Sanofi’s Dengvaxia becomes first FDA-approved dengue vaccine, but with caveats…
pharmafile | May 2, 2019 | News story | Sales and Marketing | FDA, Sanofi, dengue, dengvaxia, pharma
Sanofi has announced that the FDA has granted authorisation to its tetravalent vaccine Dengvaxia for prevention of dengue disease originating from all four virus serotypes, making it the first therapy to secure approval from the US regulator in that indication.
The ruling specifically indicates use of the vaccine in patients between the ages of nine and 16, and only those who have laboratory-confirmed previous dengue infection and who live in endemic areas. These include the United States territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.
While historic, the approval is very limited, and follows the ruling by an advisory FDA panel in March to exclude adult patients from its potential treatable population. Dengvaxia has been plagued with controversy after Sanofi conceded that the vaccine could pose a risk to individuals who had not previously been exposed to the virus, and only after it had been administered to 800,000 children in the Philippines after a rollout in the country.
“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,” said Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Over one-third of the global population live in endemic areas and are at-risk of the dengue virus, according to the Centers for Disease Control and Prevention (CDC). While the first contraction of the virus rarely results in symptoms or anything more than mild flu-like illness, second infection can lead to severe cases of dengue fever, accounting for around 95% of all hospitalisations relating to the virus.
“Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades,” commented Anna Abram, FDA Deputy Commissioner for Policy, Legislation, and International Affairs. “The FDA is committed to working proactively with our partners at the US Centers for Disease Control and Prevention, as well as international partners, including the World Health Organization, to combat public health threats, including through facilitating the development and availability of medical products to address emerging infectious diseases. While there is no cure for dengue disease, today’s approval is an important step toward helping to reduce the impact of this virus in endemic regions of the United States.”
Matt Fellows
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