Considering the potential severity of the condition, the good benefit-risk profile of DENGVAXIA®, the lack of alternatives available, the place of DENGVAXIA® in the therapeutic strategy, and the unlikely impact of DENGVAXIA® on public health, the committee considered the actual benefit of DENGVAXIA® to be ‘weak’ in the indication of the Marketing Authorisation. Furthermore, given the demonstrated clinical efficacy of DENGVAXIA®, the increased risk of virologically confirmed dengue fever, and the lack of a robust and validated diagnostic test for previous infection, the committee considered that DENGVAXIA® provides no improvement in actual benefit (ASMR V) in this indication. It was concluded that the target population for DENGVAXIA® is estimated to be between 296,000 and 406,000 people.