Court Orders Philippine Health Department to Answer Mothers’ Concerns about Dengue Vaccine

The Philippines’ highest court on Wednesday ordered the health department to answer a petition from parents seeking answers regarding risks associated with a school-based dengue vaccine immunization program that the government suspended last month.

The court gave Health Secretary Francisco Duque III and other government officials responsible for the public release of the vaccine, Dengvaxia, which was developed by French pharmaceutical giant Sanofi Pasteur, 10 days to reply.

The petition, representing at least 70 mothers of children injected with the potentially harmful vaccine, asked the court to compel Sanofi to fund long-term medical consultations and treatment for the estimated 830,000 grade school students vaccinated with Dengvaxia.

The government announced on Dec. 1, 2017, that it had suspended the vaccination program. It also ordered a halt to the marketing and selling of Dengvaxia after Sanofi admitted those injected with it risked having severe dengue if they had no prior infections.

The Philippines, a tropical Southeast Asian country, became the first country in the region where Dengvaxia was publicly released. Then-president Benigno Aquino III approved its release before he stepped down in 2016 and the vaccine was administered to children in public elementary schools.

The health department recently said 830,000 school children ages 9 and older were given the drug, a revision from an earlier estimate of 740,000.

Last month, Aquino defended his government’s decision to approve the vaccine during an appearance before a Senate committee investigating Dengvaxia. At that time, Aquino said no one had warned him about the dangers of the vaccine as the country struggled with the rise of the mosquito-borne disease.

He said he acted in good faith when the government approved the release of 3.5 billion pesos (U.S. $69 million) to purchase the drug, which Sanofi had advertised as the world’s first approved anti-dengue vaccine.

Aquino had found an ally in President Rodrigo Duterte, who said he supported his predecessor’s approval of the drug meant to address dengue, which infects about 200,000 Filipino annually.

Petition

The mothers asked the Supreme Court to order the health department to publicly release its report on Dengvaxia and for those injected with the vaccine be given “free medical services” until such time that scientific experts declared the threat of the vaccine has been minimized.

Duque said a task force had been created and was monitoring all children vaccinated. In addition, a panel of experts had been set up to conduct additional tests.

An independent review of medical charts of children “who may have experience adverse effects or died following immunization” is being undertaken to determine if the deaths were directly linked to the drug, according to the health department.

Duque also appealed to the public to be patient as the justice department carries out its own investigation to determine any criminal culpability related to the purchase of Dengvaxia and allow investigators to carry out their work free of criticism and accusations.

No clear mechanisms

Eleanor Jara, co-convenor of the advocacy group Coalition for People’s Right to Health, said the public should demand full accountability from both the French pharma giant and the government.

“Complete accountability must be pursued on Sanofi and all current and former government officials who connived in the planning and implementation of the program,” Jara said, arguing children injected with the drug must be “accorded free medical health services for a lifetime.”

“We cannot blame the public if they raise suspicions on the possibility that some national officials profiteering from the transaction,” she said, calling the previous government “overzealous” in closing the deal with Sanofi.

Jara said her group, which was not party to the court petition, was meeting with lawyers to determine potential legal avenues. She added the government has not gone to the grass root level in communities where children were vaccinated to educate people about the potential dangers.

“There remains no clear mechanisms and structures set up to support Dengvaxia vaccinated individuals,” she said.

Felipe Villamor in Manila contributed to this report.