新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 诺华 » 诺华乙脑疫苗Bexsero获澳大利亚批准

诺华乙脑疫苗Bexsero获澳大利亚批准

来源:生物谷 2013-08-16 01:32

2013年8月15日讯 /生物谷BIOON/ --诺华(Novartis)今天宣布,乙脑(meningitis B,MenB)疫苗Bexsero获澳大利亚治疗物品管理局(TGA)批准,用于年龄在2个月以上的人群。

Bexsero是首个也是唯一一个宽覆盖范围的乙脑疫苗,用于帮助保护所有年龄段人群预防乙脑,包括婴儿。

今年1月,Bexsero获得了欧盟委员会(EC)的批准,该批准适用于所有28个欧盟成员国及冰岛、列支敦士登、挪威。目前,Bexsero已获30多个国家批准,进一步的监管申请提交正在进行中。

脑膜炎非常容易被误诊,有时尽管采取了适当的治疗,发病后24小时内的死亡率仍高达10%。另一方面,约有20%的幸存者会留下终身残疾,例如脑损伤、听力障碍或肢体残缺等。因此,通过疫苗接种的预防措施是减少该疾病负担的最优方法。在发达国家,乙型脑膜炎在婴儿中尤为高发。

脑膜炎球菌是细菌性脑膜炎的主要原因。5株主要的脑膜炎双球菌(A,B,C,W-135,Y)引发了全球大多数病例。Bexsero仅针对其中4株(A、C、W-135、Y)产生保护作用。(生物谷Bioon.com)

英文原文:Novartis vaccine Bexsero approved in Australia

Australia approval marks a key step in expanding access to the first and only broad coverage vaccine against MenB disease[1],[2];Bexsero was granted European licensure this past January[1]

MenB disease is a leading cause of meningitis and sepsis globally, and causes approximately 85 percent of all meningococcal disease cases in Australia[3],[4],[5]

Bexsero safety and efficacy have been shown through clinical trials involving more than 8,000 people including infants, children, adolescents and adults

Basel, August 15, 2013 - Novartis announced today that the Australian Therapeutic Goods Administration (TGA) has added Bexsero?, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older[6]. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest risk of infection[7],[8].

Across Australia, approximately 85 percent of all meningococcal disease and sepsis cases have been caused by MenB, a percentage that has risen in recent years as the number of cases in other serogroups has fallen[3],[5]. The introduction of vaccines for other strains of bacterial meningitis has been successful in reducing the disease burden in Australia; specifically, following the rollout of a national meningococcal serogroup C vaccination program in Australia, cases decreased from 162 in 2002 to nine by 2011[3],[5].

"Novartis welcomes the Australian health authorities' decision to license Bexsero, which is further testament to the vaccine's demonstrated robust efficacy and safety profiles and an important step in preventing further suffering caused by MenB disease," said Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics. "We are committed to bringing Bexsero to parents around the globe that want to protect their children against this devastating disease."

MenB is a potentially deadly disease which is easily misdiagnosed and can kill within 24 hours of onset. About one in 10 of those who contract the disease will die despite appropriate treatment. Up to one in five survivors may suffer from devastating, life-long disabilities such as brain damage, hearing impairment or limb loss[4]. The consequences for those affected and the healthcare system are significant[9].

"Today marks another victory, particularly for Australian children, parents and pediatricians, in the fight against meningococcal disease," said Bruce Langoulant, President and Asia Pacific Regional Leader, Confederation of Meningitis Organisations. "We are now entering a critical period for public health authorities to provide funding to include the new MenB vaccine in the routine immunization schedules to ensure community-wide protection against the tragic deaths and lasting disabilities MenB can cause."

As a next step, Novartis will work with Australian regulatory authorities to make doses of Bexsero available in the private market in the coming months. In parallel, the Pharmaceutical Benefits Advisory Committee (PBAC), taking into account advice from the Australian Technical Advisory Group on Immunisation (ATAGI), is expected to make recommendations regarding reimbursement and potential inclusion of Bexsero in the National Immunisation Program (NIP)[10],[11].

In January 2013, Bexsero received marketing authorization from the European Commission which applies to all 28 European Union (EU) member states, Iceland, Liechtenstein and Norway[1],[2]. With this TGA decision, Bexsero is now licensed in more than 30 countries and further regulatory filings are underway.

Meningococcal disease is a leading cause of bacterial meningitis. Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of all cases around the world[12]. Prior to Bexsero, vaccines were available to help protect only against A, C, W-135 and Y[4].

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库