MANILA, Philippines – The Department of Health (DOH) is set to file a civil case against Sanofi Pasteur for its refusal to comply with the government’s demand for a full P3 billion refund over the Dengvaxia dengue vaccine.

Health Secretary Francisco Duque III told Rappler his staff is already in talks with the Office of the Solicitor General (OSG), which would aid the department in building a case against the French pharmaceutical giant.

“We will file a civil against Sanofi with the OSG. We’re just preparing the case build-up and I’ve instructed my staff to submit pieces of evidence to support our case,” said Duque in a phone interview on Tuesday, February 20.

He added the DOH may also possibly file a criminal case against the manufacturer of the controversial vaccine used in the now-suspended dengue immunization program. (READ: TIMELINE: Dengue immunization program for public school students) 

“It’s a civil case potentially, without prejudice to filing a criminal case if we can establish evidence,” said Duque. 

The DOH chief had first written a letter to  Sanofi Asia Pacific head Thomas Triomphe demanding the company to refund about P1.4 billion, equivalent to the unused Dengvaxia vials left in warehouses across the country. Triomphe agreed. 

But the company refused when Duque wrote another two letters demanding Sanofi to also return around P2 billion to the government, equivalent to the amount of vaccine vials consumed when the immunization program was still in operation.

Sanofi argued a full refund would imply their vaccine is ineffective. The company stands by their product, even if they had announced in November 2017 Dengvaxia causes a person to develop severe dengue symptoms if he or she had not been infected  by the virus prior immunization.

Sanofi also said that they never claimed their product was 100% effective. 

Duque immediately suspended the vaccination program, but not more than 837,000 Filipino gradeschoolers in 3 regions received the risky vaccine. 

Now, DOH is on a heightened surveillance of the health of all vaccinees, whose medical expenses will be shouldered by the government should they be hospitalized due to dengue. 

A total of 3 out of 14 vaccinated children whose medical records were reviewed by the University of the Philippines-Philippine General Hospital experts died of dengue despite receiving Dengvaxia. – Rappler.com