Health Risk: Philippines Suspends Sale Of Sanofi Dengue Vaccine

Henrietta Brewer
December 5, 2017

The Philippine Department of Health put on hold its 3.5 billion peso ($69.5 million) public dengue immunisation drive launched previous year - the world's first such public programme - after the study was released last week.

Sanofi Pasteur, the vaccines division of Sanofi, today said Food and Drug Administration of Philippines has granted marketing approval to its Dengvaxia vaccine to be licensed for the prevention of dengue in Asia.

As per the guidelines of the U.S. Food and Drug Administration (FDA), Sanofi needed to conduct an information dissemination campaign. The WHO Country Office said this position paper was "based on recommendations of the Strategic Group of Experts on Immunisation which met and published preliminary advice in mid-April 2016".

On Nov. 29, the company disclosed that it would ask global health regulators to restrict use of its much-touted dengue vaccine to only people who have previously been infected by the virus.

Health officials say they vaccinated 730,000 children in the Philippines, 9 and up. No cases in the most severe level were recorded, and all those stricken with dengue in the study have fully recovered, she said.

As of November 2017, about 733,713 Filipino children have been given the anti-dengue vaccine.

The trial, known as Cdiffense, tested Sanofi's experimental toxoid vaccine in older patients who are at higher risk of infection from the bacteria.

The scare surrounding the disease, which upon infection can progress to progress to the deadly dengue haemorrhagic fever or dengue shock syndrome, has led scientists to develop the world's first ever dengue fever vaccine called the Dengvaxia vaccine.

The recent findings outline that sales forecasts may not be reached over the safety issues and clinical proofs that show unequal protection against various strains of dengue.

The WHO said on Monday it hoped to review safety data this month on Sanofi's dengue vaccine which the company said was approved in 19 countries and launched in 11.

"The WHO position paper did not include a recommendation to countries to introduce the dengue vaccine into their national immunization programs".

Dengue is a mosquito-borne tropical disease that kills about 20,000 people a year and infects hundreds of millions.

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