Dengvaxia Adverse Reactions

Data in subjects 9 years of age or older: Summary of the safety profile: A total of approximately 20,667 subjects 9 through 60 years of age received at least one injection of the final formulation of Dengvaxia according to the claimed vaccination schedule in 13 randomized, observer-blinded, placebo-controlled Phase II to Phase III clinical studies.
The safety profile was assessed in a total of 1547 subjects 18 through 60 years of age and 19,120 subjects 9 through 17 years of age. To support the indication, the safety profile presented as follows is focused on the pooled analysis of safety data in children and adolescents from 9 years of age, i.e. subjects 9 through 17 years of age. Reactogenicity was assessed in a subset of 3068 out of those 19,120 subjects.
Safety was monitored during the first 28 days following each injection in the reactogenicity subset, and serious adverse event (SAEs), including dengue cases, were collected throughout the studies in all subjects, up to at least 6 months after the last injection of the vaccine.
In subjects 9 through 17 years of age, the most frequently reported ARs following any injection of the vaccine were headache, injection site pain, malaise and myalgia.
The ARs were usually mild to moderate in severity and of short duration (0 to 3 days). Onset was typically observed 0 to 3 days after the injection, except for fever which appeared within 14 days after the injection.
Systemic ARs tended to be less frequent after the second and third injections as compared to the first injection.
Tabulated list of adverse reactions: Adverse reactions are listed according to the following frequency categories: Very common: ≥ 1/10 (≥ 10%), Common: ≥ 1/100 to < 1/10 (≥ 1% and < 10%), Uncommon: ≥ 1/1000 to < 1/100 (≥ 0.1% and < 1%), Rare: ≥ 1/10,000 to < 1/1000 (≥ 0.01% and < 0.1%), Very Rare: <1/10,000 (≥ 0.01%).
ARs within 28 days after any injection in subjects 9 through 17 years of age are presented in Table 4, based on safety data collected during clinical studies. (See Table 4.)


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Hospitalized and/or clinically severe dengue fever in long-term safety follow-up data: In an exploratory analysis of up to 6 years of follow up from the first injection in three efficacy studies, an increased risk of hospitalization for dengue including clinically severe dengue (predominantly Dengue Hemorrhagic Fever grade 1 or 2 [WHO 1997]) has been observed in vaccinees with no previous dengue infection. In subjects 9 years of age or older, it was estimated that during a 5 year follow-up about 5 additional hospitalized dengue cases or 2 additional severe dengue cases per 1000 vaccinees with no previous dengue infection could occur following vaccination. Estimates from the long-term analysis suggest the onset of increased risk was mainly during the 3^rd year following the first injection.
This increased risk was not observed in individuals who have been previously infected by dengue virus, where it was estimated that 15 hospitalized dengue cases or 4 severe dengue cases could be prevented per 1000 vaccinees with previous dengue infection during 5 years of follow up from the first injection.