Sanofi’s Dengvaxia facing headwinds citing safety concerns

Sanofi has clarified, it has not received any evidence of heightened incidence of severe dengue in vaccinated individuals in real world incidents.

Sanofi’s dengue vaccine has got itself into a spot of trouble with the World Health Organization calling for reviews of the safety data for the dengue vaccine.

Separately, the Philippines has also ordered an investigation an investigation into a massive immunization program following the drugmaker’s statement that the disease could worsen in a few stray cases.

Safety concerns revolve around increased risk to people who have not been previously exposed to the dengue virus prior to vaccination with Dengvaxia.

Sanofi SA has tried to allay those concerns saying “the vast majority of those vaccinated to date live in high endemic settings and, therefore, will have had a prior dengue infection before vaccination.”

Sanofi’s Dengvaxia is the first approved dengue vaccine in the world and is expected to bring in $1 billion in annual sales. However this forecast may get skewed by recent safety and clinical evidences which reveal unequal protection against different strains of the dengue virus.

Sanofi said, the vaccine has so far been approved in nineteen countries since its launch in 2011. The bulk of the vaccinations have occurred in the Philippines through a government immunization program involving more than 730,000 children; vaccination programs have also been held in Brazil, where there has been widespread incidents of the decease in the past few years.

In mid-2016, Who had issued a report recommending the vaccine to only those who had survived a previous dengue infection.

Brazil has confirmed that it has restricted the vaccine to only those who have been previously infected with the dengue virus, but has not suspended its vaccination program entirely.

Brazil’s health regulator, Anvisa stated, it has not received any reports of vaccine recipients dying or falling severely ill because of the Sanofi’s Dengvaxia.

Sanofi has underscored the fact that it has not received any evidence of increased incidence of severe dengue in vaccinated individuals in the real world experience. As per the drugmaker, the long term safety evaluation of Dengvaxia has shown significantly fewer hospitalizations due to dengue in vaccinated people over 9 years old compared with those who had not been vaccinated.

Singapore’s Health Sciences Authority said last week it was working with Sanofi to strengthen risk warnings on the drug’s packaging.

Sanofi spent 20 years developing the world’s first dengue vaccine at a cost of around 1.5 billion euros ($1.78 billion).

European health regulators are currently reviewing Sanofi’s Dengvaxia.

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