The committee of the European Medicines Agency has issued a favorable opinion for the marketing of Dengvaxia, a vaccine manufactured by Sanofi to protect against the dengue virus.
Friday, October 19, the French pharmaceutical company Sanofi made public the decision of the European Medicines Agency (EMA), which gave the green light for the marketing of Dengvaxia, a preventive vaccine against the dengue virus. Transmitted by mosquitoes, this disease wreaks havoc in tropical regions, particularly in several French overseas territories, such as the West Indies, French Polynesia and Reunion Island.
In accordance with the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA, the administration of Dengvaxia is recommended for people aged 9 to 45 years who have already been infected with the virus and live in areas of endemic. “Marketing authorization from the European Commission is expected in December 2018,” Sanofi said.
Health scandal in the Philippines
Dengvaxia is currently already authorized in around twenty countries affected by the Dengue fever epidemic, such as Brazil, Mexico and the Philippines. The world’s first vaccine to prevent dengue, Sanofi’s product found itself at the heart of a health scandal in 2017.
Last February, the Philippine government established a link between three recent deaths and the dengue fever vaccine from the French laboratory Sanofi. At the end of November, the laboratory had published a press release mentioning performance discrepancies about its Dengvaxia vaccine and recognized that it could present risks for people who have never before suffered from the disease. The Philippines had then suspended its national vaccination campaign, but 733,000 children had had time to receive the vaccine.
50 million cases of Dengue per year
Two months later (April 2018), the World Health Organization looked into Dengvaxia. The United Nations agency has recommended testing each patient individually to ensure that they have not been exposed to the virus before.
According to Sanofi, the Dengvaxia vaccine has been evaluated “in the context of clinical studies that included more than 40,000 people in fifteen countries, supplemented by large-scale efficacy and tolerance studies offering up to six years of follow-up at this day”.
Also called “tropical flu”, dengue fever is a tropical hemorrhagic fever linked to an arbovirus, transmitted by a mosquito of the genus Aedes. The WHO estimates the number of annual cases worldwide at 50 million, including 500,000 cases of “haemorrhagic” dengue fever, which are fatal in more than 2.5% of cases.
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