Sanofi’s Dengvaxia trouble in the Philippines shows no sign of abating. Local health authorities are digging into a growing list of deaths that might be linked to the shot, and four new families have filed complaints that call for prosecutors to consider criminal charges against officials with the government, Sanofi and distributor Zuellig.
The Philippine Public Attorney’s Office (PAO) helped families of four children who died after receiving the controversial dengue shot file their criminal complaints with the Department of Justice last Thursday, according to multiple local reports.
The new complaints target eight Sanofi executives, most of them with local management titles, 15 managers at distributor Zuellig Pharma, and Department of Health (DOH) officials involved in approving and purchasing the vaccine, including former department head Janet Garin.
The PAO forensics chief said all four children, who died 11 days to eight months after vaccination, had no history of dengue infection, and forensic investigations showed extensive organ bleeding, which is characteristic of severe dengue fever, according to the Manila Bulletin. Officials have yet to establish a link between Dengvaxia vaccination and any of the deaths said to be associated with it.
A Sanofi spokesperson told FiercePharma that the company has yet to receive any legal action directly from the complaints filed to request criminal charges, and said “Sanofi Pasteur will continue to cooperate in full transparency with authorities and we remain committed to following all laws and regulations wherever we do business.”
In the Philippines, a criminal complaint acts as a call for state prosecutors at the DOJ to bring charges against a person. These are not the first complaints families with Dengvaxia-vaccinated children have submitted. A previous one filed last December by more than 70 families targets five Sanofi executives all the way to the top, including CEO Olivier Brandicourt.
Still, no death has so far been directly linked to the vaccine. One study examining 14 deaths, conducted by the University of the Philippines-Philippine General Hospital (UP-PGH), found “causal association” between inoculation and three deaths, but came shy of verifying a link without further testing.
The DOH is expected to release findings this week from the second such investigation on another 17 suspected Dengvaxia deaths, and it is preparing medical records from an additional 31 cases for UP-PGH experts’ assessment, according to The Manila Times.
Sanofi’s recent analysis posted in November suggested that Dengvaxia could worsen dengue infections in dengue-naïve populations, prompting the Philippine government to suspend its mass immunization program. The French drugmaker has so far returned about $23 million worth of unused doses but has declined twice the government’s request to refund for used shots as it worries that would imply it’s ineffective.