Background
On 8-10th June 2016, WHO assembled the Product Development for Vaccines Advisory Committee (PDVAC) for its third meeting in Geneva, Switzerland. There have been several significant product development advancements in the nine months since the previous meeting in September 2015:
- the first dengue and malaria vaccines have been licensed or achieved the equivalent of licensure, respectively
- the first phase III trials of a Respiratory Syncytial Virus (RSV) vaccine candidate have commenced in the elderly and pregnant women. As an RSV vaccine could be licensed within the next 5 years, the status of RSV vaccine and monoclonal antibody development was presented to WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization in April 2016, for information,
- the most advanced HIV vaccine candidate met its endpoints in the interim analysis of a Phase II study, and preparations to commence an efficacy study are underway,
- Phase IIb trials of a number TB vaccine candidates are approaching key data points, and there is increased consensus on the importance of preventing pulmonary disease in adolescents and adults as a priority public health need to reduce transmission,
- WHO convened the MERS-Coronavirus R&D community, and a Phase 1 clinical study is now underway,
- Ebola virus vaccines are under WHO Emergency Use Assessment and Listing (EUAL) and have progressed to the point of consideration for licensure in record time,
- Zika has been declared a Public Emergency of International Concern (PHEIC), and there are co-ordinated efforts to develop a vaccine as expeditiously as possible. PDVAC has contributed significantly through a PDVAC working group which has overseen development of a Zika vaccine target product profile (TPP), and regulatory considerations towards phase I and emergency use authorization.
The goals of this third PDVAC meeting were to revisit the pathogen areas where there has been significant progress to report since recommendations from the 2015 meeting, as well as to:
- Review status of vaccine development in 7 new pathogen areas where there has been significant vaccine development advances, or where there is significant disease burden but R&D has stalled,
- Refine the workplan and strategic directions for specific pathogen areas,
- Identify cross-cutting issues that accelerate vaccine development or prepare for policy decisions, for example the need to develop a prequalification process for monoclonal antibodies,
- Consider how to better align PDVAC’s vaccine development activities and strategies with other areas of research, for example the anti-microbial research (AMR) agenda,
- Where appropriate, to define how PDVAC could integrate with other R&D efforts, identify key stakeholders to develop strategic goals, define respective roles, and co-ordinate activities, for example the WHO R&D Blueprint,
- To inform the vaccine development community regarding steps beyond vaccine licensure, and WHO processes for vaccine policy recommendation.
Executive summaries of the meetings as well as the agenda, list of participants and presentations can be found below: