The first vaccine to prevent dengue fever has been approved for use in Mexico, the country’s drugs regulator has announced.
The decision by the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) was based on the results of more than 25 clinical trials conducted by vaccine manufacturer Sanofi Pasteur in 15 countries – including Mexico – which involved more than 40,000 volunteers.
Dengvaxia is a chimeric tetravalent vaccine for prevention of disease caused by all four dengue virus serotypes (l, ll, lll and lV) and is made from attenuated dengue. The product is authorised for use in populations where dengue is endemic.
COFEPRIS says the vaccine has an average efficacy of 60.5% for preventing infection and 93.2% efficacy for preventing severe dengue infection in patients aged 9–45 years.
The regulator estimates that the vaccine could help prevent 8,000 hospital admissions and 104 deaths every year from the virus in Mexico, saving 1,100 million pesos in healthcare costs. In 2014, Mexico recorded 32,100 cases of dengue fever.
JosÃ© Luis Arredondo GarcÃa, associate director of clinical research at the National Institute of Pediatrics in Mexico, says: “The first vaccine approved to prevent dengue fever is a major innovation and a public health breakthrough. Dengvaxia will be a critical addition to the integrated dengue prevention and control efforts.”
Manufacturer Sanofi Pasteur, based in Lyon, France, has spent more than 20 years developing a vaccine. The company claims it has the potential to reduce cases of dengue fever by 50% within five years in populations where the disease is endemic.