December 17, 2017

Health Risk: Philippines Suspends Sale Of Sanofi Dengue Vaccine

05 December 2017, 04:11 | Silvia Roy

WHO backs Philippines' suspension of Sanofi's Dengvaxia

WHO denies recommending Dengvaxia for nat'l immunization programs

They added that Dengvaxia immunized approximately 734,000 children aged 9 years and above in the country.

The Philippines has suspended the sale and distribution of the Dengue Tetravalent Vaccine, the drug locally registered as Dengvaxia, the Philippine Food and Drug Administration (FDA) said Tuesday.

A non-governmental organization (NGO) said it had received information that three children who were vaccinated with Dengvaxia in the Philippines had died and a senator said he was aware of two cases. It said its Strategic Advisory Group of Experts on Immunization would meet to review evidence next week.

"In order to protect the general public, the Food and Drug Administration (FDA) immediately directed Sanofi to suspend the sale/distribution/marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market, pending compliance with the directives of the FDA", the regulator said in a statement.

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The outcry of dengue in Southeast Asia and the confusion and concern regarding its vaccine in the Philippines is something people in and moving to the region must be wary of, as many may be rushing to protect themselves and their family from various exotic diseases.

Citing results of an assay test co-developed with the University of Pittsburgh, a Sanofi Pasteur India spokesperson told PTI, "For those not previously infected by dengue virus, the analysis found, in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection".

"In this group, all fully recovered with proper medical treatment". It was not immediately known many people have taken the vaccine, if it was part of any government immunization program or if any illnesses or deaths linked to the drug have been reported to the government.

Over 733,000 students from public schools in Metro Manila, Central Luzon and Calabarzon, nine years old and above, have received at least the first of three doses of the vaccine.

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According to Sanofi in Manila, 19 licences were granted for Dengvaxia, and it was launched in 11 countries, two of which - the Philippines and Brazil - had public vaccination programs.

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.

Brazil confirmed it already had recommended restricting use of the vaccine to those previously infected with dengue but had not suspended it entirely.

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