The US Food and Drug Administration on Wednesday gave Sanofi SA’s dengue vaccine Dengvaxia a very narrow approval as the company continues to suffer from evidence that its vaccine, which took 20 years to develop, can cause severe infections in some people.
Sanofi had sought a much broader approval that would have included people aged nine to 45 years, but an FDA advisory panel in March recommended the narrower age range, excluding its use in adults. In March, the Philippine Justice Department said it found probable cause to indict Sanofi officials and former Philippine health officials over 10 deaths it said were linked to the dengue vaccine. Sanofi has said it strongly disagrees with those findings.for individuals who have not previously been infected by one of the four types of the virus, which is spread by mosquitoes.
After reviewing the safety risks, the World Health Organisation last spring said Sanofi’s vaccine should only be used on individuals with proven prior dengue exposure, significantly reducing the potential market for Dengvaxia, the world’s first dengue vaccine which had been seen as a potential US$1 billion a year product.
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US approves dengue vaccine Dengvaxia | The Malaysian InsightUS health authorities have given their approval to dengue vaccine Dengvaxia, the controversial first treatment designed to protect against the deadly mosquito-borne virus.\n\nThe Food and Drug Administration made the announcement on Wednesday.\u00a0\n\nThe vaccine can used only under certain strict conditions: only children aged between nine and 16, who have previously confirmed infections, and who live in endemic areas, may receive the dose.\n\n\u201cWhile there is no cure for dengue disease\u2026 approval is an important step toward helping to reduce the impact of this virus,\u201d said Anna Abram, a senior FDA official.\n\nThe virus is endemic in the US territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands, said the FDA.\n\nDengue, which causes hemorrhagic fever, is the world's most common mosquito-borne virus and infects an estimated 390 million people in more than 120 countries each year \u2013 killing more than 25,000 of them, according to the World Health Organisation.\n\nBut Dengvaxia, produced by the French pharmaceutical firm Sanofi Pasteur, is controversial: the Philippines, which became the first country to approve it in 2016, was also the first to ban it in February this year over safety concerns.\n\nManila is also pursuing criminal charges against the company officials over the deaths of children injected with Dengvaxia.\n\nSanofi denies the charges but in 2017 admitted the vaccine was not suitable for people who had not previously been infected with the virus.\n\nDengvaxia has previously been approved in 19 countries and the European Union, which greenlit the vaccine under similar conditions to the US, though the age range was nine to 45-years-old. \u2013 AFP, May 2, 2019.
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