Philippines: Sanofi officials and government charged with vaccine-related deaths

MANILA (Reuters) – The Philippine Justice Ministry said on Friday that it had found a probable cause to charge officials of French drug maker Sanofi and former and current health officials of the Philippines on 10 deaths that it said would be linked. to the use of a dengue vaccine.

He recommended charging the court with charges for several reckless rudiments leading to a homicide, due to alleged procedural irregularities and irregularities in the implementation of a vaccination program. Philippines against dengue fever using Sanofi dengvaxia.

He recommended that six Sanofi officials, mainly company representatives in the country, be indicted along with 14 former and former health officials in the Philippines, including the former Minister of Health, Janette Garin. .

Sanofi has repeatedly stated that dengvaxia is safe and effective. The drug maker Friday rejected the recommendations of the Justice Department.

"We strongly disagree with the conclusions drawn against Sanofi and some of its employees and we will defend them vigorously," said a spokesman, adding that he was not to comment, the proceedings continued.

The Ministry of Justice did not state in its statement that Dengvaxia had caused the death, but quoted excerpts from a prosecutors' resolution claiming that the 20 individuals had been shown a "inexcusable lack of precautions and foresight".

He added that the government had registered and bought Dengvaxia for its vaccination program with excessive haste.

Dengue is a tropical mosquito-borne disease that kills an estimated 20,000 people a year and infects hundreds of millions of people.

The Philippines began deploying the immunization program in 2016 with the aim of drastically reducing up to 200,000 dengue cases in the country each year. He spent 3.5 billion pesos ($ 67.7 million) on the program during which he vaccinated 800,000 children with Dengvaxia.

But this campaign was scrutinized the following year, with critics and some legislators mistrustful of how quickly the government was trying to register, buy and distribute Dengvaxia in schools and clinics.

SECURITY CONCERNS

This suspicion was exacerbated by concerns about the safety of the vaccine after Sanofi, at the end of 2017, declared that dengvaxia could increase the risk of severe dengue in children who have never been exposed to the virus.

A criminal investigation and two congressional investigations have taken place and the Philippines has definitely suspended the sale, distribution and marketing of Dengvaxia last month, after finding that Sanofi had not complied with the regulatory authorities' directives.

Undersecretary of Justice Markk Perete told Reuters that 35 people were under investigation, 10 of whom were at the base of the charges announced Friday.

Perete said the 20 people spent up to six years in prison for each of the alleged offenses. All but two officials could be charged with eight counts of reckless indigence leading to a homicide, he said.

A Sanofi source familiar with the situation said that Filipino prosecutors' criticism was vague and that they were more interested in the product approval process.

In addition to the case announced on Friday, the Philippines commissioned a group of medical experts to investigate the deaths of dozens of vaccinated children, to determine whether or not dengvaxia was a contributing factor.

The head of the committee, Juliet Aguilar, told Reuters that the medical records of 119 victims were under review Friday.

The 20 officials appointed by the Justice Ministry Friday were negligent in "totally neglecting the identified risks and adverse effects of the vaccine," said the resolution.

The ministry said that these risks "were materialized by the death of the victims".

Sanofi also did not closely monitor the people who received dengvaxia nor did it extend medical assistance to the victims or their families even after the announcement of " serious adverse reactions ".