MANILA - The Philippine government will seek a refund and bring to court pharmaceutical giant Sanofi Pasteur over the dengue vaccine that spurred a health scare in the country, Health Secretary Francisco Duque said Thursday.
The Department of Health last week suspended the vaccination program after the company disclosed that its Dengvaxia vaccine may cause "more cases of severe disease" if given to those who have not had the mosquito-borne illness before.
"I’ll probably talk to them. I’ll tell them, ‘We have 1.5, 1.4 billion worth of remaining unusued vaccines. Balik yan, bayaran niyo kami,'" Duque told ANC's Headstart, adding that he will also ask for an indemnity fund from the firm if cases of previously vaccinated children manifesting severe symptoms are proven.
"Eventually that’s where it’s gonna go because eventually it’s the court of law that’s gonna decide insofar as the liability of Sanofi is concerned," he said when asked if the government will sue the drug maker.
Sanofi would be liable if it is found to have withheld material information "that would have changed the outcome of all of these problems and the decision-makers in the Department of Health in the previous administration," said Duque.
"It’s gonna get there. I’m sure it’s gonna get there, but the investigation will be able to produce the necessary pieces of evidence," he said.
The DOH will be attending the separate legislative inquiries at the Senate and the House of Representatives next week to present all documents pertinent to the investigation, he added.
The Philippines was the 1st country in Asia to approve the vaccine for individuals aged 9 to 45 years old in December 2015.
The government has since procured P3-billion worth of Dengvaxia intended for one million public school children in areas reported to have the highest incidence of dengue in 2015: in Metro Manila, Central Luzon, and CALABARZON regions.
The vaccine was to be administered in three phases at 6-month intervals beginning April 2016.
Sanofi Pasteur's statement last week was the first time the pharmaceutical company acknowledged that Dengvaxia should not be recommended to individuals if they have never been infected with the dengue virus. The manufacturer said it would ask health authorities to advise physicians and patients of the new information in countries where the drug has been approved.
Duque noted, however, that the firm only said that they have observed symptoms classified as Grade 1 and Grade 2 and that they never found cases classified as Grade 4; there was no mention of Grade 3 symptoms.
Duque said symptoms of Grade 1 dengue include high fever, headache, back ache, muscle pains, pain behind the eyes, and a bit of rash. Grade 2 includes evidence of bleeding, hematoma, nosebleed, and gum bleeding.
It elevates to Grade 3 if manifesting "heart symptoms," including thready pulse and hypotension, he said.
"They should have been more transparent or forthright in saying meron ba o wala. I’m doubting it because why didn’t they say? They comfortably said Grade 1, Grade 2 nakita namin; walang Grade 4," he said.
The DOH will be conducting mandatory surveillance of some 830,000 students vaccinated with Dengvaxia, he said, adding that it will last for 5 years even if the students do not display symptoms of dengue.
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