Sanofi may seek U.S. approval for Dengvaxia despite Philippines outrage
French pharmaceuticals group Sanofi says it will decide shortly whether to seek regulatory approval for dengue vaccine Dengvaxia in the United States, saying it was committed to the medicine despite a health scare in the Philippines.
David Loew, the head of Sanofi Pasteur, the group’s vaccines division, said the company had complied with all regulations and had no regrets about the vaccine, Dengvaxia, was developed despite the Philippines suspending a vast government immunization program because of safety concerns.
“On the whole path of development, we always worked with the WHO and experts in the dengue community. We were always transparent,” Loew told Reuters in an interview, referring to the World Health Organization and other regulators.
“You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently.”
Loew said the company was contemplating the possibility of filing an application for the use of Dengvaxia in the United States and that a meeting with the Food and Drug Administration would take place within two months.
Any decision would be taken after the meeting, he said.
Some experts have argued Sanofi and regulators may have ignored warnings about how the vaccine was developed, but executives at Sanofi denied any errors.
Dengvaxia has been approved and registered in 19 countries, mostly in the developing world. It is currently under review by the European Medicines Agency.