Sanofi rejects refund, indemnity
Sanofi Pasteur, the French pharmaceutical firm behind Dengvaxia, rejected yesterday an appeal from the Philippine government to refund about 11.8 billion in payment for used doses of its controversial anti-dengue vaccine and put up an indemnity fund for those administered with the vaccine, who later developed serious or fatal cases of dengue.
“This morning Sanofi Pasteur responded to the Department of Health’s (DOH’s) request that we refund the government for the used doses of Dengvaxia
and financially support an indemnification fund. In our letter to the Department of Health we respectfully declined both requests,” the Sanofi said in an official statement sent to the press.
At yesterday’s joint House panel hearing on the Dengvaxia mess, Sanofi Asia-Pacific head Thomas Triomphe confirmed that they have declined the requests from DOH Secretary Francisco Duque III.
“The reason why (we are declining) is because doing so would imply that the product is ineffective, [and] does not provide the effect provided, which actually is not the case,” Triomphe told the joint Committees on Good Government and Public Accountability and Health conducting the probe.
Last November, Sanofi announced new findings on its Dengvaxia vaccine. It stated: “For those not previously infected by dengue virus, however, the analysis found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection.”
This has raised a furor over the government’s mass immunization program which was implemented since 2016 at the time of the Aquino Administration in which around 830,000 children were vaccinated.
“As you know today, by using Dengvaxia in the Philippines... will make sure that there are less dengue cases than not using Dengvaxia. We stand behind the efficacy and safety of the product. And that is why we are not reimbursing the already used doses,” Triomphe told legislators, as he explained further the his firm’s refusal to refund 11.8billion worth of used Dengvaxia vaccines.
Sanofi also explained why it had decided earlier to reimburse to the Philippine government the unused doses of Dengvaxia. “When Sanofi Pasteur agreed to reimburse the Philippine government for unused doses of Dengvaxia, we did so to show our continued commitment to cooperate with the Department of Health in ensuring the best possible health outcomes for the people of the Philippines. This decision was not due to any safety or quality concerns about the Dengvaxia vaccine,” it said in a statement.
Reimbursement received
Duque told congressmen that they have properly received the pharmaceutical agency’s earlier reimbursement of 11.16 billion for the unused Dengvaxia vaccines.
He said the amount has been reverted to the national treasury.
Likewise, Duque said the unused 1500 million-plus that had been allocated for the supposed anti-dengue immunization program had also been returned to government coffers.
The Philippines became the first country in the world to launch in April, 2016 a public inoculation plan against dengue using Dengvaxia, but it was stopped following the new findings published by Sanofi.
Since then, 29 deaths among those vaccinated have been recorded.
Free doses
Still, Sanofi said it would provide free doses to children who previously received at least a dose of the three-dose vaccination program.
“If the Department of Health decides to reinstate the community-based dengue vaccination program following a more complete evaluation of the new data on the vaccine, Sanofi Pasteur would be willing to provide new doses of the vaccine free of charge. These new doses would allow people who previously received one or two doses of the vaccine in the public program to complete the three-dose schedule and, thus, have the opportunity to benefit from the full potential of Dengvaxia’s ability to protect against dengue,” the company assured.
Meanwhile, it explained that it will not support an indemnification fund as there are no safety concerns about the vaccine.
“As for the indemnification fund, there are no safety or quality concerns about the Dengvaxia vaccine. The UP-PGH expert panel declared again on Friday that there is no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths. Sanofi Pasteur has always followed the highest ethical standards and should there be any case of injury due to dengue that has been demonstrated by credible scientific evidence to be causally related to vaccination, we will assume responsibility,” it said.
‘Blacklist Sanofi’
Senior administration congressmen yesterday called on the DOH to initiate immediately the process of blacklisting Sanofi from conducting future pharmaceutical sales with the government.
This developed as opposition Rep. Lito Atienza (Buhay Partlylist) demanded the presence of former Budget Secretary Florencio Abad and representatives of former President Benigno Aquino III in the next hearing of the Dengvaxia probe.
Ako Bicol Rep. Rodel Batocabe aired the appeal as he lashed at the French pharmaceutical firm for rejecting demands for the refund of payment made by government in the purchase of the vaccines.(With a report from Ben R. Rosario)