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.