Sanofi Pasteur has turned down the Philippine Department of Health’s request to refund it for used dengue shots worth over $30 million, saying that would imply the vaccine doesn't work, when in fact, it does.
“Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” it said in a statement.
In response to Sanofi’s rejection, Philippine Senate President Aqulino Pimentel III, who previously also demanded a full refund, said Sanofi “should be sued,” maybe even in international courts, as quoted by the Inquirer.
Before the Philippines halted its mass dengue vaccination program in November over health concerns, more than 800,000 children had been immunized. The French drugmaker changed the vaccine's label to include new evidence indicating Dengvaxia’s could make symptoms worse for dengue-naïve people.
The country stopped the program in the face of public backlash accusing the government of moving too quickly to embrace the vaccine. As accusations erupted in the country, Sanofi made several financial concessions. It has already reimbursed the Philippine government for unused Dengvaxia doses worth about $23 million and agreed to cover for adverse events scientifically attributed to vaccination.
“[S]hould there be any case of injury due to dengue that has been demonstrated by credible scientific evidence to be causally related to vaccination, we will assume responsibility,” reaffirmed Sanofi in a statement.
But there’s apparently a limit to what Sanofi is willing to yield given there is no conclusive evidence that could question the shot's effectiveness. It already made clear its decision to return payments for unused shots was “not related to any safety or quality issue with Dengvaxia,” but a gesture of cooperation with local authorities.
The Philippine government and the company have different criteria of what merits a full refund. Department of Health Secretary Francisco Duque III previously said his agency made the demand “because the purported protection wasn’t felt, wasn’t there.” Sanofi, on the other hand, maintains that no deaths have been affirmatively linked to the vaccine, and in the statement said that “dengue vaccination in the Philippines will provide a net reduction in dengue disease.”
An expert panel from the University of the Philippines-Philippine General Hospital (UP-PGH) released findings last Friday from a study on deaths of 14 children after they were given the vaccine. “Causal association” was observed in three cases, two of which may be caused by vaccine failure, according to the experts. They admitted that “further testing of tissue samples and antibodies is also necessary” as it was still early to make a direct connection.
“The DOH acknowledges that there are still a lot of uncertainties on the Dengvaxia as it is a new vaccine but we are committed to continue the ongoing scientific investigation on other reported deaths and hospitalizations and future evidence that will emerge from implementation,” said the agency.
Citing the UP-PGH report as the recent no-linkage evidence, Sanofi also declined another request to provide for an indemnification fund to cover the hospitalization of those who got dengue after immunization. That cost is currently shouldered by the DOH.
Sanofi Pastuer said it would be willing to provide free doses of the vaccine should the Philippines decide to resume the community-based dengue vaccination program following the investigation.