Dengvaxia Dengue Vaccine Endorsed by EU Committee

Sanofi Dengvaxia dengue vaccine seeks marketing approval in Europe

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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted on October 19, 2018, a positive opinion for the marketing authorization of Sanofi's dengue vaccine Dengvaxia. 

This means CHMP is recommending Dengvaxia approval in Europe, which is expected during 2018. 

Dengvaxia is currently licensed in 20 countries for the prevention of dengue, but not in the USA. 

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The indication for the Dengvaxia vaccine recommended by the CHMP is for use in the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 to 45 years of age, with prior dengue virus infection and living in endemic areas. 

A person can get dengue more than once as there are 4 distinct virus serotypes. 

During December 2017, Sanofi said in a press release, ‘As previously communicated, Sanofi Pasteur proposed a label update to regulatory authorities for the Dengvaxia dengue vaccine based on new analysis showing that the vaccine performance differs according to prior dengue infection status.’ 

‘Sanofi Pasteur is proposing a label update that asks healthcare professionals to assess the likelihood of prior dengue infection in an individual before vaccinating. Vaccination should only be recommended when the potential benefits outweigh the potential risks.’ 

‘For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.’ 

Dengue infection is unique in that a secondary infection tends to be worse than the first infection. 

Therefore, preventing dengue in individuals with a prior dengue infection has the potential to reduce the high human and economic costs of severe dengue. 

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"This is good news for people living in dengue-endemic parts of the European territories where frequent outbreaks could put them at risk of re-infection with another dengue virus serotype, which is often more severe than the first infection," said Su-Peing Ng, Global Medical Head at Sanofi Pasteur, in a press release.  

Dengue fever is a debilitating disease typically leading to prolonged fever and severe joint pain. 

Dengue infection can progress unpredictably to a life-threatening form of the disease called dengue haemorrhagic fever, says the US Centers for Disease Control and Prevention (CDC).

Moreover, there is no specific treatment available for dengue disease. 

According to the CDC, half of the world's population living in 128 countries is at risk of dengue. 

The dengue vaccine has been evaluated in studies involving more than 40,000 people from 15 countries with up to 6 years of follow-up data from large-scale clinical safety and efficacy investigations. 

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Currently, there is another dengue vaccine candidate in Phase 3 clinical trial, Takeda’s TAK-003.

Vaccines for international travelers are available at certified pharmacies in the USA. 

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Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the FDA or CDC.