DENGVAXIA (dengue quadrivalent vaccine (live, attenuated))

Key points

Favourable opinion for reimbursement in the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with previous dengue infection, living in endemic regions and only in the populations recommended by the current vaccine strategy.

The Committee considers that access to an effective and validated diagnostic test to confirm previous dengue infection is essential.

What therapeutic improvement?

No clinical added value in the prevention of symptomatic virologically-confirmed dengue infections.

Role in the care pathway?

In its vaccine recommendations published in 2019, the HAS does not recommend the use of DENGVAXIA (Dengue quadrivalent vaccine [live, attenuated]):

• For individuals living in or travelling to Reunion island;
• For individuals living in French territories in America (except for those providing documented evidence of confirmed infection);
• For individuals travelling to French territories in America;
• For individuals living in or travelling to Mayotte.

The HAS considers that vaccination with the DENGVAXIA vaccine may be offered to individuals living in French territories in America and providing documented evidence of previous virologically-confirmed dengue virus infection.

This HAS position may be revised in the future, firstly in the event of a resumption of active circulation of dengue disease in French territories in America or depending on the evolution of the epidemiology of dengue disease on Reunion Island and in Mayotte, and secondly, if a test, whose performance for the assessment of past dengue infection is validated by an independent evaluation, becomes available .

The HAS recommends the conduct of a study assessing the seroprevalence in children aged 9 to 18 years in the French Caribbean region.

Role of the medicinal product in the care pathway

The Transparency Committee considers that DENGVAXIA dengue quadrivalent vaccine (live, attenuated) must be used in accordance with its MA and following current vaccine recommendations. It should be used in the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age with previous dengue infection, living in endemic regions. The Committee considers that, for this use, access to an effective and validated diagnostic test to confirm previous dengue infection is essential.

It highlights that the conditions of use of this vaccine are not optimal due to the current absence of a robust and validated test to diagnose previous dengue virus infection and the additional risk of virologically-confirmed dengue disease leading to hospitalisation or severe virologically-confirmed dengue disease if a seronegative individual is vaccinated (false positive).

Special recommendations

The Transparency Committee supports the request formulated in the HAS vaccine recommendations of January and March 2019 to conduct a study assessing the seroprevalence in children aged 9 to 18 years in the French Caribbean region.

In addition, it highlights that it will re-evaluate this opinion if the vaccine recommendations relative to the dengue disease control strategy, particularly in French overseas regions, are revised, and within a maximum period of 2 years.