FDA Approves Dengue Virus Vaccine for Pediatric Patients

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FDA "src =" https://s3.amazonaws.com/hcplive/v1_media/_image/FDA-BW.jpg "style =" float: right; height: 250px; margin: 5px; width: 250px "The US Food and Drug Administration (FDA) has approved the first vaccine for the prevention of dengue disease caused by all serotypes, in people aged 9-16 years old. <p>Dengvaxia, from Sanofi Pasteur, will be able to help at-risk pediatric patients facing the endemic in US territories including Samoa, Guam, Puerto Rico, and the US Virgin Islands.</p> <p>The virus can present itself in serotypes 1, 2, 3, and 4, and is prevalent in one of the world's third regions of the world, according to the US Centers for Disease Control Prevention (CDC). Dengue fever is the leading cause of illness among people living in the tropical and subtropical region, and is generally badociated with misleading, mild-onset patients.</p> <p>Subsequent infections may include stomach pain, persistent vomiting, bleeding, confusion and difficulty breathing. Approximately 95% of all severe cases of dengue fever are badociated with second-hand infection.</p> <p>An estimated 400 million annual dengue virus infections occur globally, according to the CDC. Of those, about 500,000 cases develop into dengue hemorrhagic fever (DHF). The condition contributes to about 20,000 annual deaths, primarily in pediatric patients.</p> <p>"While there is no cure for dengue disease, this is an important step towards helping to reduce the impact of this virus in endemic regions of the United States," Anna Abram, FDA deputy commissioner for policy, legislation, and international affairs, said in a statement.</p> <p>The randomized, placebo-controlled trials involved approximately 35,000 participants in dengue-endemic areas including Puerto Rico, Latin America, and the Asia Pacific region. Investigators reported the vaccine had an approximate 76% efficacy in preventing symptomatic, laboratory-confirmed dengue disease among patients aged 9-16 years old who had previously laboratory-confirmed dengue disease.</p> <p>Commonly reported adverse events including headache, plain muscle, joint pain, fatigue, injection site bread, and low-grade fever. Dengvaxia virus is not approved for any virus serotype.</p> <p>Peter Marks, MD, director of the FDA 's Center for Biologics Evaluation and Research, explained that the type of dengue virus typically provides immunity against that speficic serotype.</p> <p>"" But a serotype of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death, "Marks said. "As the second infection is more severe than the first, the FDA's approval of this vaccine will help protect people with dengue fever."</p> <p>Dengvaxia is approved under the Priority Review and Tropical Disease Priority Review Voucher programs-the latter of which encourages the development of new drugs and biologics for the prevention and treatment of tropical diseases.</p> </div> </pre> [ad_2] <br /><a href=Source link

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