The Philippines government plans to sue Sanofi over its dengue fever vaccine after the French drugmaker warned that the vaccine may cause more severe symptoms on those who had not been previously infected by dengue.
Sanofi’s Dengvaxia was used in the world’s first mass immunization program against dengue fever, which was started last year. Roughly 830,000 children have been vaccinated.
Last week, Sanofi proposed that, based on trial data, national regulatory agencies update label information requesting that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. The new prescribing information will state that for individuals who have not been previously infected by dengue virus, vaccination should not be recommended.
After the warning, Philippines regulators suspended sales of Dengvaxia and the country’s health secretary said the government will seek a refund for unused vaccines as well as an indemnity fund in case vaccinated children begin manifesting severe symptoms.
Speaking before senators, Sanofi's Thomas Triomphe said there have been no deaths linked to the controversial dengue vaccine, which is still being used in 11 other countries.
Read the press release on the Sanofi Philippines site