23-24 February 2012: Joint Technical Expert Group (JTEG) meeting on Malaria Vaccines in Pivotal Phase 3 Evaluation
The most advanced first generation malaria vaccine is GSK’s RTS,S/AS01. This vaccine started phase 3 evaluation in May 2009. The regulatory pathway is submission to EMA with article 58 WHO involvement. The first of three planned Phase 3 analyses will be made available to WHO in the fourth quarter of 2011. The final planned analysis, including data potentially sufficient to consider policy recommendation is currently expected in 2014. All other malaria vaccine candidates are at least 3-5 years behind in their clinical development plans.
In order to prepare a review of the evidence which will need to be presented to SAGE, IVR and the WHO Global Malaria Programme jointly convened the third JTEG meeting, with observers from EMA and AVAREF and a liaison present from SAGE.
Meeting objectives included:
- briefing on the status of new data regarding RTS,S/AS01 that has become available since the second meeting;
- briefing on planned Phase 4 studies of safety and effectiveness;
- briefing on the reporting and analysis plan for all data packages;
- provide advice to WHO on JTEG's assessment of safety, immunogenicity and efficacy of RTS,S/AS01 based on the analyses available to date; and
- briefing on JTEG's assessments to EMA and AVAREF observers.
At the end of this meeting it was expected that adequate preparation for availability of data on clinical malaria in the target population, and availability of data on persistence of protection, and protection across a representative range of transmission settings would be made available from October 2012 - December 2014.