Trouble mounts for Sanofi dengue vaccine over safety concerns


The Philippine government last week suspended its dengue immunization program for public school students after French drugmaker Sanofi announced possible risks if the Dengvaxia is administered to individuals not previously infected with dengue.

As per the guidelines of the U.S. Food and Drug Administration (FDA), Sanofi needed to conduct an information dissemination campaign.

Sanofi officials reported that there were no deaths reported due to the vaccine in the Philippines.

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Sanofi officials said on Monday in Manila that there had been no reported deaths related to the vaccine which was used to immunize almost 734,000 children aged 9 and over in the Philippines.

Brazilian health regulator Anvisa, in an emailed statement to Reuters, said it had not received any reports of vaccine recipients dying or falling more severely ill because of the drug. 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".

De Guzman also confirmed "there were no recipients of the Dengvaxia vaccine in Pangasinan" because of lower dengue cases a year ago compared with other places in the country. No cases in the most severe level were recorded, and all those stricken with dengue in the study have fully recovered, she said.

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A spokesperson for Sanofi Pasteur, which makes seasonal Influenza vaccines, said, "In India, we have seen the flu vaccination market double in the past few years, reaching one million doses last year".

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. But even recent more modest analysts' sales forecasts are now looking unattainable given the safety issue and clinical evidence revealing unequal protection against different strains of dengue.

The World Health Organization would review safety data on Dengvaxia by the end of December 2017.

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Dengue is a mosquito-borne viral infection found in tropical and subtropical climates worldwide.