The Introduction of Dengue Vaccine

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    The Introduction of

    Dengue VaccineRichard T. Mahoney, [email protected]

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    Dengue is Important

    Recent studies from Oxford suggest as many as !"million infections per year

    Dengue is the only ma#or infectious disease that isgro$ing rapidly

    There are no drugs or %accines, and %ector controlhas not &een successful

    The &urden of dengue is on health, society, andeconomics

    Dengue has long &een underappreciated &ecause ofreliance on D'()s

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    Vaccine De%elopment

    De%elopment has &een slo$* need to protectagainst four %iruses +D-/01, interference in li%eattenuated %accines, lac2 of an animal model, lo$

    priority.

    3y 4"4" there should &e se%eral %accines a%aila&le

    4"5 6 7ano8 Pasteur +li%e attenuated1

    4"9 6 Ta2eda and 3utantan:-I; +li%e attenuated1

    4"! 6 Merc2 +su&unit1 originally de%eloped in ;a$aii

    4"! 6 iocru?:alter Reed +puri8ed inacti%ated1

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    Introduction >ailure

    A' decade after each study %accine or malariainter%ention $as appro%ed &y regulators, B

    or fe$er lo$er and lo$er/middle incomecountries, and in most cases less than 5B, had&egun to implement it.... The mean of thepercentage of lo$ income countries &eginningimplementation of each inter%ention after 8%e

    years $as B and 4"B after " years.... -o lo$income country implemented any of the ne$%accines in the 8rst 8%e years.A

    7ource* 3roo2s ', 7mth T', de 7a%igny D, (engeler C. Implementing ne$ healthinter%entions in de%eloping countries* $hy do $e lose a decade or more 3MC

    Pu&lic ;ealth. 4"4E12

    +FG1* 9.

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    Important >rame$or2

    'ccess has not &een $ell understood and has not, in my%ie$, recei%ed the priority it deser%es and $hich thefailure to introduce a&undantly demonstrates

    There are se%eral reasons

    Very fe$ donor staH come out of an access, e.g.mar2eting, &ac2ground. Most often epi, la& or clinic.

    'ccess is %ery complex as illustrated &y the >rame$or2

    'ccess professionals ha%e not done a good #o& of clarifyingstrategies and priorities.

    The >rame$or2 nicely di%ides pre/licensure $or2 frompost/licensure $or2 ma2ing it easier to see the priorityareas.

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    Regulatory O%ersight

    3ring together regulators from li2ely 8rstadopter countries to examine issues in detailand discuss li2ely reuirements for dossiers

    >orge an agreement among li2ely 8rstadopter countries for #oint re%ie$ of dossiers

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    >orecasting

    De%elop comprehensi%e models of dengue%accine introduction comparing large num&erof introduction strategies allo$ing countriesto understand $hat strategies $ill li2ely ha%ethe greatest impact on disease.

    De%elop comprehensi%e models of dengue

    %accine demand &y country gi%en supplyconstraints allo$ing countries to re8nestrategies

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    conomics

    Prepare a credi&le cost of goods study topro%ide assistance to procurement agenciesin negotiating purchase prices.

    e sho$ed that CO< should &e much lessthat J."" per dose at 3utantan facility.

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    7ummary

    'fter more than 9" years of eHort it is li2ely thatse%eral %accines $ill &e a%aila&le for introduction &y

    4"4" $ith one in 4"5.

    The pu&lic sector has &een %ery poor in introducingne$ technologies particularly to the poorestcountries.

    ' clear and $or2a&le strategy for accelerating

    introduction is needed in light of limited resources

    ' >rame$or2 such as proposed here could help assurea more rapid impact on the dengue &urden of disease.