Philippines: Sanofi Officials and Government Charge for Dengue Vaccine

MANILA / PARIS (Reuters) – The Philippine Justice Ministry said on Friday it had found a likely cause to charge officials of French drug maker Sanofi and former and current health officials in the Philippines, out of 10 deaths, which 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.

Prosecutors said that six Sanofi officials, mainly business representatives in the country, and fourteen former and former health officials in the Philippines, including former health minister Janette Garin, should be charged.

Sanofi has repeatedly stated that Dengvaxia was safe and effective and on Friday rejected the recommendations of the Ministry of Justice.

"We strongly disagree with the conclusions reached against Sanofi and some of its employees and we will defend them vigorously," said a spokesman in a statement sent by email, adding that it was not appropriate to make further comments as the procedure was ongoing.

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

Approved at the end of 2015 as the first vaccine in the world to treat this disease, dengvaxia has quickly become Sanofi's most problematic program to date.

The company acknowledged two years ago that its use could, in some cases, increase the risk of severe dengue in people who have never been exposed to the disease, thus limiting access to the vaccine after the death of children in the Philippines.

"INEXCUSABLE"

The World Health Organization (WHO) recommends that the vaccine be used only after testing individuals to assess whether they have ever been exposed to the disease.

Despite concerns about its use, the European Medicines Agency has approved Dengvaxia and the US Food and Drug Administration has given priority to the review. A decision is expected for May.

However, the Philippines has definitely stopped the sale, distribution and marketing of Dengvaxia, which was initially considered a potential product of one billion dollars a year or more.

Net sales of the vaccine amounted to 3 million euros (3.42 million USD) in 2017. Sanofi has not provided a figure for 2018.

In its statement, the Philippine Justice Ministry did not say that dengvaxie had caused the death, but quoted excerpts from a prosecutors resolution stating that the 20 people had been shown to have died. an "inexcusable lack of precautions and foresight".

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

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, critics and some lawmakers worried about how quickly the government was trying to register, buy and distribute Dengvaxia in schools and clinics. .

SECURITY CONCERNS

A criminal investigation and two Congressional investigations have already taken place and the Philippines revoked the product license last month after finding that Sanofi had not complied with the guidelines issued by the regulators.

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 mainly interested in product approval processes.

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

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 ".