‘NO CASES OF DEATH’ | Watch: Sanofi exec apologizes over ‘confusing’ advisory on Dengvaxia’s ‘severe’ dengue effect

December 13, 2017 - 9:13 PM
InterAksyon file photo of Sanofi Pasteur Asia Pacific head Thomas Triomphe (right)

MANILA, Philippines — An official of French pharmaceutical giant Sanofi Pasteur on Wednesday apologized to members of the Philippines’ congressional health committee for issuing a global advisory that its vaccine may cause severe dengue among those who had received Dengvaxia shots prior to contracting dengue.

Thomas Triomphe, Sanofi’s vice president for Asia Pacific, told the House panel chaired by Surigao del Sur Rep. Johnny Pimentel that he understood the parents’ concerns and he was sorry for the confusion if the language used in the advisory issued last November 29 had caused misunderstanding.

In a statement sent to the media, Triomphe explained that while Sanofi used severe dengue, the term did not mean that those who had received Dengvaxia shots and then got sick with the mosquito-borne disease would suffer from fatal conditions.

He clarified that “there were no cases of shock or death” among those who were injected with the vaccine and then contracted dengue, adding that “severe dengue in medical language, includes the usual symptoms experienced by a dengue sufferer like fever and bleeding gums as observed during the clinical trials.”

Triomphe said Sanofi only used the term severe dengue because the pharmaceutical sector “is a highly regulated industry” and it was also the term that had to be used by the firm in its clinical study.

“Sanofi Pasteur strongly affirms that it followed Philippine regulatory procedures when it entered into an agreement with the Department of Health to supply the agency with the anti-dengue vaccine, Dengvaxia,” said Triomphe.

The Sanofi executive added that Dengvaxia “is still the only effective anti-dengue vaccine in existence in the world” and “is a product of 20 years of tireless research, which was hailed by top global experts as a breakthrough vaccine.”

“In its dealings with 19 countries throughout the world, Sanofi Pasteur has followed every policy as set by the national regulatory agency from product registration to procurement. Sanofi Pasteur, being a multinational company is bound by rules on transparency and anti-corruption,” said Triomphe.

“Likewise, Sanofi Pasteur wants to assure Filipinos that Dengvaxia is safe and highly beneficial for those who have been previously infected by dengue. Its efficacy has been proven in clinical trials and even Philippine medical experts attest to its effectiveness,” he added.

Sanofi said that “as part of its responsibility as a manufacturer…it is continuously working with government in updating the product label and informing Healthcare professionals on the new findings regarding the dengue vaccine.”

“In case there is an adverse report against the vaccine, Sanofi Pasteur is committed to cooperate with authorities in providing information,” the firm added.