Sanofi declines PH demand for full Dengvaxia refund

MANILA, Philippines – Arguing that it does not want to "create confusion" over the safety and effectiveness of a now-controversial dengue vaccine, French pharmaceutical giant Sanofi Pasteur on Monday, February 5, said it has "refused" the Philippines' demand that it get a full refund for the vials of Dengvaxia it purchased.

Thomas Triomphe, Asia Pacific head of Sanofi Pasteur, made the disclosure during a House of Representatives probe into alleged anomalies in the procurement of the vaccine for a mass immunization program.

He said his reply to the Philippine government was sent Monday morning. 

All in all, the Philippines spent more than P3 billion for the program. Of that amount, Sanofi has returned over P1.4 billion for unused vials.

Health Secretary Francisco Duque III earlier demanded that Sanofi give a full refund "because the purported or reported or claimed protection [of Dengvaxia] wasn't felt and wasn't there."

"The reason why [we rejected Duque's demand] is because doing so would imply that the product is ineffective, does not provide the effect provided which actually is not the case," said Triomphe during a hearing by two House committees.

He stood by earlier statements that Dengvaxia was still of use to the Filipino public since it "[made] sure that there are less dengue cases than not using Dengvaxia."

The Sanofi executive said a full refund would "create confusion into the mind of the population, of the parents who have kids who have been immunized… [it] would give a wrong impression of the efficacy of the product."

"The data remains quite clear that, in absolute terms, dengue vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden associated with this disease," Sanofi said in a separate statement.

Duque said they would "look at other available options" including legal remedies. He added, however, that they would wait for the findings of a Department of Health (DOH) task force, when asked how the department would ultimately respond to Sanofi's decision.

The mass immunization program has been contentious, as health experts insisted that more clinical trials must be done first. The health department, during the Aquino administration, pushed through with it anyway.

In November 2017, Sanofi released the results of a 6-year-long clinical trial, which showed that the vaccine posed a risk to persons who had never gotten the dengue virus prior to vaccination.

Both chambers of Congress are holding probes into alleged anomalies in the purchase of the vaccine and implementation of the program.

The Public Attorney's Office (PAO) has been exhuming and conducting autopsies on the bodies of vaccinated children who died due to various reasons.

Three out of 14 of these children died of dengue, according to a University of the Philippines-Philippine General Hospital panel tasked to investigate the cases.

Doctors, including a former health secretary, have called on the PAO to stop conducting autopsies and let "competent forensic pathologists" determine the causes of the children's deaths instead.

WATCH Monday's House hearing on the Dengvaxia controversy here Rappler.com