Sanofi gets US approval to sell dengue vaccine, but with significant restrictions

CHICAGO – The US Food and Drug Administration on Wednesday gave a very close endorsement to Sanofi SA's dengue vaccine, Dengvaxia, which still suffers evidence that its vaccine, which has taken 20 years to develop, can cause severe infections in some people.

According to the FDA, the drug can only be administered to people aged 9 to 16 years who have a laboratory confirmation of a previous dengue infection and live in areas where the disease is prevalent, such as Puerto Rico, the US Virgin Islands and American Samoa.

Sanofi had asked for a much wider endorsement including people aged 9 to 45, but an FDA advisory committee in March recommended reducing the age range, excluding its use in adults.

Sanofi revealed in late 2017 that dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, which triggered a government investigation in the Philippines, where 800,000 children of age to attend school had already been vaccinated.

In March, the Philippine Justice Ministry said it had found a likely cause to charge officials of Sanofi and former health officials in the Philippines, causing more than 10 deaths, allegedly linked to Dengue vaccine. Sanofi said that he totally disagreed with these results.

The FDA has clarified that dengvaxis is not approved for people who have never been infected with any of the four types of viruses transmitted by mosquitoes. (Bit.ly/2IQav7S)

Dengue fever is the fastest growing infectious disease in the world and affects hundreds of millions of people around the world. It causes half a million life-threatening infections and kills around 20,000 people, mostly children, every year.

After reviewing security risks, the World Health Organization announced last spring that the Sanofi vaccine should only be used in people already exposed to dengue, which would significantly reduce the potential market for dengvaxia. , the world 's first vaccine against dengue, considered a potential billion – dollar product of the year.

In December, Dengvaxia was approved in Europe for people aged 9 to 45 living in endemic areas with documented previous infection.

"FDA approval of dengvaxia now allows us to provide a critical medical prevention tool for at-risk populations, helping to combat and prevent dengue fever, especially among children, in the general population. Dengue endemic areas in the United States, "said Dr. David Greenberg, Sanofi's regional medical officer for North America. said in a statement.