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Ghana Malaria Vaccine Technical Brief Summary

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Ghana Malaria Vaccine Technical Brief Summary Ghana malaria vaccine technical brief summary Purpose Health Survey) have shown endemicity ranging from intermittent transmission in the Greater Accra Region to In January 2016, Ghana responded to the World Health intense seasonal transmission in the Upper West Region Organization (WHO) call for national ministries of health and seasonal transmission in the rest of the country. to express interest in collaborating in the RTS,S/AS01 malaria vaccine pilot implementation programme, Parasite prevalence in children 6 to 59 months of which was reaffirmed in March 2016. Furthermore, the age according to microscopy in 2011 and 2014* WHO is planning a delegation with partners from PATH MICS, 2011 DHS, 2014 and GlaxoSmithKline (GSK) to speak with high level 2011 2011 officials, Ministry of Health and Ghana Health Services (GHS) officials to discuss Ghana’s potential participation in the RTS,S/AS01 malaria vaccine pilot implementation programme. This document is a summary of the RTS,S/AS01 vaccine background, data, and information to support policy and decision-makers make an evidence-based decision on the use of a malaria vaccine in Ghana. This brief was drafted by the Ghana Malaria Vaccine Technical Working Group (TWG), a sub-committee of the National Malaria Control Program (NMCP), composed of representatives from the GHS, WHO, members of academia and multilaterals, and compiled with support from PATH, an international nongovernmental organisation (NGO). *Both surveys were implemented during the peak transmission season: mid-September – mid-December Source: 2011 Multiple Indicator Cluster Survey (MICS) and 2014 Background and rationale Ghana Demographic and Health Survey (DHS) Malaria kills nearly 600,000 people a year globally and causes illness in many more, about 90% of which are in Ghana has made notable progress in malaria prevention sub-Saharan Africa and 83% are children under the age and control with existing interventions, significantly of five.1 In Ghana, malaria causes about 2,000 deaths contributing to a reduction in malaria-related deaths. annually, approximately 48% of which afflict children However, the country continues to have a significant under the age of five, and is a major cause of hospital disease burden and could benefit from the deployment attendance, contributing to an estimated 30% of of additional tools in the fight against malaria. A well- admissions.2 Plasmodium falciparum is the tolerated and effective vaccine with an acceptable predominant malaria parasite in Ghana, causing safety profile could be a potentially important tool for approximately 80 to 90% of severe morbidity and malaria control. mortality, particularly in children under five years of age WHO position and pregnant women. Malaria is generally stable in Ghana and recent studies in 2011 (Multiple Indicator In January 2016, WHO issued a position paper calling for large-scale pilot implementations of RTS,S/AS01 in Cluster Survey) and 2014 (Ghana Demographic and 1 World Malaria Report, 2015 2 Ghana DHIMS2, 2015 children 5 to 9 months of age, alongside other malaria prior to the initiation of vaccination in the pilot control interventions in settings of moderate-to-high implementation programme and Phase IV studies. parasite transmission in Africa. Specifically, “WHO recommends that the pilot implementations use the 4- Vaccine efficacy dose schedule of the RTS,S/AS01 vaccine in 3 to 5 Following the Phase III clinical trial which studied two distinct epidemiological settings in sub-Saharan Africa, age groups, infants aged 6-12 weeks and young children at subnational level, covering moderate-to-high 5-17 months of age at first vaccination; however, the transmission settings,” with three doses administered WHO has recommended use of the vaccine among to children between 5 and 9 months of age, followed by young children (5-17 months) due to higher efficacy and a fourth dose 15–18 months later.3 The pilot projected impact3. implementation programme will compile evidence on the feasibility, impact, and safety of the vaccine Phase III clinical trial efficacy data was analyzed at 12 delivered in country immunization programmes and 18 months following 3-doses of vaccination and at alongside other currently recommended malaria 48 months following 4-doses of vaccination post-dose 1 control measures. among both age groups. Highest efficacy was shown shortly after vaccination, which waned over time (Appendix Table 1). More specifically among children 5- RTS,S/AS01 malaria vaccine 17 months of age: The RTS,S/AS01 malaria vaccine, also known as Mosquirix™, is currently the only candidate malaria Three doses of RTS,S/AS01 reduced clinical malaria vaccine to have received a positive regulatory by approximately half at one year of follow-up, by assessment, which was issued by the European 46% at 18 months of follow-up, and by 26% at 48 Medicines Agency (EMA) Committee for Medicinal months of follow-up, compared to children 6,7 Products for Human Use (CHMP).4 The vaccine immunized with a comparator vaccine. development spanned