Philippines FDA bans Sanofis dengue vaccine due to compliance issue

Reports confirm that the Philippines has revoked the product license for Dengvaxia, the dengue vaccine from Sanofi, after the France-based pharmaceutical company failed to comply with directives of regulators. Apparently, the sale, distribution and marketing of the dengue vaccine has been stopped permanently in the country.

Philippines FDA stated that Sanofi was not able to meet the post-marketing authorization requirements as of December last year. Sanofi, however, has disagreed with the findings of the FDA.

Nela Charade Puno, the Director General for FDA, had mentioned that the registration certificates for products of Dengvaxia are revoked owing to audacious defiance of the directives of the agency by Sanofi.

Supposedly, Sanofi said in a statement that Sanofi Pasteur has respectfully disagreed with Philippines FDA’s conclusions mentioned in the order and believes the agency took this decision regardless of the company’s diligence, such as regular updates about the status of post-marketing studies as well as the submission of documents regarding completed post-approval commitments.

Sanofi stated that the FDA had not questioned the efficacy and safety of its Dengvaxia vaccine. The company has also filed a motion for reconsideration. In December 2017, after the French drug maker had warned about the possibility of Dengvaxia vaccine worsening the disease in some cases, its product registration got first suspended.

Sanofi had said in late 2017 that, in children who were never exposed to the dengue virus before, Dengvaxia could elevate the risk of severe dengue. This had allegedly triggered two congressional inquiries as well as a criminal investigation in the country, where almost 800,000 children of school-going age had been vaccinated already.

Reportedly, the Philippines government had spent nearly $67 million (3.5 billion pesos) in 2016 for a Dengvaxia immunization program for lowering dengue cases, which were estimated to reach about 200,000 each year.

FDA’s legal department officer-in-charge, Michelle Lapuz, informed that Sanofi would be able to reapply for a product license, but owing to the company’s history of non-compliance, the application may be treated as being a high risk.