Sanofi updates information on dengue vaccine

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But manufacturer Sanofi Pasteur admitted on Wednesday that new analysis of clinical data had found Dengvaxia can cause more severe cases of dengue in the longer term among people who had not previously contracted the infection.

In September, a data analysis entitled "Benefits and risks of the Sanofi-Pasteur dengue vaccine: Modeling optimal deployment" revealed that while the medicine worked efficiently with patients who have been infected with dengue fever prior to vaccination, those who had not previously had the disease and were administered with Dengvaxia could develop more cases of severe disease.

For those not previously infected by the dengue virus, analysis found vaccination prevented severe illness for at least 30 months, Mr Duque said.

Before the current analysis, a research team a year ago found that the vaccine-if given to dengue-naïve individuals-"acts very much like a natural infection but without making recipients sick".

Still, the vaccine can provide worthwhile protection for those who have already been exposed to the virus, and so Sanofi is asking regulators to change the vaccine's label based on the findings.

Duque said over 733,000 children from Central Luzon, CALABARZON and Metro Manila were vaccinated with Dengvaxia since 2016.

Health spokesperson Lyndon Lee Suy said "It's totally different from the current guidelines of the WHO".

"The latest medical report issued by Sanofi is deeply shocking and disturbing especially to any parent whose children have received the vaccine", she said.

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The health department, nonetheless, is reviewing its contract with Sanofi.

Currently, DOH has a 1.4 billion stockpile of the vaccine.

The minister said the government will profile all those who received the vaccination and heighten its surveillance mechanisms. We want their official definition of what is "severe".

Duque said Dengvaxia was the first dengue vaccine to be licensed after being approved in Mexico in December 2015.

Dengvaxia was developed by Sanofi after 25 clinical studies in 15 countries over 20 years.

The DOH, on the other hand, said the pharmaceutical company must clarify their definition of "severe dengue".

"Put on hold muna tayo sa ating vaccination sa dengue", Health Secretary Francisco Duque III said in a media briefing on Friday.

The Food and Drug Administration will also halt the commercial sale of Dengvaxia in the country until Sanofi replaces its packaging with one that states a new warning.

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