STATEMENT ON LETTER FROM SANOFI PASTEUR DECLINING DOH DEMAND FOR REFUND AND INDEMNITY FUND FOR DENGVAXIA RECIPIENTS

The Department of Health on Monday received the letter dated February 15, 2018 from Mr. Thomas Triomphe, head of Asia Pacific Region, Sanofi Pasteur, declining the DOH's demand to refund the used doses of Dengvaxia in the amount of Php1.6 billion and to set up an indemnification fund that will be used for the benefit of the Dengvaxia recipients.

I have forwarded the letter to the Legal Department and ordered that a civil suit be instituted against Sanofi Pasteur.

The DOH maintains that as per the Terms of Reference on the procurement of the dengue vaccines, the DOH made it categorically clear that it intends 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. 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 November 29, 2017 announcement, Sanofi Pasteur never issued a warning or 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.

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.

The DOH assures the general public that it will exhaust all legal remedies against Sanofi Pasteur and will bring its misrepresentations to justice.


FRANCISCO T. DUQUE III. M.D., MSc.
Secretary of Health