New Delhi/Paris: Sanofi will ask health authorities to update information provided to physicians and patients on its dengue vaccine, ‘Dengvaxia’ in countries where it is approved. The request is based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection.
Based on up to six years of clinical data, the new analysis evaluated 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 Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection. For those not previously infected by dengue virus, however, the analysis 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.
India is yet to approve the Sanofi’s Dengvaxia due to what the top health authorities have called the lack of enough indigenous data and especially the few adverse reactions reported during trials on children. While the need for a dengue vaccine has been felt most in the recent times due to spurt in the incidents of deaths due to it, the new findings just seem to vindicate the reasons for delayed decision by the Indian officials.