Sanofi to refund DOH P1.4 B for unused vaccine

Pharmaceutical firm Sanofi Pasteur has agreed to refund the Department of Health (DOH) P1.4 billion for the unused vials of Dengvaxia vaccine.

In a statement released yesterday, Sanofi “responded positively” to the demand of Health Secretary Francisco Duque III for the reimbursement of the vaccines not used by the government in its public vaccination program against dengue.

“Our decision to reimburse for unused dosLess es is not related to any safety or quality issue with Dengvaxia. Rather, Sanofi Pasteur hopes that this decision will allow us to be able to work more openly and constructively with the DOH to address the negative tone towards the dengue vaccine in the Philippines today,” the company said.

Sanofi noted it “strongly believes that this tone is due to a misunderstanding of the benefits and risks associated with the dengue vaccine and a lack of awareness amongst

the general public, particularly parents of vaccinated children, that the overall benefit of dengue vaccination remains positive in high endemic countries like the Philippines.

“We have asked the DOH for a meeting to discuss any questions they may have regarding the reimbursement and also to find ways to inform the Filipino public in a more balanced and evidence-based way on dengue vaccination while also restoring public trust in vaccination programs, in general.”

Sanofi, however, has not responded to Duque’s demand to do serotesting of over 830,000 vaccinated children to determine whether or not they had dengue prior to vaccination.

Last week, Duque had sent two letters to Sanofi Pasteur head for Asia Pacific Thomas Triomphe, demanding reimbursement and the conduct of serotesting.

In an interview yesterday, Duque maintained the DOH is now studying how it could get back from Sanofi some P2 billion that they paid for the used vaccines in the wake of the mess created by Dengvaxia.

This as the Public Attorney’s Office (PAO) reported yesterday that the children who died after being given Dengvaxia by the DOH could have died of “something else that is still directly linked to the vaccine.”

PAO Forensic Laboratory director Erwin Erfe said the agency has autopsied seven children and is looking at other possible causes of death but which could still be associated with the vaccine.

“I’m reviewing their medical history. Their death is sudden. From the time of the Dengvaxia vaccination, to the onset of symptoms, to the progression up to death, it’s so fast. This may not be a simple case of being bitten by mosquito but may be directly related to Dengvaxia,” he claimed in a forum at the Manila Hotel.

According to him, one of the children they autopsied had died within 12 hours after being vaccinated, while another perished after 48 hours.

He said two viruses were introduced to the children when they were vaccinated with Dengvaxia. These are the dengue virus and yellow fever, which can only be found in the African region.

“When this vaccine was developed, the yellow fever virus was used as base and then antigens coming from the dengue virus were added. So in effect, you are introducing two live viruses to the children although they have been attenuated,” he added.

Erfe has underscored the need to study the implications of the vaccines because there was a pattern of enlarged organs, typical to yellow fever, and bleeding typical of dengue.

For his part, Duque said they will coordinate with the World Health Organization (WHO) to possibly do polymerase chain reaction (PCR) testing to determine if the vaccinated children indeed developed yellow fever.

The DOH’s Research Institute for Tropical Medicine has the capability to perform the PCR but it would be better to have the WHO do it in the spirit of transparency, the health chief said.