No refund for used dengue vaccine, Sanofi tells Manila

Refund would imply vaccine is ineffective, which isn't the case, says pharma giant

Sanofi Pasteur's Asia Pacific head Thomas Triomphe (below) said at a congressional hearing in Manila yesterday that there is no evidence linking Dengvaxia to any of the 14 deaths. Use of the vaccine was approved by former health secretary Janette Gar
Sanofi Pasteur's Asia Pacific head Thomas Triomphe said at a congressional hearing in Manila yesterday that there is no evidence linking Dengvaxia to any of the 14 deaths. Use of the vaccine was approved by former health secretary Janette Garin (above), who was seated beside current Health Secretary Francisco Duque at the hearing. PHOTO: AGENCE FRANCE-PRESSE
Sanofi Pasteur's Asia Pacific head Thomas Triomphe (below) said at a congressional hearing in Manila yesterday that there is no evidence linking Dengvaxia to any of the 14 deaths. Use of the vaccine was approved by former health secretary Janette Gar
Sanofi Pasteur's Asia Pacific head Thomas Triomphe (above) said at a congressional hearing in Manila yesterday that there is no evidence linking Dengvaxia to any of the 14 deaths. Use of the vaccine was approved by former health secretary Janette Garin, who was seated beside current Health Secretary Francisco Duque at the hearing. PHOTO: AGENCE FRANCE-PRESSE

French pharmaceutical giant Sanofi Pasteur yesterday declined to refund the Philippines for used vials of Dengvaxia, its controversial vaccine against the mosquito-borne dengue disease, worth about 1.6 billion pesos (S$40.9 million).

Sanofi said doing so "would imply that the vaccine is ineffective, which is not the case".

The vaccine sparked public furore here after Sanofi revealed that inoculating children who had not had dengue could lead to them getting a more severe strain of the disease.

The announcement caused panic among parents of about 830,000 schoolchildren vaccinated under the public dengue immunisation programme in 2016 and last year.

Fears were stoked even further following claims that at least 14 children died soon after they were inoculated.

"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 added.

The company had already paid the Philippines 1.16 billion pesos for unused doses of Dengvaxia.

The refund was not due to safety or quality concerns, but merely to show it was cooperating with the health department, it said.

Health officials said public immunisation programmes for other preventable diseases were suffering in the wake of the panic.

"Every illness now is being attributed to Dengvaxia. This is not helping the situation," Health Secretary Francisco Duque said yesterday.

Dengue, the world's most common mosquito-borne virus, infects an estimated 390 million people in more than 120 countries each year, killing more than 25,000, according to the World Health Organisation.

The Philippines has one of the highest dengue fatality rates in the world, with 732 deaths last year.

It launched the world's first public dengue vaccination programme in 2016, but suspended it and stopped the sale of Dengvaxia last December after Sanofi warned that the injections could make symptoms worse for those who contracted the disease for the first time.

Sanofi shot down calls for it to set up an "indemnity fund" to cover the hospitalisation and treatment of children who could contract severe dengue as a result.

"There has been no evidence linking Dengvaxia to any of the 14 deaths. We strongly stand behind the record of safety and efficacy of this product, which is why it's still being used in other countries where it is licensed," Sanofi's Asia-Pacific head Thomas Triomphe said at a congressional hearing in Manila yesterday.

An independent panel of experts from the Philippine General Hospital found only three of these deaths had "causal association" with Dengvaxia, and that two of these three could have been due to "vaccine failure".

Six died of other causes, three were considered "coincidental", and there was not enough information on the remaining two.

But the Public Attorney's Office (PAO), tasked by the Justice Department to investigate the vaccine mess, reported seeing a "bleeding pattern" in the 14 children it autopsied, and suggested these could have been caused by Dengvaxia.

Mr Duque said further tests were needed to determine whether Sanofi could be held liable.

The PAO has filed a civil case for "grave misconduct" and "gross negligence" against former health secretary Janette Garin, who approved the use of Dengvaxia, and officials of Sanofi.

It is seeking about 4 million pesos in damages on behalf of the parents of 10-year-old Anjelica Pestilos, one of the 14 children who died of dengue despite being inoculated.

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A version of this article appeared in the print edition of The Straits Times on February 06, 2018, with the headline No refund for used dengue vaccine, Sanofi tells Manila. Subscribe