Sanofi announced Wednesday that it plans to ask regulatory authorities, in countries where Dengvaxia is approved, to limit the use of the dengue vaccine to people who were previously infected by the virus. The drugmaker noted that the decision was based on an analysis demonstrating significant differences in vaccine performance according to prior dengue infection. Su-Peing Ng, global medical head at Sanofi's Pasteur division, remarked "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."
Sanofi said it analysed the long-term safety and efficacy of Dengvaxia based on as much as six years of clinical data. The drugmaker found that Dengvaxia was persistently protective in patients who had been previously infected by the dengue virus. Conversely, for individuals not previously infected by the virus, the company stated that in the longer term, more cases of severe disease were possible after immunisation upon a subsequent dengue infection.
Sanofi indicated it will be taking a charge of 100 million euros ($119 million) in the fourth quarter based on the expected effects of the decision on future vaccine sales. Analysts currently forecast Dengvaxia sales of 360 million euros ($427 million) by 2022. However, the company indicated that it does not expect the move to affect its prior earnings guidance for the full year.
Dengvaxia was initially approved in 2015 in Mexico as the world's first dengue vaccine to gain regulatory clearance. The World Health Organization's Strategic Advisory Group of Experts on Immunization later backed use of the vaccine in countries with high dengue transmission. Analyst had estimated that the vaccine could achieve more than $1 billion in annual sales.
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