‘Where is the Proof Dengvaxia Vaccine Linked to Philippines Deaths’ Says Sanofi

Dengvaxia vaccine may make future dengue episodes more severe

Filipino children

Sanofi Pasteur said ‘there’s no evidence of a link between the world’s first dengue vaccine and children’s deaths in the Philippines,’ reported the AP.

Paris-based Sanofi said on February 7, 2018, that ‘it lost 19 million euros in the fourth quarter on the (Dengvaxia) vaccine, as it bought back unused medicines.’

Sanofi’s CEO Olivier Brandicourt said, “we have absolutely no evidence that the vaccine has been linked to any deaths.”

On November 29, 2017, Sanofi announced that it would ask health authorities to update information provided to physicians and patients on its dengue vaccine Dengvaxia® in countries where it is approved.

The Dengvaxia vaccine is not approved in the USA.

This request was based on a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection, said Sanofi.

The company said a new analysis shows that, for dengue-naive recipients, the vaccine makes future dengue episodes more severe, and has changed the vaccine's label to include this new evidence.

Philippines health authorities say the deaths of three children may have “causal association” to the vaccine.

On January 26, 2018, the Philippines government requested a full refund from Sanofi.

Sanofi turned down the Philippine Department of Health’s request to refund saying ‘that would imply the vaccine doesn't work, when in fact, it does.’

“Agreeing to refund the used doses of Dengvaxia would imply that the vaccine is ineffective, which is not the case,” Sanofi said in a statement.

In response to Sanofi’s refund rejection, Philippine Senate President Aqulino Pimentel III, said Sanofi “should be sued,” maybe even in international courts, as quoted by The Inquirer.

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Prior to the Philippines halting a dengue vaccination program in November 2017, more than 800,000 children had been immunized.

The University of the Philippines-Philippine General Hospital (UP-PGH) issued an initial report has found a "causal association" between three deaths and the vaccine.

A Sanofi spokesperson said the report confirmed: "that there is currently no evidence directly linking the Dengvaxia vaccine to any of the 14 deaths."

"In Dengvaxia clinical trials conducted over more than a decade and the over one million doses of the vaccine administered, no deaths related to the vaccine have been reported to us," the company's spokesperson added.

Sanofi said it would be willing to provide free doses of the vaccine should the Philippines decide to resume the community-based dengue vaccination program following the investigation.

Dengue is a mosquito-borne virus that each year infects an estimated 390 million people worldwide. Dengue fever is common in many parts of the tropics and about half the world's population is at risk of infection, reports the World Health Organization (WHO).

Dengue is caused by any of four related viruses, termed serotypes DEN-1, DEN-2, DEN-3, and DEN-4.

A person exposed to one dengue virus type gains immunity to that type, but not to the other three.

In fact, a second infection with a virus type that differs from the first can lead to a more severe course of the disease, says the WHO.

Dengue is transmitted to people by Aedes aegypti mosquitoes. The same mosquitoes that carry the Zika virus.