The Introduction of

Dengue Vaccine
Richard T. Mahoney, PhD
richardtmahoney@gmail.com

Dengue is Important
Recent studies from Oxford suggest as many as 390
million infections per year
Dengue is the only major infectious disease that is
growing rapidly
There are no drugs or vaccines, and vector control
has not been successful
The burden of dengue is on health, society, and
economics
Dengue has long been underappreciated because of
reliance on DALYs

Vaccine Development
Development has been slow: need to protect
against four viruses (DEN1-4), interference in live
attenuated vaccines, lack of an animal model, low
priority.
By 2020 there should be several vaccines available
2015
2017
2019
2019

Sanofi Pasteur (live attenuated)

Takeda and Butantan/NIH (live attenuated)
Merck (subunit) originally developed in Hawaii
GSK/Fiocruz/Walter Reed (purified inactivated)

Introduction Failure
"A decade after each study vaccine or malaria
intervention was approved by regulators, 33%
or fewer lower and lower-middle income
countries, and in most cases less than 15%, had
begun to implement it.... The mean of the
percentage of low income countries beginning
implementation of each intervention after five
years was 3% and 20% after 10 years.... No low
income country implemented any of the new
vaccines in the first five years."
Source: Brooks A, Smth TA, de Savigny D, Lengeler C. Implementing new health
interventions in developing countries: why do we lose a decade or more? BMC
Public Health. 2012; 12(683): 17.

Important Framework
Access has not been well understood and has not, in my
view, received the priority it deserves and which the
failure to introduce abundantly demonstrates
There are several reasons
Very few donor staff come out of an access, e.g.
marketing, background. Most often epi, lab or clinic.
Access is very complex as illustrated by the Framework
Access professionals have not done a good job of clarifying
strategies and priorities.

The Framework nicely divides pre-licensure work from

post-licensure work making it easier to see the priority
areas.

Regulatory Oversight
Bring together regulators from likely first
adopter countries to examine issues in detail
and discuss likely requirements for dossiers
Forge an agreement among likely first
adopter countries for joint review of dossiers

Forecasting
Develop comprehensive models of dengue
vaccine introduction comparing large number
of introduction strategies allowing countries
to understand what strategies will likely have
the greatest impact on disease.
Develop comprehensive models of dengue
vaccine demand by country given supply
constraints allowing countries to refine
strategies

Global Decision Making

Work with WHO to prepare all necessary
documents for SAGE review so that a SAGE
recommendation can be ready as soon as
licensure is achieved.

Economics
Prepare a credible cost of goods study to
provide assistance to procurement agencies
in negotiating purchase prices.
We showed that COG should be much less
that $1.00 per dose at Butantan facility.

Summary
After more than 70 years of effort it is likely that
several vaccines will be available for introduction by
2020 with one in 2015.
The public sector has been very poor in introducing
new technologies particularly to the poorest
countries.
A clear and workable strategy for accelerating
introduction is needed in light of limited resources
A Framework such as proposed here could help assure
a more rapid impact on the dengue burden of disease.