PARIS (Reuters) - Use of Sanofi’s dengue vaccine, the world’s first approved shot against the mosquito-borne virus, is to be strictly limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection. The French drugmaker said in a statement on Wednesday that as a result it would book a charge in its fourth-quarter results of around 100 million euros ($118.57 million).
CNN Philippines - In a statement, Sanofi said Dengvaxia provided persistent protection against dengue fever to those who had prior infection.
"For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection," it said.
Sanofi, one of the world's top companies in pharmaceutical research and development, said it would ask national regulatory agencies to update the product label to reflect the new findings.
"Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). For individuals who have not been previously infected by dengue virus, vaccination should not be recommended," the statement read.
Dengvaxia is a three-dose series licensed for use on people between 9 and 45 years old.
In 2016, the Philippines became the first country to implement the use of Dengvaxia through a school-based dengue immunization program, which initially covered Grade 4 students in the National Capital Region, Central Luzon, and CALABARZON (Cavite, Laguna, Rizal, Quezon).
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