Philippines plans legal action against Sanofi over Dengvaxia safety scare: official

A Dengvaxia controversy has quickly swelled for Sanofi in the Philippines.

Sanofi only warned of a potential safety issue with its Dengvaxia shot a week ago, but a controversy over the vaccine has quickly exploded in the Philippines. Now, the nation's top health official says he'll ask for a refund and plans to take the drugmaker to court. 

In an interview with ABS-CBN News, Health Secretary Francisco Duque said there "seems to be an element of mental dishonesty" from Sanofi in the whole episode. The Philippines started its $70 million vaccination program last year, but it was only last week when Sanofi warned of an elevated risk for severe dengue in those who haven't had a previous infection.

Immediately after the advisory, the Philippines canceled future vaccinations and struck up an investigation. Asked whether the government will sue, Duque said "eventually that's where it's going to go." 

Aside from taking the drugmaker to court and asking for a refund, Duque said during the interview he'll ask the company to start an "indemnity fund" for any future hospital expenses related to Dengvaxia.

Responding in a statement to FiercePharma, a Sanofi spokesperson said the company is "surprised by the declarations of the Health Secretary." 

"Sanofi is a responsible company that has acted according to Philippine laws and regulations for the supply and sale of the vaccine according to the approved label in the country, and will continue to comply with any legal directive instructed by the Philippines health authorities," the spokesperson said. 

RELATED: Sanofi's Dengvaxia scrutiny mounts as Philippines slams brakes on dengue shots 

The World Health Organization quickly responded to the safety advisory as well, saying it would start a "full review" of Dengvaxia to issue a "revised guidance." Initially, the agency recommended the vaccine for areas with high dengue prevalence. Until its new review is complete, WHO says Dengvaxia should only be given to those who are known to have had a prior dengue infection. 

Meanwhile, despite the brouhaha in the Philippines, Sanofi continues to seek a phase 3 testing waiver in India for a potential launch, according to The Economic Times. A Sanofi representative didn't immediately confirm the report. A spokesperson in India reportedly told the publication Sanofi believes "our vaccine can make a difference in public health and therefore, the answer is yes," when asked about the waiver.

But India has its concerns, according to ET. A government official told the publication Dengvaxia does not provide "satisfactory" efficacy. 

RELATED: Takeda to build $106M vaccine plant for dengue vax push 

The controversy signals bad news for Dengvaxia, a product that once carried big sales expectations and one that took 20 years and $1.5 billion to develop. Public immunization campaigns were seen as key to the rollout, but so far only Brazil's Parana State and the Philippines have struck up such programs. Now, the experience in the Philippines will likely inform other countries' decision to invest in the shot.

Japan's Takeda is working on a potential rival that's in phase 3 testing and is confident enough in its vaccine that it pulled the trigger on a $106 million manufacturing plant in Germany.

Editor's note: An earlier version of this story stated that the Philippines was the only country conducting a large immunization campaign with Dengvaxia. Brazil's Paraná state is still using the vaccine.