Amid PH outrage, Dengvaxia eyeing approval in US

Published March 8, 2018, 10:00 PM

by Mario Casayuran and Vanne Elaine Terrazola

By Reuters

Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said in Paris, France on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmakers vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the US Food and Drug Administration (FDA).

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunization program last year because of safety concerns.

Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.

Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

“On the whole path of development, we always worked with the World Health Organisation (WHO) and experts in the dengue community. We were always transparent,” Loew told Reuters in an interview, referring to the WHO 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.”