Sanofi, which spent two decades developing the world's first dengue vaccine, said the product should not be recommended for use in people who have not been previously infected by the virus.
Cases of severe disease could occur in people who contracted dengue after vaccination if they had never been infected before, according to a new analysis of safety data on Sanofi's Dengvaxia vaccine.
As a result, the French drugmaker proposed that national regulatory agencies update the prescribing information, or labeling, and requested that healthcare professionals assess the likelihood of prior dengue infection in an individual before vaccinating. Sanofi said its label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under review.
Sanofi will record a charge reflecting depreciation of inventories as well as accelerated depreciation of other assets, and estimates the impact on its business net income to be in the range of €100 million after tax in the fourth quarter. The company reiterated the 2017 financial guidance it provided on Nov. 2, saying earnings will be broadly stable in 2017 compared with 2016.
Sales of Dengvaxia have already been stymied by economic and political changes in Latin America, where the mosquito-borne virus is endemic, since the vaccine won its first marketing approval in Mexico in 2015. Dengvaxia brought in €55 million last year, or 1.2% of Sanofi's total vaccines revenue, according to the company's 2016 annual report.
Dengvaxia has been tested in 25 clinical trials in 15 countries involving 40,000 people, of whom 29,000 received the vaccine. The new safety analysis was based on up to six years of data evaluating long-term safety and efficacy of Dengvaxia in people who had been infected with dengue prior to vaccination and those who had not.
The analysis confirmed that Dengvaxia provided persistent protective benefit against dengue fever in those who had previously had the disease.
Dengvaxia is indicated for individuals age 9 and older in most countries that have approved its use.
Other pharmaceutical companies targeting dengue include Takeda Pharmaceutical Co. Ltd. and ABIVAX SA.
