For immediate release:
May 01, 2019

The US Food and Drug Administration today announced the approval of Dengvaxia, the first approved vaccine for the prevention of dengue fever caused by all dengue virus serotypes (1, 2, 3). and 4) in people aged 9 to 16 who are dengue fever and live in endemic areas. Dengue fever is endemic in the territories of American Samoa, Guam, Puerto Rico and the US Virgin Islands.

"Dengue fever is the most prevalent mosquito-borne viral disease in the world and the global incidence has increased in recent decades," said Anna Abram, FDA's Deputy Commissioner for Policy, Legislation and international affairs. "The FDA is committed to working proactively with its partners in the US Centers for Disease Control and Prevention, as well as with its international partners, including the World Health Organization, to address the threats that lie ahead. public health, including facilitating the development and availability of medical products. treat emerging infectious diseases. Although dengue fever can not be cured, today's approval is an important step in reducing the impact of this virus in endemic areas of the United States. "

The CDC estimates that more than a third of the world's population lives in areas at risk of dengue virus infection, responsible for dengue fever, one of the leading causes of morbidity among people living in tropical and subtropical regions. The first dengue virus infection usually results in the absence of symptoms or a mild illness that can be confused with the flu or other viral infection. Subsequent infection can lead to severe dengue, including dengue haemorrhagic fever (DH), a more serious form of the disease that can be fatal. Symptoms may include stomach pain, persistent vomiting, bleeding, confusion, and difficulty breathing. About 95% of severe / hospitalized dengue cases are associated with a second dengue infection. Since there is no specific drug approved for the treatment of dengue fever, care is limited to symptom management.

Every year, according to the CDC, an estimated 400 million dengue infections occur worldwide. Of these, about 500 000 cases are moving towards DH, contributing to about 20 000 deaths, mainly among children. Although dengue fever is rare in the continental United States, the disease occurs regularly in American Samoa, Puerto Rico, Guam, the US Virgin Islands, as well as in Latin America, Southeast Asia, and South America. the Pacific Islands.

"Infection with one type of dengue virus usually confers immunity against this specific serotype, but subsequent infection with one of the other three serotypes of the virus increases the risk of contracting severe dengue fever." may result in hospitalization or even death, "said Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research. "Since the second dengue infection is often much more serious than the first, the approval of this vaccine by the FDA will help protect people previously infected with the dengue virus from further development of the disease."

The safety and efficacy of the vaccine was determined in three randomized, placebo-controlled studies involving approximately 35,000 people living in endemic areas, including Puerto Rico, Latin America and Asia. -Peaceful. It has been determined that the vaccine is approximately 76% effective in the prevention of laboratory-confirmed symptomatic dengue fever in persons aged 9 to 16 years who have already experienced laboratory-confirmed dengue fever. Dengvaxis has already been approved in 19 countries and the European Union.

The most common side effects reported by patients treated with Dengvaxia were: headache, muscle pain, joint pain, fatigue, injection site pain and low-grade fever. The frequency of adverse events was similar in Dengvaxia and placebo patients and tended to decrease after each subsequent dose of the vaccine.

The use of Dengvaxia is not approved in people who are not yet infected with a dengue virus serotype or for whom this information is unknown. Indeed, in people who have not been infected with the dengue virus, dengvaxia seems to behave like a first infection of dengue fever – without infecting the person with the wild-type dengue virus. – so that subsequent infection can lead to severe dengue disease. Health care professionals should evaluate people for pre-dengue infection to avoid vaccinating people who have never been infected with the dengue virus. This can be assessed through a medical record of an earlier dengue infection confirmed in the laboratory or by serologic tests (tests using patient blood samples) prior to vaccination.

Dengvaxia is a live attenuated vaccine administered in three separate injections. The initial dose is followed by two additional injections given six and twelve months later.

The FDA has granted this application priority study and a priority review voucher for tropical diseases as part of a program to encourage the development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The approval was granted to Sanofi Pasteur.

The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.

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