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Health chief looks into Sanofi liability Sanofi’s liability

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HEALTH Secretary Francisco Duque III on Monday said the manufacturer of Dengvaxia may be charged for releasing the anti-dengue vaccine after it was revealed it can cause severe ailments to children who have not been infected by the virus before vaccination.

“It’s possible there’s liability, but I have asked the Department of Health legal services to study the contract and their undertakings, because every contract has stipulations,” Duque said.

French drug manufacturer Sanofi Pasteur issued a warning last week that those who have not had dengue before could suffer a more severe form if they were immunized with Dengvaxia.

Sanofi said that new analysis of clinical data on Dengvaxia confirmed that for those not previously infected by the dengue virus, more cases of severe disease could occur following vaccination upon a subsequent dengue infection. The vaccine only provides persistent protective benefit against dengue fever in those who had prior infection, Sanofi said.

Duque said it was also possible that Sanofi held back data that showed the adverse effects of Dengvaxia, but no solid conclusions could be made before an investigation.

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An estimated 733,000 children in public elementary schools aged 9 and above residing in Regions III, IV-A, and the National Capital Region were administered Dengvaxia in three rounds over the past year.

Duque said 10 to 20 percent of these students have not contracted dengue prior to inoculation.

Duque said it was too early to say if the previous administration had rushed its decision to buy the vaccine until all documents pertaining to it are reviewed.

A total of P3.5 billion was spent to acquire the three doses of Dengvaxia used in the suspended dengue immunization program.

In a news conference Monday, Sanofi officials clarified that the vaccine does not cause “severe dengue.” 

Akbayan Senator Risa Hontiveros, who chairs the Senate committee on women and children, on Monday called on the government to create a “Luzon and Cebu-wide database” to properly identify the thousands of children affected by an anti-dengue vaccine.

“Our primary concern right now should be the health and welfare of all those children exposed to unnecessary risk as a result of the immunization program. We need a database to identify the 70,000 affected children and know where they are exactly located in order for the government to keep track of their health and prepare the needed resources and logistics that will allow for quick and appropriate medical responses, if needed. This is our most urgent task. Laxity is not an option. We are racing against time. We must protect and ensure the good health of our children,” Hontiveros said. 

Reps. Emmi de Jesus and Arlene Brosas of Gabriela Party-list will file a resolution calling for an investigation of the vaccine deal.

“Over 70,000 Filipino children are at risk of more severe symptoms due to the Dengvaxia vaccine, and this is not a joke. This is a potential public health crisis that should not be downplayed and dismissed by the Department of Health, Malacañang and Sanofi Pasteur by blanket assurances,” De Jesus said. 

“It is reprehensible that the Health Department implemented the immunization program in 2016 based only on the apparent big pharma lobbying and ahead of any completed clinical study on the vaccine’s safety,” she added. 

Justice Secretary Vitaliano Aguirre, meanwhile, has asked the National Bureau of Investigation (NBI) to investigate the culpability of former President Benigno Aquino III, former Health secretary Janette Garin and other health officials responsible for the implementation of the P3.5-billion dengue vaccine project.

“The National Bureau of Investigation through Director General Dante A. Glerran is hereby directed and granted authority to conduct investigation and case build up over the alleged danger to public health arising from the P3.5-billion anti-dengue vaccination drive of the [DoH] and Sanofi Pasteur and if evidence so warrants to file appropriate charges,” Aguirre said in a memo.

 Agurre said Aquino, who gave the go-signal for the DoH to implement the vaccination program in 2016, would be among those investigated.

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