Years after Sanofi’s Dengvaxia fiasco, Takeda lands first OK for its own dengue vaccine – Endpoints News

Take­da has scored a land­mark ap­proval for its dengue vac­cine, the first step in help­ing tack­le what the WHO has de­fined as a top 10 health prob­lem and crack­ing open a po­ten­tial block­buster mar­ket.
In­done­sia ap­proved the vac­cine, for­mer­ly known as TAK-003 and now brand­ed Qden­ga, for the pre­ven­tion of dengue dis­ease re­gard­less of pri­or dengue ex­po­sure.
The broad la­bel is key, be­cause while Sanofi lays claim to the world’s first dengue vac­cine, the roll­out of its shot, Deng­vax­ia, im­plod­ed amid a pub­lic health scan­dal. In late 2017, af­ter the Philip­pines al­ready pur­chased $70 mil­lion worth of Deng­vax­ia and be­gan a mass vac­ci­na­tion cam­paign, it emerged that the vac­cine ac­tu­al­ly car­ried a life-threat­en­ing risk for those who have nev­er had a dengue in­fec­tion. The Fil­ipino gov­ern­ment sus­pend­ed the cam­paign and sued Sanofi, which even­tu­al­ly con­ced­ed the risks.
Al­though Deng­vax­ia did go on to earn an FDA ap­proval, it was lim­it­ed to young peo­ple who’ve had lab­o­ra­to­ry-con­firmed dengue dis­ease.
Un­der that cloud, Take­da has been care­ful­ly col­lect­ing da­ta on both seropos­i­tive — pre­vi­ous­ly in­fect­ed — and seroneg­a­tive pop­u­la­tions, break­ing down the num­bers every step of the way to en­sure that its vac­cine wouldn’t re­peat the same mis­take.

On their re­cent quar­ter­ly call, ex­ecs not­ed that fol­low-up da­ta out to 4.5 years sug­gest the vac­cine still holds up.
“While mor­tal­i­ty from dengue is rel­a­tive­ly low, se­vere dengue in­fec­tion can be dev­as­tat­ing for pa­tients, some­times lead­ing to hos­pi­tal­iza­tion,” R&D chief Andy Plump said on the call, adding:
Gary Du­bin
For re­gions that ex­pe­ri­ence a dengue epi­dem­ic, hos­pi­tals can be­come over­run with pa­tients, re­quir­ing sup­port­ive care. And so, the sec­ondary con­se­quences for pa­tients with oth­er dis­eases can be sub­stan­tial, not un­like what we have seen with COVID. There is an in­cred­i­ble un­met med­ical need, and we are ready to meet that need with a re­al­ly good vac­cine. Our 4.5-year da­ta con­tin­ued to sup­port sus­tained ef­fi­ca­cy. What we show here with pa­tients at base­line who are seropos­i­tive or seroneg­a­tive is an in­cred­i­ble 84% re­duc­tion in hos­pi­tal­iza­tion. Hos­pi­tal­iza­tion is an in­di­ca­tor of se­vere forms of dengue.
And the In­done­sia OK is just a start, with an EU de­ci­sion ex­pect­ed lat­er this year.
“Dengue can af­fect any­one liv­ing in or trav­el­ing to en­dem­ic ar­eas – re­gard­less of age, health and so­cio-eco­nom­ic cir­cum­stances,” said Gary Du­bin, pres­i­dent of Take­da’s vac­cine busi­ness unit.