French pharmaceutical giant Sanofi Pasteur has declined the demand of the Philippine government to fully refund the P3 billion spent on its anti-dengue vaccine, Dengvaxia.
Sanofi said it wrote a letter to the Department of Health (DOH) and respectfully rejected to refund the Philippine government for the used doses of Dengvaxia and support an indemnification fund.
“Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” Sanofi explained in a statement.
Sanofi stressed that when it 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 added.
Sanofi paid an initial P1.16 billion refund last month for unused vaccine doses.
“The data remains quite clear that, in absolute terms, dengue vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden associated with this disease,” Sanofi asserted.
As for the indemnification fund, Sanofi said “there are no safety or quality concerns” about Dengvaxia.
“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,” Sanofi said.
It added that if the DOH decides to reinstate the community-based dengue vaccination program following a more complete evaluation of the new data on the vaccine, Sanofi 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 3-dose schedule and, thus, have the opportunity to benefit from the full potential of Dengvaxia’s ability to protect against dengue,” Sanofi said.
“Sanofi Pasteur will continue to work with the Philippines regulatory authorities, Department of Health and all other health and community organizations to collaborate and cooperate in finding the best solution for integrated dengue prevention in the Philippines. We look forward to a continued dialogue with the Philippine government,” it added. /kga