Despite being at the center of backlash in the Philippines due to safety concerns of its dengue vaccination, the French pharmaceuticals group Sanofi may soon seek regulatory approval in the United States.
David Loew, head of the group’s vaccines division Sanofi Pasteur, told Reuters that a meeting with the U.S. Food and Drug Administration (FDA) would happen within two months. Any decision would be made after.
Sanofi’s Dengvaxia — the world’s first-ever dengue vaccine — caused havoc in the Philippines last November when the pharmaceutical company revealed that the vaccination could actually be harmful for those who had not been infected before, prompting an investigation by the Philippine government.
The Philippines was the first country to introduce the mass immunization program and suspended the vaccine use in December when Sanofi made the admittance.
Loew told Reuters that the company had no regrets about Dengvaxia and that it had observed all regulations.
“On a whole path of development, we always worked with the WHO and experts in the dengue community. We were always transparent,” said Loew, referring to the World Health Organization (WHO).
He added, “You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say now, we would not have done anything differently.”
Some experts say that Sanofi and its regulators discounted the vaccine’s warnings and risks, despite knowing about some of them as early as 2015. Philippine government officials have been pressing for insight on the company’s advertising campaign and push to vaccinate children.
Documents filed in Singapore revealed that the vaccine’s potential risks were reported to regulators by Sanofi back in 2016, allowing commercial sale 10 months after the Philippines. Sanofi Pasteur’s Asia-Pacific head Thomas Triomphe said that no definitive knowledge of the risks were made before November 2017, according to the Philippine Daily Inquirer.
Former Philippine President Benigno Aquino III found himself amidst the mess and said he would not have approved of the Dengvaxia immunization program had he known the risks.
Aquino, former Department of Health officials, and Sanofi Pasteur are currently facing a graft complaint filed last month.
The Philippine government also filed a lawsuit last month against Sanofi, demanding it provide compensation of up to 4.2 million pesos ($81,600) for the parents of Anjelica Pestilos, 10, whose death was allegedly a result of Dengvaxia.
More than 800,000 Filipino children aged nine and above had received the dengue vaccine. Direct correlations between Dengvaxia and children deaths have not yet been established, but experts said three out of 14 children who died from dengue had received at least one shot of Dengvaxia.
The controversial dengue vaccine has been registered in 19 countries and is currently being evaluated by the European Medicines Agency.
A public interest lawyer recently informed Malacañang that Sanofi Pasteur is dealing with over 2,000 lawsuits in many countries, reported the Inquirer.
In 2012, the company disclosed cooperation with the U.S. Justice department which investigated the promotion of Sanofi drugs Seprafilm and Sculptra, with the company paying $109 million in claims for the sampling of another drug, Hyalgan.