Gov’t to sue maker of dengue vaccine

LIABILITY The government intends to sue Sanofi Pasteur over the use of the drugmaker’s Dengvaxia vaccine in an immunization program that was halted after the company said the drug
could lead to severe infections in some cases. —LYN RILLON

The Department of Health (DOH) is looking into the case of a 12-year-old child who contracted dengue despite being immunized with a vaccine made by the French pharmaceutical company Sanofi Pasteur.

The government intends to sue Sanofi after authorities suspended the company’s Dengvaxia vaccine in response to its own warning that the drug could lead to severe infections in some cases, Health Secretary Francisco Duque III said on Thursday.

Report from province

Citing a report he had received from a hospital in Pampanga province, Duque said the child received Dengvaxia three times: in March 2016, October 2016 and August 2017.

“Sanofi claims the vaccine gives protection for more or less 30 months but as we have seen, it’s only 20 months,” Duque said in an interview on Radyo Inquirer.

Duque declined to disclose the child’s identity for privacy.

“The child received protection but after the child was bitten [by a mosquito], the child showed symptoms of dengue. The doctors said it was severe dengue with hypertension bradycardia,” Duque said in Filipino.

The child, who had been confined at JB Lingad Memorial Regional Hospital in the City of San Fernando, has since recovered and health officials are looking into the child’s medical record.

Immunization drive halted

The government paid Sanofi P3.5 billion for Dengvaxia supplies for its immunization program.

But the DOH suspended the program on Friday, two days after Sanofi announced that Dengvaxia could worsen symptoms for vaccinated people who contracted the disease for the first time.

On Monday, the Food and Drug Administration (FDA) ordered Sanofi to stop the sale, distribution and marketing of Dengvaxia in the Philippines until the company could comply with Philippine regulations.

“Eventually, it’s the court of law that is going to decide in so far as the liability of Sanofi is concerned,” Duque said in a television interview on Thursday.

He said more than 830,000 schoolchildren had received at least one dose of the vaccine.

Previously, the DOH said more than 733,000 schoolchildren had been vaccinated.

‘Confusing’ statements

Sanofi’s announcement last week caused great concern in the Philippines, where the mosquito-borne disease is extremely prevalent.

The company on Monday sought to ease concerns, saying Dengvaxia would not cause anyone who was immunized to die and would not cause a dengue infection.

But Duque said on Thursday that Sanofi’s recent statements on Dengvaxia were “confusing.”

He said he may ask Sanofi to refund P1.4 billion worth of unused Dengvaxia supplies.

‘Indemnity fund’

Duque added that the government might also demand Sanofi set up an “indemnity fund” to cover the hospitalization cost for children vaccinated under the public immunization program who would fall ill.

Sanofi was not immediately available for comment on Duque’s remarks.

Asked if the government would sue Sanofi if allegations of a lack of transparency were proved, Duque said: “I’m sure it’s going to get there.”

He added: “If it’s found out that [Sanofi] withheld material information that would have changed the outcome of all of these problems and the decision makers of the Department of Health in the previous administration, then they are liable.”

Duque said congressional hearings into the controversy would start next week. —WITH A REPORT FROM AFP