination coverage. To enhance research in this area, PDR works to advance delivery technology development and uptake of innovative vaccine delivery technologies.

Monoclonal Antibodies for Infectious Diseases

PDR has a project exploring the use of monoclonal antibodies (mAbs) in infectious diseases to provide passive immunization, with a particular focus on HIV, influenza, polio, rabies and RSV.

Vaccines for Antimicrobial Resistance (AMR)

Vaccines are important tools to prevent antimicrobial resistance and can do so in multiple ways. Vaccines prevent infections with drug sensitive and drug resistant pathogens thereby limiting the chances of a drug resistance from developing and spreading further. By preventing infections and their associated symptoms vaccines can limit antibiotic use, a key driver of resistance. PDR is pursuing the agenda to understand, evaluate and communicate the role of vaccines against AMR through several workstreams.

Burden of Enteric Diseases

To articulate the full value of vaccines, WHO has conducted analyses to better understand the mortality associated with enteric infections, investigated methodologies to calculate such burden, and provided recommendations for future modelling studies. In addition to mortality, repeated enteric infections and diarrhoea result in malnutrition and are often associated with long-term morbidity such as growth faltering and cognitive outcomes. WHO is undertaking workstreams to better understand the impact of enteric infections on morbidity to inform decisions about vaccine development, introduction and use.

Roadmaps

Vaccine development technology roadmaps are pathogen-specific and aim to highlight priority activities for vaccine researchers, funders and product developers, with the goal to accelerate the pathway to availability and access in low- and middle-income countries (LMICs). Roadmaps have been developed for several pathogens and can be accessed under research by disease.

Product Development for Vaccines Advisory Committee

Established in 2014, the Product Development for Vaccines Advisory Committee (PDVAC) is an independent standing WHO committee of experts which provides external advice to WHO related to priority infectious disease pathogens, associated vaccine and monoclonal antibody approaches and related manufacturing and delivery technologies. The committee’s remit covers disease areas where there is, or may be, substantial disease burden in low- and middle-income countries (LMICs), where no vaccine related products currently exist, but where there is ongoing product development activity which may benefit from WHO guidance, or technologies that could expedite availability and access of vaccine products in LMICs. PDVAC may also have a role where vaccines are already licensed, and development of improved products, including those based on novel manufacturing technologies or innovative vaccine delivery approaches is a priority for WHO and its member states.

Product Development for Vaccines Advisory Committee