Dengue vaccine: local decisions, global consequences

Abstract As new vaccines against diseases that are prevalent in low- and middle-income countries gradually become available, national health authorities are presented with new regulatory and policy challenges. The use of CYD-TDV – a chimeric tetravalent, live-attenuated dengue vaccine – was recently approved in five countries. Although promising for public health, this vaccine has only partial and heterogeneous efficacy and may have substantial adverse effects. In trials, children who were aged 2–5 years when first given CYD-TDV were seven times more likely to be hospitalized for dengue, in the third year post-vaccination, than their counterparts in the control group. As it has not been clarified whether this adverse effect is only a function of age or is determined by dengue serostatus, doubts have been cast over the long-term safety of this vaccine in seronegative individuals of any age. Any deployment of the vaccine, which should be very cautious and only considered after a rigorous evaluation of the vaccine’s risk–benefit ratio in explicit national and subnational scenarios, needs to be followed by a long-term assessment of the vaccine’s effects. Furthermore, any implementation of dengue vaccines must not weaken the political and financial support of preventive measures that can simultaneously limit the impacts of dengue and several other mosquito-borne pathogens.

[1]  S. Halstead,et al.  Challenges to the Design of Clinical Trials for Live-Attenuated Tetravalent Dengue Vaccines , 2016, PLoS neglected tropical diseases.

[2]  S. Halstead,et al.  Protective and immunological behavior of chimeric yellow fever dengue vaccine. , 2016, Vaccine.

[3]  D. Cummings,et al.  Comparative modelling of dengue vaccine public health impact: Report to the World Health Organisation , 2016 .

[4]  A. Wilder-Smith,et al.  Points for Consideration for dengue vaccine introduction – recommendations by the Dengue Vaccine Initiative , 2016, Expert review of vaccines.

[5]  M. Hernández-Ávila,et al.  Análisis de la evidencia sobre eficacia y seguridad de la vacuna de dengue CYD-TDV y su potencial registro e implementación en el Programa de Vacunación Universal de México , 2016 .

[6]  B. Guy,et al.  Dengue vaccine: hypotheses to understand CYD-TDV-induced protection , 2015, Nature Reviews Microbiology.

[7]  Aurélia Nguyen,et al.  Meeting of the Strategic Advisory Group of Experts on immunization, April 2016 – conclusions and recommendations. , 2016, Releve epidemiologique hebdomadaire.

[8]  Thomas J. Hladish,et al.  Comparative modelling of dengue vaccine public health impact ( CMDVI ) 17 / 03 / 2016 Authors , 2016 .

[9]  Rana F. Hamdy,et al.  Efficacy of a Tetravalent Dengue Vaccine in Children in Latin America. , 2015, Journal of the Pediatric Infectious Diseases Society.

[10]  C. Simmons A Candidate Dengue Vaccine Walks a Tightrope. , 2015, The New England journal of medicine.

[11]  Nicholas Jackson,et al.  Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease. , 2015, The New England journal of medicine.

[12]  D. Cummings,et al.  Differential efficacy of dengue vaccine by immune status , 2015, The Lancet.

[13]  N. Turner Meeting of the Strategic Advisory Group of Experts on immunization, April 2015: conclusions and recommendations. , 2015, Releve epidemiologique hebdomadaire.

[14]  Stephen J. Thomas Preventing dengue--is the possibility now a reality? , 2015, The New England journal of medicine.

[15]  G. Carrasquilla,et al.  Efficacy of a tetravalent dengue vaccine in children in Latin America. , 2015, The New England journal of medicine.

[16]  D. Wood,et al.  Twenty-five years of the WHO vaccines prequalification programme (1987–2012): Lessons learned and future perspectives☆ , 2015, Vaccine.

[17]  H. Lopez-Gatell,et al.  Dengue in Latin America: A Persistent and Growing Public Health Challenge , 2015 .

[18]  Addendum to report of the Global Advisory Committee on Vaccine Safety (GACVS), 10-11 June 2015¹. Safety of CYD-TDV dengue vaccine. , 2015, Releve epidemiologique hebdomadaire.

[19]  A. Thompson,et al.  Ethical considerations in post-market-approval monitoring and regulation of vaccines. , 2014, Vaccine.

[20]  P. Pitisuttithum,et al.  Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial , 2014, The Lancet.

[21]  A. Wilder-Smith Dengue vaccines: dawning at last? , 2014, The Lancet.

[22]  T. Endy Human Immune Responses to Dengue Virus Infection: Lessons Learned from Prospective Cohort Studies , 2014, Front. Immunol..

[23]  J. Farrar,et al.  Long-term safety assessment of live attenuated tetravalent dengue vaccines: Deliberations from a WHO technical consultation , 2013, Vaccine.

[24]  S. Halstead,et al.  Secondary infection as a risk factor for dengue hemorrhagic fever/dengue shock syndrome: an historical perspective and role of antibody-dependent enhancement of infection , 2013, Archives of Virology.

[25]  Benjamin Djulbegovic,et al.  From efficacy to effectiveness in the face of uncertainty: indication creep and prevention creep. , 2011, JAMA.

[26]  Meeting of the Strategic Advisory Group of Experts on immunization, October 2009--Conclusions and recommendations. , 2010, Biologicals : journal of the International Association of Biological Standardization.

[27]  H. Meserve,et al.  Twenty-five years , 1986, Journal of Religion and Health.

[28]  C. Dolea,et al.  World Health Organization , 1949, International Organization.