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The EU Medicines Agency requests approval for dengue vaccine

LONDON – Europe's drug regulator has recommended to approve the first vaccine for dengue despite concerns about the wide use…

LONDON – Europe’s drug regulator has recommended to approve the first vaccine for dengue despite concerns about the wide use of the vaccine and a trial in the Philippines claiming that it was linked to three deaths.

The European Medicines Agency announced Friday that it had adopted a “positive opinion” by the French drug company Sanofi’s Dengvaxia. The vaccine is the world’s first against dengue, which causes around 96 million people annually.

The mosquito-virus is found in tropical and subtropical climates across Latin and South America, Asia, Africa and elsewhere. It causes a flu-like disease that can cause joint pain, nausea, vomiting and rashes. In severe cases, dengue may lead to difficulty breathing, bleeding and organ failure.

There is no specific treatment for dengue and there are no other licensed vaccines on the market.

Earlier this year, the World Health Organization said the vaccine had to be managed “in a much safer way” and should be given mainly to people who previously had dengue. The vaccine is licensed for use in about 20 countries.

The United Nations Health Authority said there were “significant barriers” when using the vaccine and that a rapid test would be developed to determine if people had previously been infected with dengue. [1

9659007] Sanofi probably warned that people who had never been sickened by dengue were at risk of more serious disease after receiving the vaccine. The company said it is expected to incur a loss of 100 million euros (118 million USD) based on the current news.

The Philippines was the first country to introduce a national dengue immunization program – which was stopped after Sanofi’s announcement last year. The government also demanded repayment of more than 3 billion pesos (59 million USD) from Sanofi. In February, the Philippines said the vaccine was potentially linked to the death of three people: all were killed by dengue, despite being immunized against it.

The country imposed a symbolic fine of $ 2,000 on Sanofi and resigned from the vaccine’s approval, charge as drugmaker broke rules on how the shot was registered and marketed.

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