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The US Food and Drug Administration has approved the first dengue fever vaccine, dengvaxie, but has imposed significant restrictions on its use, as it has been shown that the vaccine poses an increased risk for some people to contract a serious form of dengue fever. disease.
By eliminating the vaccine, the agency has recognized the important public health benefits of slowing a disease that affects hundreds of millions of people around the world. The decision can also help a product in difficulty whose use is blocked due to concerns about its potential risks.
"This shows the world that if it is used properly, the vaccine can be effective," said Duane Gubler, professor emeritus of the Duke-NUS Medical School, one of the inventors of the competing vaccine against dengue manufactured by Takeda, who consulted the past for Sanofi, which manufactures Dengvaxia.
Sanofi has sold Dengvaxia overseas since 2015, but the vaccine faced a major hurdle in 2017 after the Philippines, which had widely distributed the product to schoolchildren, ceased use and revoked Sanofi's license.
This decision was made after Sanofi announced that, in rare cases, if people who had never contracted dengue fever were vaccinated and subsequently infected, the vaccine could cause a much more serious form of illness. On May 1, the FDA restricted its authorization to people aged 9 to 16 living in endemic areas and where laboratory tests have already shown an infection with the disease.
According to the Center for Disease Control and Prevention, more than a third of the world's population lives in areas at risk of dengue virus infection. The virus is transmitted by mosquitoes.
An estimated 400 million dengue infections worldwide and about 5,000,000 severe cases of the severe form, dengue hemorrhagic fever, which causes about 20,000 deaths, according to the CDC.
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By eliminating the vaccine, the agency has recognized the important public health benefits of slowing a disease that affects hundreds of millions of people around the world. The decision can also help a product in difficulty whose use is blocked due to concerns about its potential risks.
"This shows the world that if it is used properly, the vaccine can be effective," said Duane Gubler, professor emeritus of the Duke-NUS Medical School, one of the inventors of the competing vaccine against dengue manufactured by Takeda, who consulted the past for Sanofi, which manufactures Dengvaxia.
Sanofi has sold Dengvaxia overseas since 2015, but the vaccine faced a major hurdle in 2017 after the Philippines, which had widely distributed the product to schoolchildren, ceased use and revoked Sanofi's license.
This decision was made after Sanofi announced that, in rare cases, if people who had never contracted dengue fever were vaccinated and subsequently infected, the vaccine could cause a much more serious form of illness. On May 1, the FDA restricted its authorization to people aged 9 to 16 living in endemic areas and where laboratory tests have already shown an infection with the disease.
According to the Center for Disease Control and Prevention, more than a third of the world's population lives in areas at risk of dengue virus infection. The virus is transmitted by mosquitoes.
An estimated 400 million dengue infections worldwide and about 5,000,000 severe cases of the severe form, dengue hemorrhagic fever, which causes about 20,000 deaths, according to the CDC.
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