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The 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 used correctly, 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 the dengue manufactured by Takeda. passed 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, stopped its 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.
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.
The disease, also known as bone fever, can be excruciating, with high fever, headache, muscle and joint pain, and persistent weakness. A second dengue infection can lead to a severe form of the disease, which can cause bleeding or shock and can be fatal.
An estimated 400 million dengue infections worldwide and about 500,000 cases of severe form, dengue hemorrhagic fever, which causes about 20,000 deaths, according to the C.D.C. No drugs are approved to treat dengue.
According to the C.D.C., most cases of dengue in the 48 contiguous states were acquired elsewhere by travelers or immigrants, although isolated epidemics occurred, such as in southern Texas in 2005. Dengue is endemic in the territories of American Samoa, Guam, Puerto Rico and the Virgin Islands in the USA.
"I think the message is that it's such a serious disease that we need something," said Vincent Racaniello, professor of microbiology and immunology at Columbia University.
He is concerned that the risks identified by the vaccine may exacerbate a more general, unfounded skepticism about vaccines, fueling a distinct global measles epidemic. "It will give them more ammunition," he said. "They can take that and say look, we are releasing a vaccine that is known to have problems."
In the Philippines, childhood measles immunizations have followed the tumult of dengvaxia, contributing to an epidemic in the country, which has killed more than 400 people since January, according to a report released this week by Unicef and UNICEF. World Health Organization.
Although dengvaxia is currently the only dengue vaccine on the market, other vaccines are under development. They would be more effective and could be used by people who have never had dengue fever. These include Takeda in advanced clinical trials and one that Merck plans to commercialize.
"It's a pretty big pipeline for dengue fever," said Dr. Racaniello.
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