US Food and Drug Administration accepts for review 澳门葡京网赌游戏’s Supplemental Biologics License Application for self-administration of 喷雾疫苗四价的

Potential to be the first and only self-administered flu vaccine

澳门葡京网赌游戏’s Supplemental Biologics License Application (sBLA) for the approval of a self- or caregiver-administered option for 喷雾疫苗四价的, a needle-free nasal spray, has been accepted for review by the US Food and Drug Administration (FDA). 如果得到批准, 流感疫苗 will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an additional option to be vaccinated against influenza. 

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer or administer 流感疫苗 to eligible patients 2-49 years of age when given instructions for use without any additional guidance. 流感疫苗, 喷到鼻子里的是什么, has extensive data demonstrating comparable effectiveness and acceptable safety relative to other flu vaccines.

The Prescription Drug User Fee Act (PDUFA) date, FDA做出监管决定的日期, is expected during the first quarter of 2024. 如果当时获得批准， 流感疫苗 is anticipated to be available for self-administration in the US for the 2024/2025 flu season.

Ravi Jhaveri, MD, Division Head, Infectious Disease; Virginia H. 罗杰斯传染病学教授, Professor of Pediatrics (Infectious Diseases), 西北大学医学院, 芝加哥, 美国说:“一个自我管理的选择 喷雾疫苗四价的 would leverage the unique attributes of the product, providing a convenient new choice for individuals and families who want to protect their loved ones against flu. Vaccination rates for children and adults under 50 years of age declined in the 2022-2023 flu season, highlighting a need for more accessible solutions. The ability for individuals and parents to choose w在这里 to administer an injection-free flu vaccine could help increase access and, 随后, 疫苗接种率, and greatly benefit those most impacted by this serious and contagious respiratory illness.”   

Iskra Reic, 执行副总裁, 疫苗和免疫疗法, 澳门葡京网赌游戏, 他说:“20多年了, 喷雾疫苗四价的 has served as a critical public health tool as the only intranasal flu vaccine providing protection to communities around the world. 流感疫苗 now has the potential to be the first and only self-administered flu vaccine, 哪种疫苗能彻底改变流感疫苗接种. 澳门葡京赌博游戏的目标是 流感疫苗 直接送到人们的家里, 提供创新, 为个人提供更方便的选择, 家庭和社区.”

流感 (flu) is a contagious respiratory illness caused by the influenza virus, which can cause serious complications to some groups, 比如65岁及以上的人, 年幼的孩子, 以及有特定健康状况的人.

笔记

流感
平均, about 8% of the US population gets sick from flu each season, 范围在3%到11%之间, 视季节而定.¹ Children 5 to 17 years of age represent 39% of acute respiratory infection medical visits, even though they only make up about 22% of the US population.² The impact of influenza extends to work and school, as 47% of days of school missed are due to the illness and working caregivers miss 1-2 days of work to care for household members.³

喷雾疫苗四价的 流感减毒活疫苗
喷雾疫苗四价的 is a quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray for the prevention of influenza. 喷雾疫苗四价的 can be used in appropriate children and adults 2 through 49 years of age. 喷雾疫苗四价的 is an Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) 推荐的流感疫苗选择. 喷雾疫苗四价的 was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world.

澳门葡京网赌游戏
澳门葡京网赌游戏 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, 发展, and commercialisation of prescription medicines in 肿瘤学, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门葡京网赌游戏.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.

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