新型流脑疫苗获FDA批准上市
2012年6月14日，美国食品与药物管理局（FDA）批准了一种用于抗婴幼儿脑膜炎的联合疫苗。FDA表示，该疫苗是首个可用于年龄小至6周婴儿的流行性脑脊髓膜炎（简称流脑）疫苗，它可抗两种类型的细菌，包括脑膜炎奈瑟菌（C群和Y群）和B型流行性感冒嗜血杆菌（简称Hib），每种细菌均可感染患者的脑膜和脊髓膜。
脑膜炎奈瑟菌和Hib引起的疾病可导致死亡或严重而持久的损伤，如智能障碍和失明。因该病进展迅速，临床表现难以与那些常见的儿童期表现相鉴别，所以对于年龄<2岁的婴幼儿尤其危险。
该疫苗名为Menhibrix，其有效性是基于纳入上百名注射该疫苗的婴幼儿的多项试验确定的。这些婴幼儿对Hib成分的免疫应答类似于那些接受侵袭性Hib疾病疫苗的婴幼儿。它也促使人体产生抗脑膜炎球菌成分的抗体，预示其可防御由脑膜炎奈瑟菌C群和Y群引起的脑膜炎球菌性疾病。
Menhibrix的安全性是通过一项纳入7500名婴幼儿的粗略研究确定的。常见的不良反应包括注射部位疼痛、发红和隆起，过敏和发热。
Menhibrix分为4种剂量，分别适用于2、4、6月和12~16个月龄的婴幼儿注射，最低剂量可用于6周龄婴儿，最高剂量可用于18月龄幼儿接种。
MENHIBRIX Rx
Generic Name and Formulations:
Neisseria meningitidis polysaccharides 5mcg each of Groups C and Y (tetanus toxoid conjugate [5mcg and 6.5mcg]) + Haemophilus b polysaccharides 2.5mcg (tetanus toxoid conjugate 6.25mcg); per 0.5mL; lyophilized pwd for IM inj after reconstitution; contains trometamol, sucrose, residual formaldehyde; latex-, preservative-free.
Company:
GlaxoSmithKline
Indications for MENHIBRIX:
Immunization against N. meningitidis serogroups C and Y, and H. influenzae type b in children 6 weeks through 18 months of age.
Adult:
Not applicable.
Children:
<6 weeks or 19 months–16 years: not established. Give by IM inj in anterolateral thigh (if <1year old) or in deltoid muscle. 0.5mL given as a 4-dose series at 2, 4, 6, and 12–15 months of age. May give 1st dose as early as 6 weeks and 4th dose as late as 18 months of age.
Contraindications:
Severe allergic reaction to any previous dose of meningococcal-, H. influenza type b-, or tetanus toxoid-containing vaccine.
Warnings/Precautions:
Not a substitute for routine tetanus immunization. Guillain-Barre syndrome within 6 weeks of a previous tetanus toxoid-containing vaccine. Immunosuppressed. Have epinephrine inj (1:1000) available. Pregnancy (Cat. C).
Interactions:
Concomitant vaccines: see full labeling. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose corticosteroids) may get suboptimal response.
Adverse Reactions:
Local inj site reactions (eg, pain, redness, swelling), irritability, drowsiness, loss of appetite, fever; syncope, apnea in premature infants.
How Supplied:
Single-dose vials—10 (w. diluent)
