Dengue vaccine development and safety: What went wrong?


Authors: Barry A Eagel, Anthony La, Deepak Kumar Palanichami, Gerard St Cyr, Lauren Orlando, Abidemi Fasanmi, and Emmanuel Keku
Page Range: 101-115
Published in: International Public Health Journal, 15#1 (2023)
ISSN: 1947-4989

Table of Contents


Dengue infection is caused by the bite of an infected mosquito carrying one of four dengue virus variants. In 2015, the first vaccine for dengue fever, Dengvaxia® (Sanofi-Pasteur) was approved. Its indication was limited to prior dengue fever infections to prevent severe dengue, due to serious adverse effects seen during the Phase 3 trials with dengue seronegative subjects. The reasons for those serious adverse events were evaluated by a focused literature review. Literature searches of five databases identified clinical studies and reviews that were relevant to the drug approval, safety, and efficacy of dengue vaccines, and found a total of 830 articles, of which there were 25 clinical trials of dengue vaccines. Review of the clinical trials and subsequent safety analyses showed that either transmission of dengue virus through a mosquito bite or immunization may create partial immunity to some dengue subtypes, and non-neutralizing antibodies formed may facilitate viral replication, increasing the likelihood of severe dengue sequelae. The limits of the current approved vaccine and alternatives will be reviewed. Increased morbidity and mortality were due to antibody-dependent enhancement caused by the vaccine. Individual testing for dengue antibodies before vaccination is safer than reliance on population seroprevalence rates.

Keywords: Dengue, dengue fever, dengue vaccine, antibody-dependent enhancement, epidemiology, clinical trial, pharmacovigilance, post-marketing safety surveillance

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