After two refusals from Sanofi to provide a refund for the controversial Dengvaxia program, officials in the Philippines say they are left with no options but legal action.
Sanofi on Monday rejected a second request for a refund from the government, according to numerous reports. In response, the Department of Health plans to sue and set up an indemnification fund for people who still get sick after receiving the dengue vaccine, according to the Inquirer.
The developments follow months of controversy after Sanofi disclosed in November that Dengvaxia can cause more serious dengue cases if given to those who haven't had prior exposure to the virus. The Philippines quickly stopped vaccinations as part of a government program and struck up investigations into the vaccine and the mass vaccination program. Months of tough talk and accusations about the procurement process followed.
Sanofi has already refunded €19 million ($23.44 million) worth of unused doses as a gesture of goodwill but has declined a full refund as it says that would imply the shot is ineffective. The entire program cost the Philippine government about $70 million.
Health Undersecretary Eric Domingo told reporters this week the Philippine DOH will likely file a civil case first "on the basis that what they really sold us was a defective product," according to the Inquirer. He added that Sanofi changed its stance about who could use the vaccine years after initial contract talks.
"So there’s an inherent problem in the product that they sold us,” he said, as quoted by the Inquirer.
Sanofi hit back, saying it never promised a vaccine that is 100% effective. The company said its vaccine "will provide a net reduction in dengue disease, including severe dengue and thereby reduce the overall public health burden with this disease" in the Philippines, according to the Inquirer.
The drugmaker reported Dengvaxia sales of just €3 million in 2017, down 98% from the prior year. It has stopped making new doses as it has enough stock on hand to last several years, a spokesperson previously told FiercePharma.
Sanofi spent $1.5 billion and 20 years developing the world's first dengue vaccine.