World’s first malaria vac­cine gets go-ahead

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The world’s first malaria vac­cine got a green light on Fri­day from Euro­pean drugs reg­u­la­tors who rec­om­mended it as safe and ef­fec­tive to use in ba­bies in Africa at risk of the mos­quito-borne dis­ease. The shot, called Mosquirix and de­vel­oped by Bri­tish drug­maker Glax­oSmithK­line in part­ner­ship with the PATH Malaria Vac­cine Ini­tia­tive, would be the first li­censed hu­man vac­cine against a par­a­sitic dis­ease and could help pre­vent mil­lions of cases of malaria in coun­tries that use it.

Mosquirix, also part-funded by the Bill & Melinda Gates Foun­da­tion, will now be as­sessed by the World Health Or­ga­ni­za­tion, which has promised to give its guid­ance be­fore the end of this year on when and where it could be used. Malaria in­fects around 200 mil­lion peo­ple a year and killed an es­ti­mated 584,000 in 2013, the vast ma­jor­ity of them in sub-Sa­ha­ran Africa. More than 80 per­cent of malaria deaths are in chil­dren un­der the age of five.

An­drew Witty, GSK’s chief ex­ec­u­tive, said EMA’s pos­i­tive rec­om­men­da­tion was a fur­ther im­por­tant step to­wards mak­ing the world’s first malaria vac­cine avail­able.

“While RTS,S on its own is not the com­plete an­swer to malaria, its use along­side those in­ter­ven­tions such as bed nets and in­sec­ti­cides would pro­vide a very mean­ing­ful con­tri­bu­tion to con­trol­ling the im­pact of malaria on chil­dren in those African com­mu­ni­ties that need it the most,” he said in a state­ment.

Global health ex­perts have long hoped sci­en­tists would be able to de­velop an ef­fec­tive malaria vac­cine, and re­searchers at GSK have been work­ing on RTS,S for 30 years.

The shot also con­tains an ad­ju­vant, or booster, made by US biotech com­pany Agenus.

Hopes that Mosquirix would be the fi­nal an­swer to wip­ing out malaria were damp­ened when trial data re­leased in 2011 and 2012 showed it re­duced episodes of malaria in ba­bies aged 6-12 weeks by only 27 per­cent, and by around 46 per­cent in chil­dren aged 5-17 months.

EMA’s rec­om­men­da­tion is that the shot should nev­er­the­less be li­censed for use in ba­bies in the full age range cov­ered in the tri­als - from 6 weeks to 17 months.

Some malaria spe­cial­ists have ex­pressed con­cern that the com­plex­i­ties and po­ten­tial costs of de­ploy­ing this first vac­cine when it pro­vides only par­tial pro­tec­tion make it less at­trac­tive and more risky.

“The tim­ing, du­ra­tion, and out­comes of some of the crit­i­cal steps to pos­si­ble vac­cine im­ple­men­ta­tion in African coun­tries are not yet known,” said David Kaslow, PATH’s vice pres­i­dent of prod­uct de­vel­op­ment.

How­ever Joe Co­hen, a GSK sci­en­tist who has led the de­vel­op­ment of Mosquirix since 1987, said on Fri­day he has no doubt the vac­cine could sig­nif­i­cantly re­duce the toll of sick­ness and death caused by the malaria among African chil­dren. “I have ab­so­lutely no reser­va­tions in terms of rolling this vac­cine out,” he told Reuters.

“Why? Be­cause the ef­fi­cacy, when trans­lated into cases averted and deaths averted, is just tremen­dous. It will have an enor­mously sig­nif­i­cant public health im­pact.”

GSK has promised it will make no profit from Mosquirix, pric­ing it at the cost of man­u­fac­ture plus a 5 per­cent mar­gin which it will rein­vest in re­search on malaria and other ne­glected trop­i­cal dis­eases.

Sources in­volved in plan­ning for Mosquirix’s po­ten­tial fu­ture use have told Reuters they’ve been ad­vised to work with a price tag of around $5 per dose, which would bring the cost of a rec­om­mended four-dose im­mu­ni­sa­tion to $20.

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