Bexsero( Meningococcal group B vaccine) 中文药名：重组脑膜炎球菌组-B疫苗
2015年1月23日，美国食品药品监督管理局(FDA)批准Bexsero，一个疫苗预防10至25岁个体中由脑膜炎奈瑟氏菌血清组B引起的侵袭性脑膜炎球菌病。
Bexsero是在过去三个月内被FDA批准预防此病的第二个疫苗。监管局在2014年10月批准了第一个脑膜炎双球菌血清组B 疫苗。在这些批准前，存在在美国被批准脑膜炎双球菌疫苗仅覆盖脑膜炎奈瑟氏菌细菌致脑膜炎球菌病五种主要血清组的四个：A，C，Y和W。
脑膜炎球菌病是细菌所致危及生命疾病可能感染血流(败血症)或如脑和脊髓周围衬里(脑膜炎)。脑膜炎奈瑟氏菌是是细菌性脑膜炎的主要原因。细菌是从人被传播至人通过呼吸或喉分泌物(如，通过咳嗽，接吻或共用餐具)。按照美国疾病控制和预防中心，在2012年在美国被报道约500脑膜炎球菌病总病例，其中160例是血清组B所致。
FDA的生物制品评价和研究中心主任Karen Midthun，医学博士说：“随今天Bexsero的批准，美国现有两个为预防脑膜炎球菌病血清组B疫苗，”“这些结局的批准并不总是预防。疫苗接种是预防脑膜炎球菌病最有效方法。”
在加拿大，澳大利亚，智利，和联合王国中约2,600青少年和青壮年中进行三项研究评价Bexsero的有效性。研究参加者接受兩剂Bexsero，疫苗接种后，在一个实验室进行测试62至88%在他们血中有抗体杀死三种不同脑膜炎奈瑟氏菌血清组B株，与之比较，疫苗接种前有0至23 %。这些三株代表在美国所致血清组B脑膜炎球菌病。
在美国和国外进行研究在约5,000例接受疫苗Bexsero参加者评估安全性。接受Bexsero最常报道的副作用是在注射部位疼痛和肿胀，头痛，腹泻，肌肉痛，关节痛，疲乏，和发冷。此外，在美国批准在多于15,000个体接受Bexsero前对两个大学血清组B 脑膜炎球菌病爆发反应监视安全性。。
FDA采用加速批准监管途径批准Bexsero。加速批准允许监管局批准对严重或危及生命疾病根据产品的有效性证据是合理地可能预测临床获益，减少医疗急需产品被公众得到的时间。在FDA对加速批准，有效性的证据被Bexsero接受体抗体杀死三种代表性脑膜炎奈瑟氏菌血清组B测试株能力证实。作为加速批准过程的部分，制造商经进行进一步研究证明Bexsero对脑膜炎奈瑟氏菌血清组B另外株的有效性。
Bexsero被授权突破性治疗状态，它意向加快解决严重或危及生命情况医疗产品的发展和评审。疫苗的发展期间FDA与公司紧密工作，和能评价 Bexsero的安全性和有效性和比优先审评目标日期提前2个月批准它。在Bexsero被授权突破性治疗状态时，没有预防血清组B 脑膜炎球菌病其他FDA-批准的疫苗可得到。
Bexsero是由总部在马萨诸塞州剑桥的诺华疫苗和诊断公司制造。

Bexsero( Meningococcal group B vaccine)
Active Substance: recombinant Neisseria meningitidis group-B NHBA fusion protein / recombinant Neisseria meningitidis group-B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / outer membrane vesicles from Neisseria meningitidis group-B strain NZ98 / 254 measured as amount of total protein containing the PorA P1.4
Common Name: meningococcal group-B vaccine (rDNA, component, adsorbed)
ATC Code: J07AH09
Marketing Authorisation Holder: Novartis Vaccines and Diagnostics S.r.l.
Active Substance: recombinant Neisseria meningitidis group-B NHBA fusion protein / recombinant Neisseria meningitidis group-B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / outer membrane vesicles from Neisseria meningitidis group-B strain NZ98 / 254 measured as amount of total protein containing the PorA P1.4
Status: Authorised
Authorisation Date: 2013-01-14
Therapeutic Area: Meningitis, Meningococcal
Pharmacotherapeutic Group: Meningococcal vaccines

BEXSERO is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
The impact of invasive disease in different age groups as well as the variability of antigen epidemiology for group B strains in different geographical areas should be considered when vaccinating.
The use of this vaccine should be in accordance with official recommendations.
BEXSERO® Important Safety Information
•Hypersensitivity to any components of BEXSERO is a contraindication to administration. Administration of BEXSERO should be postponed in subjects suffering from an acute severe febrile illness. Minor infection, such as cold, should not result in the deferral of vaccination. BEXSERO should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of BEXSERO.
•There are no data on the use of BEXSERO in individuals above 50 years of age, in patients with chronic medical conditions or in individuals with impaired immune responsiveness. In immunocompromised individuals, vaccination may not result in a protective antibody response. Insufficient clinical data on exposed pregnancies are available and there are no data on fertility in humans.
•BEXSERO is not expected to provide protection against all circulating meningococcal group B strains.
•The most common adverse reactions observed in clinical trials of infants were tenderness and erythema at the injection site, irritability, fever, and irritability. Fever occurred more frequently when BEXSERO was co-administered with other routine infant vaccines than when it was given alone.
•Higher rates of antipyretic use were also reported for infants vaccinated with BEXSERO and routine vaccines. When BEXSERO was given alone, the frequency of fever was similar to that associated with routine infant vaccines administered during clinical trials. When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
•Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when BEXSERO was co-administered with routine vaccines, separate vaccinations can be considered when possible.
•In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.