priMe AVAREF Meeting
It is our pleasure to announce that our pivotal phase III infant vaccine trial was accepted by the African Vaccine Regulatory Forum (AVAREF) for a joint review process.
The aim of the joint review via AVAREF is to improve harmonization of regulatory requirements, practice and processes across countries, as well as capacity building for more efficient regulatory oversight.
The joint review meeting was successfully held in Nairobi, Kenya on 22-24th of January 2020 by the participation of national regulatory authorities and ethics committees from South Africa, Kenya, Uganda and Tanzania (except the ethics committees from South Africa), as well as Serum Institute of India Private Limited, International AIDS Vaccine Initiative and Vakzine Projekt Management, as applicant.
National regulatory authorities and ethics committees collectively prepared a consolidated list of questions for the applicant. The candidate product, trial design, safety and other aspects of the proposed pivotal trial were directly discussed with the respective authorities.
During the meeting the protocol has been discussed extensively and the trial design, the objectives and endpoints have been approved by AVAREF and all countries.