HEALTH Secretary Francisco Duque III on Thursday said he had ordered their Legal Department to file a civil case against Sanofi Pasteur after the French pharmaceutical giant rejected for the second time the Department of Health’s refund request for the used doses of the anti-dengue vaccine.
“I have forwarded the letter to the Legal Department and ordered that a civil suit be instituted against Sanofi Pasteur,” said Duque.
Duque was referring to the letter dated Feb. 15, 2018 from Thomas Triomphe, head of Asia-Pacific Region, Sanofi Pasteur, declining the DoH’s demand to refund the P1.6 billion for used doses of the anti-dengue vaccine and to set up an indemnification fund that would be used for the benefit of the Dengvaxia recipients.
As per the Terms of Reference on the procurement of the dengue vaccines, Duque said the DoH made it categorically clear that it intended to use the dengue vaccine in a school-based immunization program for students regardless of whether they have been infected by the dengue virus or not.
Duque said Sanofi Pasteur’s labeling did not qualify the recommended use or risk on the serostatus at baseline of the intended recipient of the vaccine.
Prior to the Nov. 29, 2017 announcement, he said Sanofi Pasteur never issued a warning nor precaution regarding the vaccine’s use among individuals who have had no prior dengue infection.
“It was only on this announcement that Sanofi Pasteur revealed that Dengvaxia poses a heightened risk of contracting severe dengue to seronegative individuals,” he said.
“It is regrettable that this crucial information was only made public by Sanofi Pasteur after the DoH has implemented the vaccine program to about 837,000 children,” he added.
Duque assured the general public it would exhaust all legal remedies against Sanofi Pasteur and would bring its misrepresentations to justice.
Sanofi said it responded to the DoH’s second request “that we refund the government for the used doses of Dengvaxia® and financially support an indemnification fund.”
“As we did in our previous reply to the DoH on 5 February, 2018, we respectfully declined both requests,” said Sanofi.
“We stand firmly behind our product. Refunding the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case. And at this time, there is also no known circumstance requiring indemnification,” it added.
Sanofi said its concern and empathy remained with any and all individuals and families that have been affected by these difficult circumstances.
Duque vowed to look after the needs of all vaccinated children and address the gaps observed in the rollout and implementation of the first dengue vaccine Dengvaxia.
“I would like to assure the parents and the public that investigations are currently under way,” said Duque.
“Should there be any DoH official who will be proven to have transgressed any law or deviate from standard operating procedures in relation to the purchase and implementation of the dengue vaccine, I will make sure that they will face justice,” Duque assured the parents of the Dengvaxia recipients.
The health chief emphasized his commitment to also unveil the truth with regard to the hasty implementation of the dengue vaccination program since March 2016.
He promised full cooperation and transparency in the submission of documents to the Department of Justice and both houses of Congress which are separately conducting investigation on the now suspended dengue vaccination program.
“I deny any accusation that I am obstructing justice. I am not protecting anyone, most especially those allegedly involved in the controversial implementation of the dengue immunization. I am also after the truth and I am for the correction of the deficiencies observed in the rollout of the program,” Duque said.
The dengue vaccination program of the DoH started with the administration of former secretary Janette Garin.
It was Duque who ordered the termination of the dengue mass vaccination program after Sanofi Pasteur, manufacturer of Dengvaxia, reported certain adverse effects following immunization.
“After Sanofi Pasteur made public certain adverse effects caused by the vaccine following immunization, I ordered the immediate termination of the program,” Duque said.
Amid ongoing investigations, the DoH is more focused on attending to the concerns of the more than 830,000 vaccine recipients and their families.