Risa says Sanofi must pay over Dengvaxia mess; DOJ orders probe of PNoy gov’t’s P3.5-B vaccination drive

December 4, 2017 - 10:19 AM
In this photo: Sen. Ana Theresia "Risa" Hontiveros file photo released by her office.

(UPDATED — 11:27 a.m.) MANILA, Philippines — Sen. Ana Theresia “Risa” Hontiveros is urging the government to address the health threats posed by the anti-dengue vaccine developed by Sanofi Pasteur more systematically.

As the government announced an investigation into the vaccine mess on Monday, the lawmaker also said Sanofi must be responsible for the health needs of Filipino children who could suffer from the harmful effects of Dengvaxia, the world’s first anti-dengue vaccine.

In a statement issued Monday, Hontiveros, chairperson of the Senate Committee on Women and Children, said there must be a a “Luzon and Cebu-wide database to properly identify” the thousands of children affected by Dengvaxia.

“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,” the senator said.

“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,” she said.

“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 added.

Sanofi recently admitted that based on clinical tests, the vaccine that the French pharmaceutical giant developed could pose more risks for people who have not been infected by the dengue virus before immunization.

It was reported that the Philippines under the previous administration implemented a national school-based, anti-Dengue Immunization Program in 2016 using Dengvaxia.

Over 700,000 Grade 4 students (at least 9 years old) in Central Luzon, Calabarzon, and the National Capital Region have been given the dengue vaccine. Of the total number, health officials said that 70,000 were at risk.

Under the Duterte administration, the program was expanded in Region 7. Children aged nine to 14 in Cebu province were administered the first dose of the vaccine.

In a recent advisory, Sanofi said that new analysis of clinical data on Dengvaxia confirmed that for those not previously infected by 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.

DOJ orders probe

Also on Monday, Department of Justice Secretary Vitaliano Aguirre II ordered the National Bureau of Investigation to look into the “alleged danger to public health arising from the P3.5 billion antidengue vaccination drive” of the DOH.

Aguirre also directed the NBI to do “case buildup” and “if evidence so warrants…file appropriate charges” against those who would be proven liable for the mess.

The DOJ chief said the NBI must find out whether the government during the Aquino administration made the right decision in early 2016 to order P3.5-billion worth of Dengvaxia and had 733,000 children injected four months after the vaccine was manufactured by Sanofi.

Pag nagkakaroon ng ganitong imbestigasyon, tama ba ang pag-order kaagad ng ganito karaming vaccine na worth P3.5 billion? Na naturukan agad ang 733,000 children, tama ba ito, kahit apat buwan pa lang nama-manufacture ito?,” Aguirre told reporters.

Nagkaroon ng parang warning ‘yong Sanofi Pasteur, ‘yong manufacturer, sa government officials kaya ang susunod na tanong ay nasunod ba? O naiparating ba ito sa karamihan ng nasa DOH? Kung itong warning ng Sanofi ay talagang naibigay at kung naibigay, ito ba ay talagang naipatupad ng ating DOH officials,” the DOJ added.

[Did Sanofi Pasteur issue a warning and was this warning taken into consideration by government officials or did this warning reach the majority of DOH officials? Was this warning issued by Sanofi and if yes, did DOH officials make provisions for it]

‘Sanofi bears legal and ethical responsibility’

Hontiveros, who is also vice-chair of the Senate Committee on Health and Demography, said Sanofi “bears the legal and ethical responsibility to shoulder the health needs of the affected children and fully compensate their families.”

“Sanofi must be held responsible and the culpable health officials accountable. While vaccination and immunization are protective and essential elements of preventive health care, implementing an immunization program that could do more harm than good to our children is the height of negligence that could border on the criminal,” she said.

She also said that the Department of Health (DOH) “owes the public an explanation on how the controversial vaccine was acquired in the first place and why it failed to heed the apprehension and warnings of medical experts on its potential dangers.”