FDA advisory panel recommends Sanofi’s dengue vaccine in children, but rejects its use in adults

pharmafile | March 11, 2019 | News story | Sales and Marketing FDA, Sanofi, US, Vaccine, dengue, dengvaxia, pharma 

Dengvaxia, Sanofi’s vaccine for dengue fever, has been burdened with further negative scrutiny after the FDA’s vaccine advisory panel passed mixed judgements on its efficacy and safety in adults and children with the disease.

The agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) decided that Sanofi’s vaccine was not effective in preventing the disease in adult patients aged between nine and 45 living in endemic regions who have been previously diagnosed with dengue, with seven votes to six and one abstention.  

However, in patients aged between nine and under 17 in endemic areas with a previous diagnosis, the panel voted 13-1 supporting the vaccine’s efficacy in preventing forms of the disease caused by serotypes 1-4.

When considering the vaccine’s safety, the panel voted seven-for, seven-against on its use in the first group, but in younger patients voted 10-4 in favour of its use.

The panel made these decisions on the back of data derived from 16 studies – two of which were Phase 3 – which demonstrated that Dengvaxia demonstrated an efficacy rate of 60.8% in patients aged between nine and 45, and 56.6% in those aged two to 14.

The vaccine had seen a very troubled launch in the Philippines; after 730,000 children received it, Sanofi confirmed with six-year data that those who had never contracted the virus before were at increased risk of a life-threatening reaction should they contract it after vaccination. Though the manufacturer insisted that there had been no deaths as a result of the treatment, the country’s FDA chose to halt further sales, while Sanofi agreed to reimburse the Department of Health to the tune of nearly $28 million.

A final decision from the US agency is due on 1 May, taking the panel’s decision into account.

Matt Fellows

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