Sanofi denies anew DoH’s request

By CHARINA CLARISSE L. ECHALUCE

Pharmaceutical company Sanofi Pasteur has denied once again the requests of the Department of Health (DoH) for it to refund the Dengvaxia doses used by the government in its dengue immunization campaign and to put up an indemnification fund for the vaccinated children.

In a statement published yesterday it said, “As we did in our previous reply to the DoH on 5 February, 2018, we respectfully declined both requests.”

The company said agreeing to the requests would be tantamount to admitting Dengvaxia being ineffective.

Sanofi justified its rejection of the indemnification fund request saying there is “no known circumstance requiring indemnification.”

It further maintained, “Dengvaxia vaccination in the Philippines will provide a net reduction in dengue disease, including severe dengue and, thereby, reduce the overall public health burden with this disease.”

That said, it reminded the public there is not a single vaccine that gives 100 percent protection, adding “Dengvaxia, like all other vaccines, has never claimed 100 percent efficacy in its approved label.”

In any case, Sanofi said it is “willing to sit down with the Department of Health to find other ways we can assist their efforts to combat dengue in the Philippines and restoring public trust in vaccines.”

Vaccine controversy
On Nov. 29, last year, Sanofi Pasteur announced a “new finding” on Dengvaxia, which, at the time, was already being used in the government’s mass immunization program involving around 830,000 children.

“The analysis confirmed that Dengvaxia provides persistent protective benefit against dengue fever in those who had prior infection…. 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,” it said.
By December, Duque put on hold the government vaccination drive.

So far, the DoH has recorded 29 deaths among children who were given the vaccine.

DoH requests
On Jan. 12, the health department disclosed that it has asked Sanofi to refund the unused Dengvaxia and shoulder the testing of the vaccinated children.

In a letter sent to Thomas Triomphe, head of Sanofi Pasteur Asia Pacific, the DoH laid down its demand for Sanofi to refund in the amount of R1.4 billion which corresponds to the remaining unused vials of Dengvaxia.

In a separate letter, the health department requested the company to conduct serotesting of the vaccines using a newly developed test to determine their pre-vaccination status at no cost to the government.

Reimbursed doses
Sanofi has already reimbursed the unused Dengvaxia but clarified that agreeing to the DoH’s demand does not mean that their vaccine has a quality or safety issue.

“Our decision to reimburse for unused doses is not related to any safety or quality issue with Dengvaxia. Rather Sanofi Pasteur hopes that this decision will allow us to be able to work more openly and constructively with the DoH to address the negative tone towards the dengue vaccine in the Philippines today,” it explained.

“Sanofi Pasteur strongly believes that this tone is due to a misunderstanding of the benefits and risks associated with the dengue vaccine and a lack of awareness amongst the general public, particularly parents of vaccinated children, that the overall benefit of dengue vaccination remains positive in high endemic countries like the Philippines,” it added.

Sanofi, however, was urged later on to reimburse the used doses.