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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.
Sanofi Pasteur, the vaccines division of Sanofi, announced on Dec. 9, 2015 that Mexican authorities have granted marketing authorization to Dengvaxia, the first vaccine to be licensed for the prevention of dengue fever.
According to the World Health Organization (WHO), dengue is a mosquito-borne viral infection that causes flu-like symptoms. The infection is prevalent in tropical climates, and is a leading cause of illness and death for children in Latin American and Asian countries. The WHO has set a goal for epidemic countries to decrease mortality rate by 50% for 2020.
The Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) approved the vaccine for use in adolescents and adults, 9–45 years of age. According to the company, the approval was based on results from a clinical development program with 40,000 people from 15 different countries. Participants were a variety of ages and from an array of geographic, ethnic, epidemiological, and socio-economic backgrounds. The first doses of the drug are currently being produced in France.
According to a report from New York Times, it is still unclear how the vaccine will be deployed in Mexico, as a result of national budget restraints. There may also be some limits to the vaccine’s effectiveness. Clinical trials showed it to reduce the risk of developing the illness by 60%. According to the publication, some experts say this rate is less effective than desired.
While the vaccine is expected to be available in Mexico early next year, it is still being reviewed for approval in other epidemic countries. Oliver Charmeil, executive vice-president at Sanofi, said that the company will apply for approval for the vaccine in 20 Latin American and Asian countries.