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Johnson Fistel Investigates Valneva Following FDA Suspension
GlobeNewswire News Room· 2025-08-25 14:43
Core Viewpoint - Johnson Fistel, PLLP is investigating potential claims on behalf of investors of Valneva SE regarding possible violations of federal securities laws due to alleged misrepresentations and omissions by the company and its executives [1] Company Developments - On August 25, 2025, Valneva acknowledged that the FDA suspended the license for its chikungunya vaccine Ixchiq, following four reports of serious adverse events, mandating the cessation of all shipping and sale of the vaccine within the United States [3] Legal Context - Investors who purchased Valneva securities and incurred significant losses may be eligible to participate in a potential class action or seek recovery of their losses [2]
基孔肯雅热不属于法定传染病,两款疫苗获批
仪器信息网· 2025-07-29 03:22
Core Viewpoint - The article discusses the rising threat of Chikungunya virus, particularly in Guangdong, China, and highlights the approval of two vaccines, VIMKUNYA and Ixchiq, which are effective in preventing the disease for individuals aged 12 and above [1][4][6]. Group 1: Disease Overview - Chikungunya is a mosquito-borne viral disease characterized by acute symptoms such as fever, rash, fatigue, and severe joint pain, with a low mortality rate but high incidence [4]. - Approximately 50% of Chikungunya patients experience debilitating long-term symptoms, which may worsen with age [4]. - The disease primarily spreads in tropical and subtropical regions, with local transmission in China being rare [3]. Group 2: Current Situation - In Guangdong, the number of confirmed Chikungunya cases has exceeded 3,000, with occasional imported cases reported in Beijing [4]. - The World Health Organization has warned that around 5.5 million people across 119 countries and regions are at risk of Chikungunya [4]. Group 3: Vaccine Approvals - VIMKUNYA, developed by Bavarian Nordic, is the first Chikungunya vaccine approved by the FDA for individuals aged 12 and older [6][8]. - Ixchiq, developed by Valneva, is another vaccine aimed at protecting individuals aged 12 to 64 from Chikungunya virus infection [10][12]. Group 4: Vaccine Efficacy and Safety - VIMKUNYA demonstrated a 97.8% neutralizing antibody response within 21 days post-vaccination in clinical trials involving over 3,500 participants [8]. - Common side effects of VIMKUNYA include injection site pain, fatigue, headache, and muscle pain [9]. - Ixchiq may cause side effects such as leukopenia, neutropenia, lymphopenia, headache, fatigue, and elevated liver enzymes, particularly in individuals over 65 or those with immune deficiencies [14].