By Karen Lema and Matthias Blamont
MANILA/PARIS (Reuters) – The Philippine Department of Justice on Friday said it had found probable cause to indict officials from French drugmaker Sanofi and former and current Philippine health officials over 10 deaths it said were linked to use of a dengue vaccine.
It recommended charges be filed in court for multiple counts of reckless imprudence resulting in homicide, due to what it said were procedural lapses and irregularities in implementing a Philippine dengue immunization program using Sanofi’s Dengvaxia.
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 has repeatedly said Dengvaxia is safe and effective and, on Friday, rejected the justice department’s recommendations.
“We strongly disagree with the findings made against Sanofi and some of its employees and we will vigorously defend them,” a spokesman said in an emailed statement, adding it was not appropriate to comment further as proceedings were ongoing.
Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.
Approved in late 2015 as the world’s first vaccine to treat the condition, Dengvaxia has rapidly become Sanofi’s most problematic program to date.
The company acknowledged two years ago its use could, in some cases, increase the risk of severe dengue in people who had not been previously exposed to the disease, limiting access to vaccine after deaths of children were reported in the Philippines.
The World Health Organization (WHO) advises the vaccine should only be used after testing individuals to assess whether they have ever been exposed to the disease.
Despite concerns around its use, the European Medicines Agency has approved Dengvaxia and the U.S. Food and Drug Administration has granted priority review with a decision expected in May.
However, the Philippines has permanently halted the sale, distribution and marketing of Dengvaxia, which was initially seen as a potential $1-billion-a-year-plus product.
Net sales of the vaccine stood at 3 million euros ($3.42 million) in 2017. Sanofi did not provide a figure for 2018.
The Philippines justice department statement did not say Dengvaxia had caused the deaths, but it quoted excerpts from a resolution by prosecutors that said the 20 individuals had exhibited an “inexcusable lack of precaution and foresight”.
It said the government registered and bought Dengvaxia for its immunization program with undue haste.
The Philippines started rolling out the vaccination program in 2016 in a bid to dramatically reduce as many as 200,000 domestic dengue cases a year. It spent 3.5 billion pesos ($67.7 million) on the program during which it immunized 800,000 children with Dengvaxia.
But that drive came under heavy scrutiny the following year, with critics and some lawmakers voicing concerns about the speed at which the government sought to register, procure and distribute Dengvaxia among schools and clinics.
A criminal investigation and two congressional inquiries have already taken place and the Philippines last month revoked the product’s license after concluding Sanofi had failed to meet directives issued by regulators.
Justice undersecretary Markk Perete told Reuters that there were 35 deaths under investigation, 10 of which were the basis for the charges announced on Friday.
Perete said the 20 individuals faced up to six years in prison for each of the alleged offences. All but two officials could be charged with eight counts of reckless imprudence resulting in homicide, he said.
A Sanofi source with knowledge of the situation said the Philippine prosecutors’ criticism was vague and they were mostly interested in the processes by which the product was approved.
Separately to the case announced on Friday, the Philippines has tasked a panel of medical experts to investigate the deaths of scores of children who received the vaccine, to establish whether or not Dengvaxia was a contributing factor.
The panel’s head, Juliet Aguilar, told Reuters that medical records of 119 victims were being looked into as of Friday.
The 20 officials named by the justice department on Friday had shown neglect in having “totally disregarded the identified risks and adverse effects of the vaccine”, the resolution said.
The department said those risks “materialized with the death of the victims”.
It also said Sanofi had failed to closely monitor the recipients of Dengvaxia, nor did it extend medical assistance to victims or their families, even after reports of “serious adverse reactions” surfaced.
(Additional reporting by Neil Jerome Morales in Manila; Editing by Nick Macfie and Kirsten Donovan)