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Background:  The RTS,S/AS01  E  malaria vaccine is being assessed in Malawi, Ghana and Kenya as part of a large-scale pilot implementation programme. Even if impactful, its incorporation into immunisation programmes will depend on demonstrating cost-effectiveness. We analysed the cost-effectiveness and public health impact of the RTS,S/AS01  E  malaria vaccine use in Malawi.   Methods:  We calculated the Incremental Cost Effectiveness Ratio (ICER) per disability-adjusted life year (DALY) averted by vaccination and compared it to Malawi’s mean per capita Gross Domestic Product. We used a previously validated Markov model, which simulated malaria progression in a 2017 Malawian birth cohort for 15 years. We used a 46% vaccine efficacy, 75% vaccine coverage, USD5 estimated cost per vaccine dose, published local treatment costs for clinical malaria and Malawi specific malaria indicators for interventions such as bed net and antimalarial use. We took a healthcare provider, household and societal perspective. Costs were discounted at 3% per year, no discounting was applied to DALYs. For public health impact, we calculated the DALYs, and malaria events averted.   Results:  The ICER/DALY averted was USD115 and USD109 for the health system perspective and societal perspective respectively, lower than GDP per capita of USD398.6 for Malawi. Sensitivity analyses exploring the impact of variation in vaccine costs, vaccine coverage rate and coverage of four doses showed vaccine implementation would be cost-effective across a wide range of different outcomes. RTS,S/AS01 was predicted to avert a median of 93,940 (range 20,490–126,540) clinical cases and 394 (127–708) deaths for the three-dose schedule, or 116,480 (31,450–160,410) clinical cases and 484 (189–859) deaths for the four-dose schedule, per 100 000 fully vaccinated children.   Conclusions:  We predict the introduction of the RTS,S/AS01 vaccine in the Malawian expanded programme of immunisation (EPI) likely to be highly cost effective.

Cost-effectiveness and public health impact of RTS,S/AS01E malaria vaccine in Malawi, using a Markov static model