Dengvaxia Coming to the USA
Dengue virus vaccine Dengvaxia receives FDA Priority Review
The first and only vaccine against the dengue virus, Dengvaxia, has been granted the United States Food and Drug Administration (FDA) Priority Review status.
The FDA has set a Prescription Drug User Fee Act action date of May 1, 2019.
Sanofi Pasteur's dengue vaccine candidate is considered an unmet medical need by the FDA.
Dengue virus is endemic in the US territories of Puerto Rico and the US Virgin Islands.
People can get dengue up to 4 times and dengue is unique in that the 2nd infection tends to be worse than the first.
This means that prevention of re-infection with another dengue serotype can help to reduce the individual risk of severe dengue, as well as the overall health care costs associated with hospitalization due to dengue.
Dr. David Greenberg, Regional Medical Head North America, Sanofi Pasteur, said in a press release, "The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to 6 years of follow-up data from large-scale investigations."
Previously, the European Commission is expected to grant marketing authorization for Dengvaxia in December 2018.
Dengvaxia is currently licensed in 20 countries for the prevention of dengue.
Moreover, half of the world's population living in 128 countries is at risk of dengue.
During December 2017, Sanofi said in a press release, ‘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.’
The CDC has issued various travel alerts related to dengue.
On October 3, 2018, the CDC issued a Travel Alert for Chiapas Mexico, where 1,350 dengue cases have been confirmed during 2018.
Vaccines for international travelers are available at certified pharmacies in the USA.
Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the FDA or CDC.