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FDA Approves Dengvaxia, The Dengue Vaccine


A disease that affected 9 countries in the world a few decades ago, dengue has now become endemic, affecting nearly half of the global population.

Dengue is a mosquito-borne viral infection, found in tropical and sub-tropical climates. As the disease has no specific treatment, only early detection and proper medical care can lower the fatality rates.

The FDA green signalled Dengvaxia, the first vaccine for the prevention of dengue on May 1.

Developed by Sanofi Pasteur, Dengvaxia is indicated for the prevention of dengue caused by all dengue virus serotypes 1, 2, 3 and 4 in people 9 through 16 years of age living in endemic areas who have laboratory-confirmed previous dengue infection.

Dengvaxia is a live, attenuated vaccine that is administered as three separate injections, with the initial dose followed by two additional shots given six and twelve months later.

The vaccine was approved by European Medicines Agency in December 2018, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore in 2016 and Mexico, Philippines, and Brazil in December 2015.

However, Philippines suspended the distribution of Dengvaxia in 2017 after Sanofi's post-marketing studies revealed that the vaccine posed a risk of severe infection and hospitalizations in children who have never had a dengue infection although it offered protection to those who had a prior history of dengue infection. In February 2019, the country permanently banned the vaccine, following the continued failure of Sanofi to submit post-approval commitment documents.

Now, let's take a look at the new drugs that won FDA approval in April.

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