Sanofi’s controversial dengue vaccine may still hit US market, despite Philippines disaster

pharmafile | March 7, 2018 | News story | Sales and Marketing FDA, Philippines, Sanofi, US, dengue, dengvaxia, pharma 

Sanofi has revealed that the ongoing debacle in the Philippines concerning its dengue vaccine Dengvaxia has not deterred it from looking to market the drug elsewhere as the company announced it would soon reach a decision on whether or not to file for regulatory approval in the US.

“On the whole path of development, we always worked with the WHO and experts in the dengue community. We were always transparent,” remarked David Loew, head Sanofi’s vaccines division Sanofi Pasteur, in an interview with Reuters. “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.”

Sanofi still maintains that there has been no wrongdoing on its part despite arguments that the firm and regulators may have ignored warnings concerning the development of the vaccine. Loew confirmed that Sanofi would reach a decision regarding a US regulatory filing within the next two months. The vaccine is approved in 19 countries and is currently undergoing review in Europe.

The rollout of Sanofi’s vaccine as part of the Philippines’ $70 million Department of Health (DOH) immunisation programme has proved to be a nightmare for both parties: the vaccine had been administered to more than 800,000 children in the country before it became apparent that it can cause severe dengue symptoms in patients who had not previously been exposed to the virus. Needless to say, the programme has since been suspended because of the safety implications.

While the company confirmed that it would “shoulder the cost” of adverse events as a result of vaccination, Sanofi later refused the DOH’s demands to reimburse $28 million to cover the unused vials of the vaccine, because, as the French drugmaker argued, that would imply that the therapy didn’t work, pointing to the verdict of a Philippine General Hospital panel that it had not directly caused any deaths. This led to the Philippine Government launching legal action against the firm last month.

Matt Fellows

Related Content

Bristol Myers Squibb’s NDA accepted by FDA

Global pharmaceutical company Bristol Myers Squibb (BMS) has announced that its New Drug Application (NDA) …

Pulse Medical receives FDA BDD for its μFR system

Shanghai, China-based Pulse Medical Technology has announced that its 4th generation μFR system has received …

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral …

Latest content