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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].
Bavarian Nordic Receives Acceptance from Health Canada for Review of the New Drug Submission for its Chikungunya Vaccine
Globenewswire· 2025-07-22 06:00
Core Viewpoint - Bavarian Nordic A/S has received acceptance from Health Canada for the review of its chikungunya vaccine candidate, CHIKV VLP, which aims to prevent chikungunya virus infection in individuals aged 12 and older, with potential approval expected in the first half of 2026 [1][3]. Group 1: Vaccine Development and Approval - The New Drug Submission for CHIKV VLP is based on data supporting recent approvals in the US, EU, and UK, including results from two phase 3 clinical trials involving over 3,500 participants aged 12 and older [2][4]. - The vaccine demonstrated a neutralizing antibody response in up to 97.8% of vaccinated individuals 21 days post-vaccination, with a seroresponse rate of 96.8% at day 15 for the 12-64 age group and 82.3% for those over 65 [2]. - CHIKV VLP is designed to be non-infectious, containing no viral genetic material, making it suitable for a broad population [4]. Group 2: Market Context and Disease Impact - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, causing significant outbreaks, particularly in popular travel destinations [5]. - In 2024, there were 620,000 reported cases of chikungunya globally, with over 200 deaths, indicating a substantial public health concern [5]. - The disease often presents with severe symptoms, including incapacitating joint pain, and a significant percentage of patients may develop chronic arthritis [5]. Group 3: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in travel vaccines and public health preparedness [6].
Bavarian Nordic Receives Marketing Authorization for Chikungunya Vaccine for Persons Aged 12 and Older in the United Kingdom
Globenewswire· 2025-05-02 06:30
Core Viewpoint - Bavarian Nordic A/S has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its chikungunya vaccine, VIMKUNYA, aimed at individuals aged 12 and older, with a planned launch in the UK during the summer of 2025 [1][2][3]. Group 1: Vaccine Approval and Launch - The approval of VIMKUNYA follows a review under the international recognition procedure, acknowledging prior approvals from other regulatory bodies, including the European Commission [2]. - This marks the third approval for Bavarian Nordic's chikungunya vaccine, following approvals from the U.S. FDA and the European Commission in February 2025 [3]. Group 2: Disease Background - Chikungunya is a mosquito-borne disease that has emerged in over 110 countries, with significant outbreaks reported in Asia, Africa, and the Americas [4]. - In 2024, there were 620,000 reported cases of chikungunya globally, resulting in over 200 deaths, indicating a potential underreporting of the disease [4]. Group 3: Vaccine Details and Efficacy - VIMKUNYA is a single-dose, adjuvanted VLP recombinant protein vaccine designed for active immunization against chikungunya virus [5]. - Phase 3 clinical trials involving over 3,500 participants demonstrated that 21 days post-vaccination, up to 97.8% of individuals developed neutralizing antibodies [6]. Group 4: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in travel vaccines and public health preparedness [7].