Published: Fri, December 01, 2017
Medicine | By Earnest Bishop

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

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

Sanofi said Thursday its dengue vaccine might worsen the disease for those who have not been previously exposed to the dengue virus, but safe for those who had a prior infection.

"In the light of this new analysis, the DOH (Department of Health) will place the dengue vaccination program on hold while review and consultation is ongoing with experts, key stakeholders, and the WHO (World Health Organization)", Health Secretary Francisco Duque said. The Department of Health launched the 3.5 billion peso ($69.5 million or 8 billion yen) program past year.

Drugmaker Sanofi says that its dengue vaccine, the world's first, should only be given to people who have previously been sickened by the virus, according to new long-term data. Vaccination should only be recommended when the potential benefits outweigh the potential risks (in countries with high burden of dengue disease).

Sanofi is proposing that national authorities update their prescribing information. For those who have not been previously infected by dengue virus, vaccination should not be recommended, it added.

The mosquito-spread disease is found in tropical and sub-tropical climates worldwide. In severe cases, dengue can cause breathing problems, haemorrhaging and organ failure.

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"Currently, there is no reported case of severe dengue infection among those who received the vaccine", he told reporters.

Despite the suspension, Duque said "vaccination is essential to the integrated approach in dengue prevention and control". He did not say whether legal action will be taken pending conclusion of a review he has ordered of the contract and other documents on the Dengvaxia immunisation.

But he said the department would strengthen its ongoing surveillance of those who received Dengvaxia and would investigate any cases of people falling ill. That will include mandatory history taking of those vaccinated, mandatory reporting of all hospitalised vaccine recipients regardless of symptoms and 5 years of post-vaccination surveillance.

In a statement, Sanofi said it had recently examined six years of patient data.

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