Dengvaxia was approved by Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) on Wednesday based on the results of two Phase III trials that demonstrated it is 60% effective at preventing dengue virus infection.
The vaccine contains weakened versions of the four confirmed dengue virus serotypes. An unconfirmed fifth serotype that scientists claimed to have found in 2013 is not included.
Sanofi produces the viruses at a purpose built manufacturing plant in Neuville-sur-Saone, France.
The facility was commissioned in 2009 when Sanofi stumped up €350m ($479m) to build it years before it knew if the vaccine would be approved.
Spokesman Alain Bernal told us “We decided to take an ‘industrial risk’ in 2009 and invest in the facility because we did not want there to be a three to five lag period between Dengvaxia being licensed and available.”
Pre-approval production
Work on the facility was completed in 2013 and Sanofi started producing Dengvaxia later that year in parallel with the two Phase III studies.
At the time, Sanofi spokesman Jack Cox told us the approach would reduce time to market and show regulators the manufacturing process is robust.
"Up to 70% of the time it takes [to make Dengvaxia] is related to the quality control measures and tests that must be in place," Cox said
He added that “any approval would require that we show consistency in our production process, hence we are able to produce batches repeatedly with the same characteristics."
Launch in early 2016
The dengue viruses made in Neuville-sur-Saone – which are produced in sufficient quantity to make 100m doses of vaccine a year - are sent to Sanofi’s facility in Val de Reuil in Normandy where they are combined and formulated into the final product.
Sanofi has said it plans to launch Dengvaxia in Mexico “early next.”
While Bernal could not give a precise date for the Mexico launch he did confirm that “doses are ready to be shipped to Mexican authorities.”