New dengue vaccine could worsen disease in some people


Sanofi is taking a $120 million write-off on the setback, which dwarfs the amount the pharma giant has earned in its first anemic rounds of revenue - which fell far behind its own projections as well as the analysts who had been cheering them on.

As Reuters and several other news outlets have reported, France's Sanofi Pasteur released a statement that said a 6-year analysis of people who received the vaccine found more severe disease occurred in people who initially were naïve to the virus.

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. However, the highest risk of getting more severe disease has been observed in people infected for the second time by a different dengue virus.

The Sanofi label proposal will be reviewed by national regulatory agencies in each of the countries where the vaccine is registered or under registration.

Health chiefs in the Philippines have suspended the country's dengue immunisation programme after the vaccine's manufacturer admitted it could cause severe cases of the disease in some people.

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For the requested label change, Sanofi is asking doctors to consider whether it's likely an individual has been exposed to dengue, and if they haven't, to hold off.

The said vaccine was used in the department's dengue vaccination initiative that was launched in three highly endemic regions (Regions 3, 4-A, and NCR), with over 700,000 individuals receiving at least one dose of the vaccine.

Sanofi spent $1.5 billion over about 20 long years to develop its dengue vaccine, believing that it had a blockbuster product headed to a massive global market. Last year, it generated just €55 million in sales compared to the €200 million execs had anticipated.

The company said it expected the new findings to cost it £88m. The company said the indicated population for the vaccine, people 9 to 45 years old, are tougher to vaccinate as part of large programs than younger children or elderly people.

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