In a landmark move, FDA announces their first approval of a dengue vaccine, Dengvaxia, which is produced by French pharmaceutical Sanofi Pasteur.
Dengvaxia is the first dengue vaccine approved to prevent all the virus serotypes of the mosquito-borne virus.
While FDA has given the go signal for the use of Dengvaxia, the agency stressed in a news release that the vaccine should only be used on individuals aged 9 to 16 years who have previously had dengue infections and live in endemic areas.
The virus is endemic in the following United States territories: American Samoa, Guam, Puerto Rico, and the U.S. Virgin Islands.
Dengvaxia Provides Protection Against Severe Dengue
The first infection of the dengue virus is typically harmless with no symptoms or mild flu-like symptoms. Subsequent infections could be much more serious, possibly leading to severe dengue, such as the potentially fatal dengue hemorrhagic fever.
Ninety-five percent of all severe or hospitalized cases of dengue are already a second infection.
According to Peter Marks, M.D., the director of FDA's Center for Biologics Evaluation and Research, getting infected by one serotype of the dengue virus will give an individual immunity against that specific serotype. However, if an individual gets a subsequent infection by any of the remaining three virus serotypes, he or she is at increased risk of developing severe dengue disease.
"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," Marks continued.
Dengvaxia Effectivity, Controversy
Sanofi's vaccine has already been approved for use in 19 countries and the European Union.
Previous studies have determined the safety and effectiveness of the vaccine, with researchers finding Dengvaxia is approximately 76 percent effective in preventing dengue disease in people 9 to 16 years old who have already previously contracted a first dengue disease.
However, the vaccine is not without controversy. In the Philippines, which is the first country to approve the vaccine back in 2016, Dengvaxia has also been banned over safety concerns.
FDA says that Dengvaxia acts like a first infection in people who have not been previously infected by any senotype of the virus. Thus, if people who have never been infected by any type of dengue are given the vaccine, a subsequent infection can lead to severe dengue disease.
CDC reveals that over one-third of the global population lives in areas vulnerable to the dengue virus with 400 million cases annually. The virus causes dengue fever, which is a leading cause of illness in populations living in the tropics and subtropics.
"Dengue disease is the most common mosquito-borne viral disease in the world and global incidence has increased in recent decades," said Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs. "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."