总部位于澳大利亚的疫苗制造商CSL Ltd及其子公司CSLBiotherapies宣布，已与制药商默沙东公司(MRK)达成了一项为期6年的流感疫苗营销及代销协议。
此项交易的财务条款未予透露。
根据协议，从2010-2011流感季节开始，默沙东将拥有在美国独家销售及代销CSL的季节性流感疫苗Afluria的权利。CSL将保留这款疫苗的生产许可。
这款疫苗已于2007年9月份获得了美国监管机构的批准。

CSL Biotherapies' H1N1 and seasonal influenza vaccines approved for children
The FDA has approved the use of CSL Biotherapies' 2009 H1N1 monovalent influenza vaccine for use in infants and children ≥6 months of age.
Theexpanded approval also covers CSL's seasonal influenza vaccine Afluria (trivalent, inactivated, "split virus" influenza vaccine [Types A and B]).
The approval was based on study data in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza.
These efficacy findings supported approval under FDA's accelerated approval regulation.

CSL's 2009 H1N1 influenza vaccine and Afluria are already approved for use in adults ≥18 years of age.

Generic Name for AFLURIA

Trivalent, inactivated, "split virus" influenza vaccine (Types A and B); formulation changes annually; susp for IM inj; may contain trace amounts of neomycin sulfate, polymyxin B.

Legal Classification:

Rx

Manufacturer of AFLURIA

CSLBiotherapies

Indications for AFLURIA

Influenza immunization.

Adult dose for AFLURIA

≥18yrs: 0.5mL by IM inj once in deltoid.

Children's dosing for AFLURIA

<18yrs: not recommended.

Contraindications for AFLURIA

Allergy to egg or chicken proteins, neomycin, polymyxin. Life-threatening reaction to any previous flu vaccine.

Precautions for AFLURIA

Use current formulation only. Have epinephrine inj (1:1000) available. Guillain-Barre syndrome within 6weeks of previous flu vaccine. Immunosuppressed. Pregnancy (Cat.C). Nursing mothers.

Interactions for AFLURIA

Concomitant vaccines: insufficient data (see literature). Immunosuppressants (eg, corticosteroids): may get suboptimal response.

Adverse Reactions for AFLURIA

Local reactions (eg, tenderness, redness, swelling, pain), headache, malaise, muscle aches.

How is AFLURIA supplied?

Single-dose prefilled syringe 0.5mL (preservative-free)—10 (without needles)Multi-dose vial 5mL (contains thimerosal)-1

RelatedDisease:

Immunization Influenza~vaccines

Related Resources

FDA近日已批准2008-2009季节性流感疫苗
近日，FDA批准了2008-2009期间的季节性流感疫苗，获准的产品共有六种，其中包括在2008-2009这一时期可能会在美国诱发流感的新型菌种。
      　　
这6种疫苗分别是：CSL公司的Afluria；GSK公司的Fluarix；魁北克ID生化公司的FluLaval；MedImmune疫苗公司的FluMist；诺华公司的Fluvirin和赛诺菲-巴斯德公司的Fluzone。
      　　
FDA在审批流感疫苗时，通常会根据最有可能诱发流感的菌种而定，批准的疫苗与当时流行的病毒越接近，疫苗所发挥的保护作用就更大。
      　　
有时事先预测的流感病毒有可能与真正流行的病毒不一致，这使获准的疫苗不能与致病病毒完全匹配，但这样的疫苗仍然可以起到一定程度的保护作用、缓解病情或防止流感并发症等。
      　　
接种流感疫苗仍然是预防流感的基础。据统计，美国每年有5-20%的人会患上流感，其中有超过20万的患者因并发症需住院治疗，而3.6万人会因为流感死亡。其中，老年人、儿童和慢性病患者是流感并发症的高危人群。