——FDA批准GSK肌注四价疫苗FluLaval Quadrivalent
8月16日，葛兰素史克（GSK）旗下四价流感疫苗FluLaval Quadrivalent获得美国食品药品管理局（FDA）批准，FDA成为批准该款疫苗的首个药品监管机构。
FDA批准FluLaval Quadrivalent用于3岁或更大年龄患者，该疫苗可预防A亚型和B亚型流感病毒。FluLaval Quadrivalent旨在保护针对2种A株和2种B株流感病毒株的感染，降低儿童、成人、老年人的发病率。这款疫苗是FDA批准的第二款肌肉注射型四价疫苗(2012年12月，FDA批准了GSK的另一款肌注四价疫苗Fluarix Quadrivalent,是有史以来首个肌注流感疫苗)。
根据GSK提供的信息，该公司生产有30多款疫苗，并一直在寻求开发用于A型流感病毒两种亚型和B型流感病毒两种亚型的疫苗，以更好地应对潜在的致命病毒，而前代的三价疫苗仅覆盖B型流感病毒一种亚型和A型病毒两种亚型。
随着FluLaval Quadrivalent的获批，GSK称，预计在2014-2015流感季节向美国供应3500万剂四价流感疫苗。GSK称，从2014年开始，将有能力向美国大量供应四价流感疫苗FluLaval Quadrivalent和Fluarix Quadrivalent。
就在8月12日，FDA批准了GSK的HIV新药Tivicay，这款药物预计会成为一款重磅炸弹级产品。Tivicay通常也被称为Dolutegravir，其年销售额预计会超过10亿美元。Dolutegravir是一种新的整合酶抑制剂，而流感疫苗与其不同，流感疫苗已经应用了大约50年。所以葛兰素史克与其它疫苗生产企业不断地寻求新的方法，以改善他们的流感疫苗，提供更大的病毒株覆盖范围，简化配送方式并提供其它优势。
FLULAVAL® (Influenza Virus Vaccine) 5mL Multi-Dose Vials - 10 Doses/Vial
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INDICATIONS AND USAGE
FLULAVAL is an inactivated influenza virus vaccine indicated for active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. (1)
This indication is based on immune response elicited by FLULAVAL, and there have been no controlled trials demonstrating a decrease in influenza disease after vaccination with FLULAVAL. (1, 14)
DOSAGE AND ADMINISTRATION
A single 0.5-mL intramuscular injection. (2.2)
DOSAGE FORMS AND STRENGTHS
FLULAVAL is a suspension in 5-mL multi-dose vials containing 10 doses (each dose is 0.5 mL). (3)
CONTRAINDICATIONS
Known systemic hypersensitivity reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous influenza vaccination. (4)
WARNINGS AND PRECAUTIONS
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLULAVAL should be based on careful consideration of the potential benefits and risks. (5.1)
Immunosuppressed persons may have a reduced immune response to FLULAVAL. (5.2)
ADVERSE REACTIONS
Most common (≥10%) local adverse events were pain, redness, and/or swelling at the injection site. (6.1)
Most common (≥10%) systemic adverse events were headache, fatigue, myalgia, low grade fever, and malaise. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
DRUG INTERACTIONS
Do not mix with any other vaccine in the same syringe or vial. (7.1)
Immunosuppressive therapies may reduce immune responses to FLULAVAL. (7.2)
USE IN SPECIFIC POPULATIONS
Safety and effectiveness of FLULAVAL have not been established in pregnant women, nursing mothers, and children. (8.1, 8.3, 8.4)
Geriatric Use: Antibody responses were lower in geriatric subjects than in younger subjects. (8.5)
Revised: May 2010