- •The possibility that dengue vaccines can cause severe dengue has led to serious concern regarding the safety of mass vaccination programs.
- •This paper points out problems in the analyses of a published meta-analysis addressing this safety issue for a new vaccine against dengue fever—Dengvaxia.
- •Although the authors of the meta-analysis show a sevenfold rise in hospitalization for dengue fever in children <5 years old, they fail to point out two signals of harm for another outcome—hospitalization for severe dengue fever in children younger than 9 years, the relative risk was 8.5 (95% confidence interval [CI]: 0.5, 146.8), and in the overall study group, the relative risk was 5.5 (95% CI: 0.9, 33).
- •The selective reporting and inappropriate subgroup claims mask the potential harm of dengue mass vaccination programs.
- •Countries planning public use of the vaccine must conduct diligent postmarketing surveillance, secure informed consent from parents of potential recipients, and closely monitor the results of ongoing long-term follow-up of clinical trial participants.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- Efficacy and long-term safety of a dengue vaccine in regions of endemic disease.N Engl J Med. 2015; 373: 1195-1206
- Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.Lancet. 2014; 384: 1358-1365
- Efficacy of a tetravalent dengue vaccine in children in Latin America.N Engl J Med. 2015; 372: 113-123
- Immune enhancement of viral infection.Prog Allergy. 1982; 31: 301-364
- The complexity of antibody-dependent enhancement of dengue virus infection.Viruses. 2010; 2: 2649-2662
- Epidemiologic programs for computers and calculators. Exact binomial confidence intervals for the relative risk in follow-up studies with sparsely stratified incidence density data.Am J Epidemiol. 1987; 125: 340-347
- Confidence intervals for weighted proportions.Stat Med. 1994; 13: 1071-1082
- Chapter 25.2 How to use a subgroup analysis. User’s Guides to the Medical Literature: A manual for evidence-based clinical practice.3rd ed. McGraw-Hill Education, USA2015: 515-527
- Addressing the vaccine confidence gap.Lancet. 2011; 378: 526-535
Conflict of interest: None.