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Message: <blockquote data-quote="netlife007" data-source="post: 22499737" data-attributes="member: 79514">“What is good in Singapore and 16 other countries is being unnecessarily questioned, opposed or delayed by Sri Lankan doctors and the Ministry of Health,” said one parent whose child was diagnosed with dengue. Among the other Asian countries where the vaccine is available are Malaysia, Indonesia and Thailand. The vaccine has been administered to over 800,000 people since it was released globally following the WHO in July last year issuing its recommendation that countries with a high dengue burden consider the introduction of the dengue vaccine to help better control the disease.Sanofi Pasteur is effective against all four dengue virus types (serotypes).In March 2017, the National Medicines Regulatory Authority had informed Sanofi Pasteur that it needs to assess post-marketing surveillance data from countries in which the vaccine has been used for a period of one year before making a decision on approval of the vaccine. A spokesperson for Sanofi Pasteur told Daily FT that the company responded to the queries of NMRA in a letter dated 4 April 2017 and provided long-term safety and efficacy data from clinical trials involving over 35,000 subjects and post-marketing safety surveillance. “Since then we have been closely engaged with the NMRA and await their decision on approval of the vaccine for use in Sri Lanka,” the spokesperson added.Sanofi Pasteur said it has long-term data on the safety of the vaccine for six years post-vaccination from a Phase IIB efficacy study (involving 4,002 subjects) and for five and four years respectively from two phase III studies conducted in 10 dengue-endemic countries of Asia and Latin America (involving over 31,000 subjects).</blockquote>

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