Sanofi requests health authorities update information on Dengvaxia, based on new data

Sanofi is requesting that health authorities update information on its dengue vaccine Dengvaxia, as a result of a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.

The new clinical data, which has been collected over a period of six years, evaluated the long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not. The analysis confirmed that the vaccine provided persistent protection against dengue fever in those who had prior infection, but in infection-naïve patients it was found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.

“These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries,” said Dr Su-Peing Ng, global medical head, Sanofi Pasteur.

Proposed Label Update

Based on the new analysis, Sanofi will propose that national regulatory agencies update the prescribing information, known as the label in many countries, requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.

The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration. Following their review, each agency might amend the company proposed label.