FRENCH PHARMACEUTICAL giant Sanofi on Monday told the Philippines it would not refund the cost of used doses of a dengue vaccine after the vaccination program was suspended over health concerns.

The Philippines had asked Sanofi to refund a total P3.2 billion ($62 million) spent on the public vaccination program after the company said the vaccine could worsen symptoms in some cases, Health Secretary Francisco T. Duque III said.

Sanofi last month agreed to reimburse the Philippine government P1.6 billion ($31 million) for leftover doses of Dengvaxia. But it said Monday it would not pay for doses that were already used.

“Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” Sanofi Pasteur said in a statement.

The refund offered for unused Dengvaxia doses was not due to safety or quality concerns but simply to show that the company was cooperating with Manila, it added.

For his part, the company’s Asia-Pacific head Thomas Triomphe said at a congressional inquiry on Monday: “With all due respect, we decided to refuse the proposal of the secretary of health to actually reimburse the used doses. The reason why, is because doing so would imply that the product as ineffective, does not provide the effect provided, which actually is not the case.”

He added: “As you know very well, today, by using Dengvaxia in the Philippines, a highly endemic country, using Dengvaxia will make sure that there are less dengue cases than not using Dengvaxia. And we stand, as previously mentioned, behind the safety and efficacy of the product, and that is why we are not reimbursing the doses.”

LEGAL OPTION
Mr. Duque said a legal step is an “option.”

“(Legal action is) an option, your honor, but we will defer to our task force…which I put together in December. So given this information, we will look at our other options available, your honor,” Mr. Duque said in answer to Surigao del Sur Representative Johnny Ty Pimentel, who heads the House good government and public accountability committee, co-leading the inquiry with the health committee.

Dengue or hemorrhagic fever, the world’s most common mosquito-borne virus, infects an estimated 390 million people in more than 120 countries each year, killing more than 25,000, according to the World Health Organization.

The Philippines has one of the highest dengue fatality rates in the world, with 732 deaths last year, the country’s Health department said.

The country launched the world’s first public dengue vaccination program in 2016, but suspended it and stopped the sale of Dengvaxia in December after Sanofi warned that the injections could make symptoms worse for vaccinated people who contracted the disease for the first time.

The announcement caused panic among parents of some 830,000 schoolchildren vaccinated under the public dengue immunization program in 2016 and 2017, the Health department said.

The government is also investigating Dengvaxia’s alleged role in the deaths of at least 14 vaccinated children.

Health officials on Friday said public immunization programs for other preventable diseases were suffering in the wake of the panic, with many parents wary of getting their children vaccinated following the controversy.

However, Sanofi has insisted that no one has been proven to have died from Dengvaxia.

On Monday, Sanofi rejected a separate health department request to set up an indemnification fund to cover the hospitalization and treatment for vaccinated children who contract severe dengue.

“Should 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,” it said.

In her testimony, Food and Drug Administration (FDA) field chief Melody Zamudio said Dengvaxia is not registered with the French FDA.

“There’s no registration in the France FDA and it is also… in case the product is not registered in the country of origin, we require this proof that it is only for export. And in this case, it is not registered in France,” Ms. Zamudio said.

But she also noted that there are medicines approved even without the registration in the source country if they have a certificate of good manufacturing practice. She added that other requirements, including the “requirements of quality, requirements of safety, [and] requirements of efficacy… [have] been satisfied.”

Mr. Triomphe said Dengvaxia’s registration is pending with the European Medicines Agency (EMA). He said: “Every single national agenc(y) decide(s) on its own, when to license or not a product. We have nothing to do in this process….Secondly, as you probably know, Dengvaxia is licensed for use for people in endemic countries.”

‘LEAVE IT TO THE EXPERTS’
For his part, Senator Joseph Victor G. Ejercito urged the Public Attorney’s Office (PAO) to coordinate with the expert panel at the University of the Philippines — Philippine General Hospital (UP-PGH) on its investigation regarding the deaths of Dengvaxia-vaccinated children, saying the latter have the expertise on this matter.

“My appeal to the PAO — I’m not saying they should stop investigating — but whatever information they have, they have to coordinate with the UP-PGH because they are the experts. They are the people who know and understand the problem,” Mr. Ejercito said in an interview with reporters on Monday.

Mr. Duque himself had urged the same. “Let’s leave it to the experts, to the doctors, to the pediatrician to manage this. This is not a difficult case to manage,” he said. — AFP with reports by Minde Nyl R. dela Cruz, Camille A. Aguinaldo and philstar.com