2023-11-10 15:01:12
November 10, 2023
The American Medicines Agency has just authorized the marketing of the very first vaccine once morest the chikungunya virus, manufactured by the Valneva group.
The Food and drug administration (FDA), the American drug agency, approved the world’s first vaccine once morest chikungunya on Thursday, November 9. “Ixchiq is authorized for people over 18 years of age and who are at increased risk of exposure to the virus,” notes the FDA in a press release. The US Health Agency used an accelerated approval pathway for this vaccine.
“Chikungunya virus infection can lead to severe illness and prolonged health problems, especially in older adults and people with underlying health conditions,” notes Prof. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. And to add: “Today’s approval addresses an unmet medical need and is an important step forward in preventing a potentially very debilitating disease with limited treatment options.”
A live attenuated vaccine
Manufactured by the Valneva laboratory, Ixchiq is a single-injection live attenuated vaccine. Vaccinated people may therefore experience the same symptoms as infected people. Serious adverse reactions were reported in 1.67% of the 3,500 people who participated in the clinical effects. “The FDA requires the company to conduct a post-marketing study to assess the serious risk of serious chikungunya-like adverse reactions following administration of Ixchiq,” it is specified in the press release.
As for the effectiveness of the vaccine, 96.3% of people who participated in phase 3 trials had the necessary antibodies once morest the virus 6 months following vaccination, notes Valneva.
An application for authorization has also been filed with the European Medicines Agency (EMA) and in Canada.
5 million cases over 15 years
Transmitted by the tiger mosquito, chikungunya causes fever and severe joint pain. “Other possible symptoms include joint swelling, muscle pain, headache, nausea, fatigue and skin rashes,” adds the World Health Organization (WHO).
A post-infectious syndrome is also observed and might affect 10% of patients 3 to 5 years following contamination.. “The joint damage can last in a subacute or chronic mode for several months or even several years, and this is all the more common as the age of the patient is advanced,” specifies the Pasteur Institute.
First identified in Tanzania in 1952, the highest risks of infection are in tropical and subtropical Africa, southeast Asia and several American countries. Chikungunya has been identified in 110 countries, notes the WHO, particularly in Europe where the first outbreak took place in 2007 in the north-east of Italy. In France, the first two indigenous cases were detected in 2010 in the Var. In October 2014, 12 other indigenous cases were observed in Montpellier. In 2017, 17 other cases of chikungunya were recorded in the PACA region.
Worldwide, over the last 15 years, according to the FDA, at least 5 million contaminations have been recorded.
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Source : FDA, 9 November 2023 – Valvena, 9 November 2023 – WHO – Institut Pasteur
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Written by : Dorothée Duchemin – Edited by Emmanuel Ducreuzet
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