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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted on 19 October 2018 a favorable opinion on the marketing authorization of the Sanofi Dengvaxia dengue vaccine.
This means that the CHMP recommends the approval of Dengvaxia in Europe, which is scheduled for 2018.
Dengvaxia is currently authorized in 20 countries for the prevention of dengue, but not in the United States.
The CHMP recommended dengvaxis vaccine indication is intended for use in the prevention of dengue fever caused by serotypes 1, 2, 3 and 4 of the dengue virus in persons aged 9 to 45 years , previously infected with the dengue virus and living in endemic areas. .
A person can contract dengue fever more than once because there are 4 different virus serotypes.
In December 2017, Sanofi said in a press release: "As previously stated, Sanofi Pasteur has proposed to the regulatory authorities to update the label of dengue vaccines against dengvaxia, based on the following: a new analysis showing that the performance of the vaccine differs according to the previous status of dengue infection. "
"Sanofi Pasteur is proposing a label update asking health professionals to assess the likelihood of prior dengue infection in an individual prior to vaccination. Vaccination should only be recommended when the potential benefits outweigh the potential risks. "
"Vaccination should not be recommended for people who have never been previously infected with dengue fever."
Dengue infection is unique in that a secondary infection tends to be worse than the first infection.
Therefore, preventing dengue fever in people who have already contracted dengue fever could reduce the high human and economic costs of dengue fever.
"This is good news for people living in areas of European countries where dengue is endemic and where frequent outbreaks could expose them to a risk of reinfection with another serotype of the dengue virus, which is often more serious than the first infection, "said Su-Peing. Ng, global medical manager at Sanofi Pasteur, in a press release.
Dengue fever is a debilitating disease usually resulting in prolonged fever and severe joint pain.
Dengue infection can be an unpredictable form of death-threatening life-threatening dengue haemorrhagic fever, according to the US Centers for Disease Control and Prevention (CDC).
In addition, there is no specific treatment available for dengue fever.
According to the CDC, half of the world's population living in 128 countries is at risk of dengue fever.
The dengue vaccine was evaluated in studies involving more than 40,000 people in 15 countries and up to 6 years of follow-up data from large-scale safety and health investigations. clinical efficacy.
Recent news on the dengue vaccine:
Currently, there is another dengue vaccine candidate in phase 3 of the clinical trial, Takeda's TAK-003.
* Clinical trial on chronic kidney disease, click here *
Vaccines for international travelers are available at certified pharmacies in the United States.
** Make an appointment for a vaccine **
Vaccines, like any medicine, can have side effects. We encourage you to report adverse reactions to vaccines to the FDA or CDC.
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