Sanofi agrees to pay for proven Dengvaxia adverse events in the Philippines

Officials in the Philippines have been questioning Sanofi about Dengvaxia for months. (Pixabay)

Sanofi had already agreed to refund the Philippines for unused Dengvaxia shots as part of an ongoing safety controversy there. Now an executive has told legislators the company will "shoulder the cost" of any adverse events that are scientifically linked to vaccination.

Speaking at a Senate hearing on Monday, Sanofi Pasteur Asia-Pacific head Thomas Triomphe said that “should there be any case related to vaccination, death or any other case, we will shoulder the cost, if there is a causality that has been demonstrated through scientific evidence," according to The Inquirer.

The testimony came as a safety controversy for the vaccine intensified over the last week, with reports that preliminary autopsy results showed a common cause of death among children who died after vaccination, though experts said no causal link was found. At the same hearing, an expert panel from the Philippine General Hospital reported that there was "no evidence linking Dengvaxia to any deaths," a Sanofi spokesperson told FiercePharma on Monday.

"This finding is consistent with the fact that Sanofi Pasteur has not had any reports of deaths due to vaccination in any of the clinical studies of the vaccine involving over 40,000 people nor in the public or private use of Dengvaxia where over 1 million dose of the vaccine have been administered in several endemic countries," the spokesperson added.

RELATED: Philippines suspends Dengvaxia approval, fines Sanofi a symbolic $2,000

Triomphe's commitment came after weeks of questioning by officials into the Philippines' Dengvaxia campaign and the vaccine itself. Back in November, the drugmaker said Dengvaxia can cause more serious dengue cases in people who haven't had previous exposure to the virus, prompting a fast response from officials.

Quickly after Sanofi sent the advisory, the country canceled future immunizations and struck up an investigation into its $70 million vaccination program. Legislators and families have said the government entered the deal too quickly, and some have suggested collusion. 

As the controversy continued, the country suspended its Dengvaxia marketing approval early this month and fined Sanofi $2,000. Last week, the drugmaker agreed to refund the government $28 million for unused doses as reports circulated that early autopsy results indicated a common cause of death among children who died after receiving the shots. Officials stressed no causal link has been proven. 

In the wake of the hearing, a spokesperson said on Monday that Sanofi "has been and will continue to work with the Philippines regulatory authorities, Department of Health and all other health and community organizations to collaborate and cooperate in finding the best solution for dengue prevention in the Philippines."

RELATED: Sanofi to refund Philippines for $28M worth of unused Dengvaxia doses

The company added that it hopes for "continued dialogue" so the parties can "achieve our mutual goal of reducing the human and economic burden of dengue in the country through an integrated approach to disease prevention."

Sanofi spent $1.5 billion and 20 years developing the world's first dengue vaccine, but so far the product has not taken off commercially. Takeda is working on a late-stage candidate that could challenge Sanofi's shot. Dengvaxia is approved in 19 countries around the world, but most of its use has been in the Philippines and in Brazil's Parana state.