Sanofi's dengue vaccine Dengvaxia has been approved by the European Commission to prevent the virus infection in individuals who have previously been infected.
The French pharmaceutical giant, which spent two decades developing the world's first dengue vaccine, said Dengvaxia is used to prevent dengue fever in people aged nine to 45 years.
The approval follows the decision of the European Medicines Agency, which recommended the use of the vaccine to prevent fever caused by dengue virus serotypes 1, 2, 3 and 4 in the EU.
Dengue fever is a mosquito-borne infection that people can get up to four times in a lifetime. The disease is endemic in several European territories located in tropical and subtropical climates prone to outbreaks, especially during the rainy season.
Dengvaxia came under scrutiny in 2017 when Sanofi said the vaccine should not be recommended for people who have not previously been infected by the virus, as severe cases of the disease can occur in these people who contract dengue after vaccination. Sanofi, however, stood by the medicine and said it offered "strong and persistent" protection in people aged nine and above. An advisory panel of the World Health Organization also backed the use of Dengvaxia but only after individuals have been tested for previous exposure to the virus.
Sanofi said in a Dec. 19 press release that the vaccine has been evaluated in studies involving more than 40,000 people from 15 countries with up to six years of follow-up data on safety and efficacy.
Sanofi is also developing a diagnostic test, which is expected to be ready in the second half of 2020, to facilitate broader use of the dengue vaccine. Dengvaxia is under priority review by the U.S. Food and Drug Administration and a decision is expected by May 1, 2019.