Regulators in the Philippines said Friday that they plan to file criminal charges against executives from Sanofi, as well as current and former health officials in the country, over the deaths of children given the company's dengue vaccine Dengvaxia. The Philippine Department of Justice faulted Sanofi "for failing to actively monitor and conduct close surveillance of Dengvaxia recipients."
Specifically, authorities called for charges to be filed for multiple counts of reckless imprudence leading to homicide as a result of procedural lapses and irregularities in implementing a dengue immunisation programme in the Philippines using Dengvaxia. The resolution claims that the 20 charged officials, including six Sanofi employees, "totally disregarded the identified risks and adverse effects of the vaccine."
The Philippines further alleged that Sanofi failed to monitor patients who received Dengvaxia or provide medical assistance to victims or their families, even after reports of "serious adverse reactions" appeared. According to Justice Undersecretary Markk Perete, 35 deaths in total are under investigation, 10 of which formed the basis of the charges. Perete noted that each charge carries a maximum sentence of six years in prison.
The Philippines paused its dengue immunisation programme in December 2017 after Sanofi announced that Dengvaxia can cause severe illness in patients without prior exposure to the dengue virus. Soon thereafter, the country ordered the French drugmaker to halt sales of the vaccine.
In response to the news, Sanofi said "we strongly disagree with the findings made against Sanofi and some of its employees and we will vigorously defend them." While the Department of Justice did not attribute Dengvaxia directly to the deaths, it claimed that the individuals to be charged had exhibited an "inexcusable lack of precaution and foresight." Sanofi had previously stated that it was not aware of any deaths linked to immunisation with the vaccine.
Dengvaxia became the first dengue vaccine to win regulatory approval following its authorisation in Mexico in 2015. Subsequently, the World Health Organization's Strategic Advisory Group of Experts on Immunization recommended the vaccine for use in countries with high dengue transmission. More recently, Dengvaxia was approved by the European Commission, while a marketing application is currently being evaluated by the FDA.
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