MANILA (Reuters) – The Philippine Department of Justice said on Friday it had found probable cause to indict officials from French drugmaker Sanofi and former and current Philippine health officials over a series of deaths related to a dengue vaccine.
It recommended charges be filed in court for reckless imprudence resulting in homicide, due to what it said were procedural lapses and irregularities in the implementation of a dengue immunization program in 2016 using Dengvaxia.
It recommended that six Sanofi officials and 14 current and former Philippine health officials be charged, including former health minister Janette Garin. It did not say when the charges would be filed.
Sanofi could not immediately be reached for comment. The drugmaker has repeatedly said Dengvaxia was safe and effective.
Quoting excerpts from a resolution on the case, the department said prosecutors had found the 20 individuals had exhibited an “inexcusable lack of precaution and foresight” and had registered and purchased Dengvaxia for its immunization program with undue haste.
In late 2017, Sanofi said Dengvaxia could increase the risk of severe dengue in children who had never been exposed to the virus, triggering two congressional inquiries and a criminal investigation in the Philippines where 800,000 school-age children had already been vaccinated.
The government spent 3.5 billion pesos ($67.7 million) on the Dengvaxia public immunization program to reduce the 200,000 dengue cases reported every year.
Those to be included in the indictment exhibited neglect having “totally disregarded the identified risks and adverse effects of he vaccine,” the department said, citing the resolution, adding those risks resulted in the deaths.
The Philippines has permanently halted the sale, distribution and marketing of Dengvaxia in the country after the French drug maker failed to meet the directives of regulators.
Reporting by Karen Lema; Additional reporting by Matthias Blamont in PARIS; Editing by Martin Petty & Kim Coghill