The AACVS agreed that the safety evaluation data presented by MVIP programme seemed to be robust and the sources of data seemed appropriate and sufficiently diverse to answer safety questions about the RTS,S/AS01 vaccine raised by the SAGE and MPAG. No safety signals, trends or clusters of AEFIs associated with the RTS,S/AS01 vaccine were reported by the MVIP evaluation or the national routine passive surveillance systems. They concluded that there was no evidence of causal associations between the RTS,S/AS01 vaccine and meningitis, cerebral malaria or gender mortality imbalance based on the safety evaluation presented by MVIP. The AACVS recommended that the pharmacovigilance systems in the African region need to continue to improve and be strengthened for continuous adverse event reporting, data collection, causality assessment. The definitions and classification used to collect data for AEFIs should be harmonized between countries. Funding for routine surveillance is needed and longterm sustainability needs to be considered with country ownership. They also recommend that support for the existing networks of sentinel hospital sites (which are currently used for other vaccines) as well as the laboratories should be continued, if funding allows, to enable the sentinel hospital surveillance for AEFIs and AESIs to be continue.

GACVS agreed with the conclusions of the MVIP DSMB and the AACVS based on the initial data analysis from the extensive pilot programme, i.e., that the data for the 3 safety signals (meningitis, cerebral meningitis and imbalance of mortality in females) is reassuring, with no evidence of any safety signal. They noted the good RTS,S/AS01vaccination uptake and the absence of any negative impact on the EPI coverage or other malaria preventive measures. GACVS applauded the hard work and efforts that have enabled the robust assessment of the safety of the RTS,S/AS01 vaccine in the 3 countries participating in the MVIP pilot evaluations. GACVS understands that the MVIP pilot evaluations will continue for another 2 years, as planned and the final results will be considered. GACVS acknowledged that GSK’s post-marketing evaluation is ongoing and will continue, with a planned interim analysis due in 2023 and the final analysis in 2025. GACVS noted the current limitations of the routine passive surveillance systems in countries where the RTS,S/AS01 vaccine was introduced, as well as in countries where it may be introduced more widely, if recommended by WHO. They strongly recommended that efforts to strengthen these surveillance systems should be continued. GACVS reiterated more generally that sentinel surveillance systems should be considered for all new vaccine introduction, including for the RTS,S/AS01 vaccine, when possible, and at least, an enhanced passive surveillance with active follow up and causality assessment of AEFIs of potential interest. GACVS stated that these recommendations for strengthening surveillance systems are not intended to be a pre-requisite or barrier for expanding use of the RTS,S/ AS01 vaccine.