The U.S. Food and Drug Administration (FDA) approved Sanofi’s Dengvaxia. It is a vaccine for all four serotypes of dengue. Dengvaxia has previously gained approval from other governments including the European Union and other nineteen companies. It is the first vaccine approved to avoid dengue disease. It is effective in dengue caused by all the dengue virus serotypes (1,2,3, and 4). Dengue is one of the diseases found in the U.S. including regions like Guam, Rico, the U.S. Virgin Islands, and American Samoa. FDA deputy commissioner for policy, legislation, and international affairs, Anna Abram, said dengue is the most common disease spread by mosquito bite. Additionally, the disease has become a global incidence and raised in recent some years.
Anna noted the FDA is functioning actively with its allies at the CDC and global partner WHO. Collectively, the agencies aim to fight against public health risks. The activities range from enabling the development and accessibility of medical products to deal with emerging infectious diseases. Anna said while no treatment exists for dengue, Dengvaxia’s approval has a big importance. It will help the nation to decrease the impact of the virus in epidemic regions of the U.S. The patients receiving the vaccine must have a laboratory report revealing the previous existence of the disease. At the moment, there are no tests have approval from the FDA to find out a past dengue infection. Sanofi notes it is functioning on a test to know earlier clues. Besides, the company intends to submit it to the FDA by the end of 2020.
On the other hand, Dengvaxia has an arguably history. Previously, in 2017, the Philippine government had pulled it out from markets citing safety issues. The vaccine appears liable for 10 deaths in the Philippine. Although Sanofi strongly denies accepting those findings. Around ten countries in Latin America and Asia have approved the vaccine. As of today, the vaccine has gained approval from various parts of the European Union.
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