Sanofi’s dengue vaccine secures FDA approval

Sanofi has received approval from the US Food and Drug Administration (FDA) for Dengvaxia, a vaccine that is designed to prevent all four dengue disease serotypes.

The FDA’s approval is limited to people between nine and 16 years of age in endemic areas of the US such as American Samoa, Guam, Puerto Rico and the US Virgin Islands.

In addition, the vaccine can only be given to individuals with a history of the disease, as it can exacerbate the symptoms of individuals that have not previously been infected.

"A subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease."

The FDA Center for Biologics Evaluation and Research director Peter Marks said: "Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalisation or even death.

"As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease."

Dengvaxia is a live, attenuated vaccine formulated for administration as three separate injections. The second and third doses are provided after six and 12 months respectively.

The FDA reviewed safety and effectiveness data from three randomised, placebo-controlled trials conducted in nearly 35,000 people living in dengue-endemic areas, including Puerto Rico, Latin America and the Asia-Pacific (APAC).

Data showed that the vaccine was around 76% effective in preventing symptomatic, laboratory confirmed dengue disease.

Dengvaxia already holds approvals in multiple countries, including Latin America, Asia and the EU.

Dengvaxia had been a subject of controversy in the Philippines after 14 children administered with the vaccine reportedly died.

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.