Sanofi Taking $118.5M Charge, Seeks Restrictive Label for Dengue Vaccine

Dengvaxia_product_shots

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.

Health Secretary Francisco Duque III is hoping issues over the government's dengue immunization program will not deter the public from getting vaccinated for other diseases.

A new data analysis has concluded that if Dengvaxia is given to individuals who haven't been exposed to dengue, they could get more serious infections when they encounter the virus naturally.

More than 730,000 public school children aged 9 and above in three highly endemic Philippine regions have received at least the first dose of Dengvaxia, the first licensed dengue vaccine that is manufactured by Sanofi. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease). Dengue is an acute viral infection, which is transmitted through the bite of an Aedes aegypti mosquito and may result in death if left untreated.

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Sanofi Pasteur disclosed that a new analysis of long-term clinical trial data showed differences in Dengvaxia's performance based on prior dengue infection.

"As chair of the Senate Committee on Health, I intend to call for an investigation on the disturbing findings related to the dengue vaccine, Dengvaxia", he said.

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

"But then reviewing the guidelines, the ones classified by Sanofi [as severe] right now...most of the cases would not even fall under our current definition of severe", Suy explained.

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There are many factors that can lead to severe dengue infection. Because there are countless number of lives that have been saved from vaccine-preventable diseases.

For those who were not previously infected by the dengue virus, the analysis found that vaccination prevented severe illness for at least 30 months, Duque told reporters.

To that end, Sanofi said, it will ask regulatory agencies to update the prescribing information for Dengvaxia by adding a request that healthcare professionals evaluate the likelihood of prior dengue infection in patients before vaccination.

"The DOH and the Department of Education should also closely monitor the kids that were vaccinated and ensure that proper medical support will be provided to them", he added.

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