US FDA Approves First Vaccine For Dengue, But Limits Its Use

Maryland, 5 May 2019: The US Food and Drug Administration has approved the first vaccine for dengue, Dengvaxia, but placed significant restrictions on its use because the vaccine has been shown to put some people at heightened risk for a severe form of the disease.

In clearing the vaccine, the agency acknowledged the serious public health benefit of slowing a disease that affects hundreds of millions of people around the world. The decision may also help a struggling product whose use has stalled because of concerns over its possible risks.

"It tells the world that if properly used, the vaccine can be effective," said Duane Gubler, an emeritus professor at Duke-NUS Medical School who is one of the inventors of a competing dengue vaccine made by Takeda, and has consulted in the past for Sanofi, which makes Dengvaxia.

Sanofi has sold Dengvaxia overseas since 2015, but the vaccine hit a major roadblock in 2017 after the Philippines, which had widely distributed the product to schoolchildren, halted its use and revoked Sanofi's licence.

That decision came after Sanofi announced that in rare cases, if people who never had dengue were vaccinated and later became infected, the vaccine might provoke a much more severe form of the illness. On May 1, the FDA limited its approval to people aged 9 to 16 who live in areas where dengue is endemic and who are shown by lab testing already to have been infected with the disease.

More than one-third of the world's population lives in areas at risk for infection with the dengue virus, according to the Centers for Disease Control and Prevention. The virus is spread by mosquitoes.

As estimated 400 million dengue virus infections occur around the world, and there are about 5,00,000 severe cases of the severe form, dengue haemorrhagic fever, which causes about 20,000 deaths, according to the CDC.

FDA NEWS RELEASE The Times Of India