Valneva SE

瓦尔内瓦股份公司

announced that the Brazilian Health Regulatory Agency (ANVISA) approved Ixchiq vacccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older

宣布巴西卫生监管局 (ANVISA) 批准了Ixchiq疫苗，用于预防18岁及以上个体因基孔肯雅病毒引起的疾病。

The ANVISA decision marks the world’s first approval of a ISA) has granted marketing authorization to its single-dose vaccine Ixchiq  for chikungunya in an endemic country. Part of Valneva’s endemic country strategy, this endeavor is supported by the Coalition for Epidemic Preparedness Innovations (CEPI).

巴西国家卫生监督局（ANVISA）的决定标志着全球首次批准单剂量基孔贡雅疫苗Ixchiq在流行国家上市，该疫苗由国际突发疾病预防创新联盟（CEPI）支持，是Valneva公司在流行国家战略的一部分。

, with co-funding from the European Union (EU) and Instituto Butantan

，由欧盟（EU）和布坦坦研究所共同资助

to support broader access to a chikungunya vaccine in low-and-middle-income countries (LMICs).

以支持在中低收入国家（LMICs）更广泛地获取基孔肯雅热疫苗。

This important approval primarily enables initiation of large-scale clinical trials of Ixchiq in Brazil, including the committed Phase IV clinical trials supporting Ixchiq’s approval by the  FDA  and the European Commission to generate additional data on vaccine effectiveness. CEPI is providing funding support to these trials..

这一重要批准主要使得可以在巴西开展 Ixchiq 的大规模临床试验，包括支持 Ixchiq 获得 FDA 和欧洲委员会批准的第四阶段临床试验，以生成更多关于疫苗有效性的数据。CEPI 正在为这些试验提供资金支持。

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, commented, “This approval marks a crucial milestone toward making our chikungunya vaccine available to LMICs where the disease is endemic. The ongoing outbreak in Brazil underscores the fact that containing chikungunya is an international public health priority.

瓦尔内瓦公司首席医疗官胡安·卡洛斯·贾拉米洛博士评论道：“此次批准标志着我们向将基孔肯雅热疫苗提供给该疾病流行的中低收入国家迈出了关键一步。巴西当前的疫情爆发表明，控制基孔肯雅热是国际公共卫生的优先事项。”

Our vaccine is particularly well suited for LMICs, where vaccine access is often limited, due to its ability to induce a robust, long-lasting antibody response in both younger and older adults with a single vaccination. We would like to thank our partners CEPI and Instituto Butantan for helping us address this urgent medical need by accelerating further access to our highly differentiated vaccine.” Dr.

我们的疫苗特别适合中低收入国家，因为在这些国家，疫苗的获取通常受到限制。由于我们的疫苗能够在年轻人和老年人中通过单次接种引发强烈且持久的抗体反应。我们要感谢我们的合作伙伴——流行病防范创新联盟（CEPI）和布坦坦研究所（Instituto Butantan），他们帮助我们加速推进这种高度差异化的疫苗的可及性，以应对这一紧迫的医疗需求。”

Esper Kallás, Director of Instituto Butantan added, “The approval of the chikungunya vaccine is a great victory for Brazil, where over 150,000 people suffer from the disease every year. It is an honor for Butantan to be able to contribute to ensuring that this vaccine reaches the population that needs it the most.”.

埃斯佩尔·卡拉斯，布坦坦研究所主任补充道：“基孔肯雅热疫苗的批准对巴西来说是一次巨大的胜利，那里每年有超过15万人感染这种疾病。能够为确保该疫苗覆盖最需要的人群做出贡献，是布坦坦的荣幸。”

Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI), commented, “As we confront the ongoing challenges posed by chikungunya, today marks a significant step forward in our collective efforts to expand access to an important vaccine to not only benefit the travelers’ market but also populations in need in outbreak-affected countries, like Brazil.

流行病防范创新联盟 (CEPI) 首席执行官 Richard Hatchett 博士评论道：“在我们应对基孔肯雅热带来的持续挑战之际，今天标志着我们在扩大重要疫苗获取渠道方面迈出了重要的一步，这一努力不仅有利于旅行者市场，也有助于像巴西这样的受疫情影响国家的有需求人群。

ANVISA’s marketing authorization of the vaccine offers new hope in the fight against the debilitating disease and allows us to make headway in our goal to protect the tens of thousands in the country who suffer from chikungunya each year. Brazil’s approval is testament to the power of collaboration, innovation and determination and should help set the world up for additional approvals in other endemic regions in the near future.”.

巴西卫生监督局对疫苗的上市授权为抗击这种衰弱性疾病带来了新的希望，并让我们在实现保护每年数以万计遭受基孔肯雅热病痛的巴西人民这一目标上取得进展。巴西的批准证明了合作、创新和决心的力量，将有助于推动世界在未来几个月内，在其他流行地区获得更多的批准。”

Condition:

条件：

Chikungunya  fever

基孔肯雅热

Type:

类型：

drug

药物