Dengue Vaccine Receives Priority Review From FDA

Sanofi Pasteur’s dengue vaccine (Dengvaxia) is moving one step closer to being approved in the United States as the US Food and Drug Administration (FDA) just accepted a Biologics License Application for the vaccine. The vaccine was previously granted priority review and included in the FDA’s Tropical Disease Priority Review Voucher Program. It is the “first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need,” according to a statement from Sanofi.

Dengue is a mosquito-borne viral infection that is a leading cause of illness and death in the tropics and subtropics, according to the US Centers for Disease Control and Prevention. Up to 400 million people are infected each year. More than 12,000 cases of dengue infection occurred in Puerto Rico in 2010, prior to the equally devastating Zika virus outbreak that affected the country. Furthermore, dengue was the second most commonly transmitted mosquito-borne disease in the continental United States according to data reported to the National Notifiable Diseases Surveillance System between 2004 and 2016.

This step forward for a vaccine against the virus does not come without concerns. Although the live recombinant tetravalent vaccine has been tested in clinical trials for more than 20 years, and was approved by the World Health Organization (WHO) in 2016 for individuals between the ages of 9 and 45 who are living in dengue-endemic regions, data released last year (2017) revealed that Dengvaxia vaccination may increase the risk of severe disease in individuals who had never been exposed to the virus. Sanofi requested updated labeling for the vaccine; however, the findings prompted the Philippine Health Ministry to halt their vaccination program for the disease. In December 2017, the Public Attorney’s Office of the Philippines announced that 2 children had died from severe dengue following Dengvaxia vaccination. Further examination found a total of 3 deaths potentially related to vaccination.

At that time, Sanofi’s global medical head, Su-Peing Ng, MB, BS, said in a statement that, “In Dengvaxia clinical trials conducted over more than a decade and over one million doses of the vaccine administered, no deaths causally related to the vaccine have been reported to us. These findings highlight the complex nature of dengue infection. We are working with health authorities to ensure that prescribers, vaccinators, and patients are fully informed of the new findings, with the goal of enhancing the impact of Dengvaxia in dengue-endemic countries.”

Speaking on the current application acceptance, David Greenberg, Regional Medical Head North America, Sanofi Pasteur, stated, “Sanofi is committed to reducing the global burden of dengue. The vaccine has been evaluated in studies involving more than 40,000 people from 15 countries around the world with up to six years of follow-up data from large-scale investigations that included Puerto Rico as a study site.”

Dengvaxia, remains the only vaccine available for the prevention of dengue in countries where it is approved. The European Commission is expected to grant marketing authorization for Dengvaxia in December 2018 and the FDA has set a Prescription Drug User Fee Act action date of May 1, 2019.