WHO un­veils first malaria vac­cine in African pi­lot

East African Business Week - - HEALTH -

GENEVA, SWITZER­LAND- The world’s first malaria vac­cine was rolled out in pi­lot projects in sub-sa­ha­ran Africa last week the World Health Or­gan­i­sa­tion (WHO) has con­firmed writes SA­MUEL NABWIISO.

The vac­cine, known as RTS,S, acts against P. fal­ci­parum, the most deadly malaria par­a­site glob­ally, and the most preva­lent in Africa. Ad­vanced clin­i­cal tri­als have shown RTS,S to pro­vide par­tial pro­tec­tion against malaria in young chil­dren.

Fund­ing is now se­cured for the ini­tial phase of the pro­gramme and vac­ci­na­tions are due to be­gin in 2018.

Dr Seth Berkley, CEO of Gavi, the Vac­cine Al­liance said, “These pi­lots are crit­i­cal to de­ter­mine whether this vac­cine can be rolled out more broadly, ad­ding an im­por­tant new tool to the proven in­ter­ven­tions we al­ready have in the fight against malaria.

“The Global Fund’s com­mit­ment marks the be­gin­ning of a his­toric part­ner­ship be­tween Gavi, the Global Fund and UNITAID, bring­ing to­gether three of the world’s big­gest health fi­nanc­ing in­sti­tu­tions to tackle one of the lead­ing killers of chil­dren,” he said.

Dr Pe­dro Alonso, Di­rec­tor of the WHO Global Malaria Pro­gramme said, “The pi­lot de­ploy­ment of this first-gen­er­a­tion vac­cine marks a mile­stone in the fight against malaria.

“These pi­lot projects will pro­vide the ev­i­dence we need from real-life set­tings to make in­formed de­ci­sions on whether to de­ploy the vac­cine on a wide scale,” he said.

The Global Fund to Fight AIDS, Tu­ber­cu­lo­sis and Malaria last week ap­proved $15 mil­lion for the malaria vac­cine pi­lots, as­sur­ing full fund­ing for the first phase of the pro­gramme.

Ear­lier this year, the Gavi, the Vac­cine Al­liance and UNITAID an­nounced com­mit­ments of up to $27.5 mil­lion and $9.6 mil­lion, re­spec­tively, for the first 4 years of the vac­cine pro­gramme.

RTS,S was de­vel­oped through a part­ner­ship be­tween Glax­o­smithK­line and the PATH Malaria Vac­cine Ini­tia­tive (MVI), with sup­port from the Bill & Melinda Gates Foun­da­tion and from a net­work of African re­search cen­tres.

“WHO rec­og­nizes and com­mends the lead­er­ship and sup­port of all fund­ing agen­cies and part­ners who have made this achieve­ment pos­si­ble,” Dr Jean-marie Okwo-bele, Di­rec­tor of the WHO Depart­ment of Im­mu­niza­tion, Vac­cines and Bi­o­log­i­cals said.

In Oc­to­ber 2015, two in­de­pen­dent WHO ad­vi­sory groups com­prised of the world’s fore­most ex­perts on vac­cines and malaria – the Strate­gic Ad­vi­sory Group of Ex­perts (SAGE) on Im­mu­niza­tion and the Malaria Pol­icy Ad­vi­sory Com­mit­tee (MPAC) – rec­om­mended pi­lot im­ple­men­ta­tion of the RTS,S vac­cine in 3 to 5 set­tings in sub-sa­ha­ran Africa. These rec­om­men­da­tions fol­lowed a July 2015 an­nounce­ment that the Euro­pean Medicines Agency (EMA) had is­sued a pos­i­tive sci­en­tific opin­ion of the RTS,S vac­cine.

WHO of­fi­cially adopted the SAGE-MPAC rec­om­men­da­tions in Jan­uary 2016 and has since worked to mo­bi­lize fi­nan­cial sup­port for the pi­lots and to fi­nal­ize the pro­gramme de­sign. The pi­lot pro­gramme will eval­u­ate the fea­si­bil­ity of de­liv­er­ing the re­quired 4 doses of RTS,S; the im­pact of RTS,S on lives saved; and the safety of the vac­cine in the con­text of rou­tine use.* It will also as­sess the ex­tent to which the vac­cine’s pro­tec­tive ef­fect demon­strated in chil­dren aged 5–17 months old in the Phase 3 trial can be repli­cated in real-life set­tings.

RTS,S is the first malaria vac­cine to suc­cess­fully com­plete piv­otal Phase 3 test­ing. The Phase 3 trial en­rolled more than 15,000 in­fants and young chil­dren in 7 coun­tries in sub-sa­ha­ran Africa. Coun­tries that par­tic­i­pated in the Phase 3 clin­i­cal tri­als will be pri­or­i­tized for in­clu­sion in the WHO pi­lot pro­gramme. Con­sul­ta­tions are on­go­ing and the names of the three se­lected coun­tries will be an­nounced in the com­ing weeks.

The RTS,S vac­cine is pro­posed as a tool to com­ple­ment the ex­ist­ing pack­age of Who-rec­om­mended malaria pre­ven­tive, di­ag­nos­tic and treat­ment mea­sures and will be used in com­bi­na­tion with the cur­rent in­ter­ven­tions. Other tools in­clude: long-last­ing in­sec­ti­ci­dal bed-nets, spray­ing in­side walls of dwellings with in­sec­ti­cides, pre­ven­tive treat­ment for in­fants and dur­ing preg­nancy, prompt di­ag­nos­tic test­ing, and treat­ment of con­firmed cases with ef­fec­tive anti-malar­ial medicines.

De­ploy­ment of these tools has al­ready dra­mat­i­cally low­ered malaria dis­ease bur­den in many African set­tings. Be­tween 2000 and 2015, the rate of new malaria cases in sub-sa­ha­ran Africa fell by 42% and malaria mor­tal­ity rates fell by 66%. How­ever, this re­gion con­tin­ues to ac­count for ap­prox­i­mately 90% of global malaria cases and deaths.

As RTS,S is only par­tially ef­fec­tive, it will be es­sen­tial that any vac­ci­nated pa­tients with a fever be tested for malaria, and that all those with a con­firmed malaria di­ag­no­sis are treated with high qual­ity, ef­fec­tive anti-malar­ial medicines.

Mark Dy­bul, Ex­ec­u­tive Di­rec­tor of the Global Fund said, “The new vac­cine is a po­ten­tially valu­able new tool in the fight against malaria.”

An ef­fec­tive vacinne would be vi­tal be­cause sub-sa­ha­ran Africa con­tin­ues to ac­count for ap­prox­i­mately 90% of global malaria cases and deaths.

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