The Mexican drug authorities have approved Sanofi Pasteur’s first ever dengue vaccine Dengaxia, which promises to reduce the disease burden by 50 percent in five years among vulnerable populations.
“The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved Dengaxia, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults, 9 to 45 years of age living in endemic areas,” said Sanofi Pasteur in a press statement.
The French vaccine maker has applied for regulatory approval in countries where the disease is endemic, however it did not specify the countries where it has applied for a marketing license. India though has participated in the trial which showed that dengue vaccine after three doses was well tolerated and produced antibodies against all four dengue serotypes.
“There were no cases of severe dengue reported, no deaths and no related serious adverse events reported during the trial. The Sanofi Pasteur dengue vaccine candidate is a live attenuated, recombinant tetravalent vaccine with a vaccination schedule of 3 doses, given 6 months apart (at 0, 6 and 12 months). The vaccine has been found to be well tolerated in the study population.” said Dr Sharad Agarkhedhar, of D Y Patil Hospital, Pune who was the principal investigator for phase 2 clinical study of the vaccine in five Indian cities of Delhi, Ludhiana, Kolkata, Pune and Bengaluru.
The approval from Mexican authorities, Sanofi said is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries.”
The World Health Organisation has called on endemic countries to reduce dengue mortality by 50% and morbidity by 25% by 2020. Statistics from WHO show that dengue is the fastest growing mosquito borne disease in the world causing 400 million infections every year.
Source: The Economic Times