Sanofi expects $120 mln hit as dengue vaccine hits major snag

Sanofi expects $120 mln hit as dengue vaccine hits major snag

Sanofi expects $120 mln hit as dengue vaccine hits major snag

While Sanofi's Dengvaxia is the first-ever approved vaccine for dengue, scientists already recognised it was not ideal and did not protect equally against the four different types of the virus in clinical tests.

It warned that the vaccine may cause "more severe dengue cases" on those who may contract the disease for the first time. The analysis confirmed that the vaccine provided persistent protection against dengue fever in those who had prior infection, but in infection-naïve patients it was found that in the longer term, more cases of severe disease could occur following vaccination upon a subsequent dengue infection. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease).

Duque said Sanofi is using a classification-that identifies a case of dengue as "severe"- based on previous guidelines in 1996.

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Sanofi is proposing that national authorities update their prescribing information.

Health Secretary Francisco Duque 3rd said the DoH would review and consult with experts, key stakeholders and the World Health Organization (WHO) regarding Dengvaxia.

Before the current analysis, a research team past year found that the vaccine-if given to dengue-naïve individuals-"acts very much like a natural infection but without making recipients sick". "There was no reported severe case due to dengue vaccination in Brazil", he said.

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The minister said the government will profile all those who received the vaccination and heighten its surveillance mechanisms.

The DoH announcement came after receiving a preliminary briefing on November 29 from Sanofi Pasteur, the manufacturer of dengue vaccine Dengvaxia. The company said political and economic turmoil had an effect on the launch.

Dengvaxia is approved for marketing in 11 countries, mostly in Asia and Latin America, where dengue is a leading cause of serious illness and death among children.

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Some 500,000 patients each year require hospital treatment and about 12,500 of those die, according to the WHO.

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