a 30 year process, initiated in A fourth dose of RTS,S/AS01, administered at 18 1987 by scientists working at GlaxoSmithKline’s (GSK) months after the primary series was shown to laboratories. At present, no regulatory authority in the enhance protection and reduce the number of African region has licensed RTS,S/AS01 for use as a 5 clinical malaria cases by 39% at 48 months of malaria vaccine. follow-up.7 The Phase III efficacy and safety trial of RTS,S/AS01 Efficacy results were achieved on top of existing malaria began in May 2009 and was completed in early 2014 at interventions, such as insecticide-treated bed nets, 11 sites in seven African countries (Burkina Faso, Gabon, which were used by almost 80% of the trial participants. Ghana, Kenya, Malawi, Mozambique, and Tanzania) The RTS,S/AS01 Phase III clinical trial showed that the with 15,459 infants and young children participating— vaccine could provide meaningful public health benefit making this the largest malaria vaccine trial in Africa to by reducing the burden of malaria when used alongside date. currently available interventions such as bed nets and 7 Ghana participated in the Phase III clinical trial, with two insecticides. research centers in Agogo and Kintampo. Currently, Ghana is participating in an RTS,S/AS01 baseline study Vaccine safety through the Kintampo and Navrongo Health Research RTS,S/AS01 displayed an acceptable safety and Centres to evaluate adverse events of specific interest tolerability profile throughout the entire Phase III and making the centers eligible for participation in the clinical trial. Adverse events following immunization RTS,S/AS01 Phase IV studies. These would commence (AEFI) included local reactions (such as pain or swelling), following successful application to national regulatory which were observed more frequently after RTS,S/AS01 authorities by GSK, as RTS,S will need to be licensed administration, compared to children immunized with a comparator vaccine.8 3 World Health Organization. Weekly Epidemiological Record. 2016; 5 WHO Questions and Answers on Malaria Vaccines: 91(4): 33–52. http://www.who.int/immunization/research/development/malaria_ 4 The RTS,S/AS01 vaccine has received a positive Scientific Opinion vaccine_qa/en/ by EMA in accordance with Article 58 of Regulation (EC) No 726/2004 6 The RTS,S Clinical Trials Partnership, PloS Medicine. 2014;11(7): which allows the Agency’s Committee for Medicinal Products for e1001685. Human Use (CHMP) to give opinions, in co-operation with WHO, on 7 RTS,S Clinical Trials Partnership, The Lancet. 2015; 386 (9988): 31– medicinal products for human use that are intended exclusively for 45. markets outside of the European Union (EU). For more information: 8 Alonso P, Aponte J, Aide P, et al. The Lancet. 2007; 370 (9598): http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/d 1543–1551. ocument_ listing/document_listing_000157.jsp, accessed January 2016. 2 The incidence of fever one week after vaccination was Following publication of the Phase III clinical trial results higher in children who received the RTS,S/AS01 vaccine and conclusion of the Article 58 regulatory procedure, than in those receiving the comparator vaccine. In RTS,S/AS01 became the only candidate malaria vaccine some, this resulted in febrile reactions that were to have received a positive regulatory assessment, accompanied by generalized convulsive seizures, but all which was issued by the European Medicines Agency affected fully recovered within seven days. (EMA) Committee for Medicinal Products for Human Use (CHMP).9 The Article 58 process—initiated in July The rates of other serious adverse events seen in the 2014—allowed EMA, in cooperation with WHO, to trial (mainly medical events requiring hospitalization, assess the quality, safety, and efficacy of the RTS,S/AS01 regardless of whether they were considered to be malaria vaccine and its benefit-risk balance. According caused by the study vaccine) were comparable between to the EMA, the CHMP concluded that “…despite its the RTS,S/AS01 and control recipients, except for cases limited efficacy, the benefits of Mosquirix™ outweigh of meningitis and cerebral malaria (which were reported the risks in both age groups studied,” and “the benefits in low numbers) more often in the RTS,S/AS01 group. of vaccination may be particularly important among According to the European Medicines Agency (EMA), children in high-transmission areas in which mortality is the imbalance of meningitis cases is most likely to be a very high.”10 chance finding, as some of these cases occurred years after vaccination without any obvious relationship to vaccination. The increased occurrence of meningitis and risk for severe malaria (including cerebral malaria), will Estimated public health impact and be followed closely in Phase IV studies and the pilot 11 implementations. cost effectiveness of RTS,S/AS01 RTS,S/AS01 vaccine public health impact and cost Malaria case fatality rates for children under effectiveness modelled estimates projected the five years of age from 2010 to 2015 vaccine’s potential to have a substantial public health impact when used alongside other malaria control measures.
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