Philippines DOJ prepares charges to indict Sanofi officials over dengue vaccine mess

By PharmaCompass

2019-03-07

Impressions: 83 Article

In December 2015, Sanofi Pasteur, the vaccines division of the French drugmaker, had bagged the marketing approval of Dengvaxia in the Philippines, making it the first vaccine to be licensed for the prevention of dengue in Asia.

In December 2017, the vaccine ran into trouble as the Philippines government suspended it amid widespread fears about its safety. Over 830,000 school children had already been given the vaccine. The government then began investigations into Sanofi’s immunization program, which came under fire for discounting early signs that it could put some people at heightened risk of a severe form of the disease.

Last week, the Philippines Department of Justice said it had found reason to indict Sanofi officials and Philippine health officials over 10 deaths that it said were linked to the use of the dengue vaccine.

The prosecutors said six Sanofi officials, mostly country representatives of the firm, and 14 current and former Philippine health officials should be charged, including former health minister Janette Garin.

Sanofi rejected the justice department’s findings and reiterated that Dengvaxia is safe and effective. The company said it “strongly disagrees” with the findings made against Sanofi and some of its employees”. The drugmaker said it will vigorously defend its employees.

A week back, the government of Philippines had permanently revoked the Certificates of Product Registration (CPR) of the dengue vaccine, citing the continued failure of Sanofi Pasteur to submit post-approval commitment documents.

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