Meeting of the joint technical expert group (JTEG) on malaria vaccines in pivotal phase 3 Evaluation
9 October 2012, Geneva, Switzerland
The Joint Technical Expert Group (JTEG) on Malaria Vaccines in Pivotal Phase 3 Evaluation is constituted and convened jointly by the World Health Organization's Initiative for Vaccine Research (WHO/IVB/IVR) and the WHO Global Malaria Programme.
JTEG meetings are organized with close involvement of the AFRO Regional Office, with vaccine regulatory and AFRO/malaria teams acting as part of the JTEG secretariat. JTEG serves in place of a SAGE immunization working group on malaria vaccines, as well as serving as the malaria vaccine Technical Expert Group working with the Malaria Policy Advisory Committee of the Global Malaria Programme.
The purpose of the meeting was to:
- Review in-confidence the first Phase 3 data for the most advanced candidate malaria vaccine, RTS,S/AS01, from the target population of 6-14 week old infants.
- Prepare briefings and external communications for the time of public disclosure of these results in November 2012.
- Ensure good communication between European Medicines Agency, African National Regulatory Authorities and the WHO policy process.
- Advice to WHO on JTEG's assessment of safety, immunogenicity and efficacy of RTS,S/AS01 based on the analyses available to date.
- Advance the WHO policy process towards potential recommendations on use of the first malaria vaccine in 2015.
Expected outcomes
- Adequate preparation for SAGE April 2013 session. This will allow firm plans to be made for other needed interactions with GACVS and with the malaria department committee known as Malaria Policy Advisory Committee, and will allow communication of the WHO 2015 policy timings.
- Advice from JTEG on WHO’s external communications at the time of public disclosure of these Phase 3 results in November 2012
- Updated WHO staff briefings, malaria vaccine Q&A, and other communication material.