"The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the p"...
(Influenza Vaccine Live, Intranasal) Intranasal Spray
FluMist Quadrivalent (Influenza Vaccine Live, Intranasal) is a live quadrivalent vaccine for administration by intranasal spray. FluMist Quadrivalent contains four vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and two B strains. FluMist Quadrivalent contains B strains from both the B/Yamagata/16/88 and the B/Victoria/2/87 lineages. FluMist Quadrivalent is manufactured according to the same process as FluMist.
The influenza virus strains in FluMist Quadrivalent are (a) cold-adapted (ca) (i.e., they replicate efficiently at 25°C, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., they are restricted in replication at 37°C (Type B strains) or 39°C (Type A strains), temperatures at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (i.e., they do not produce classic influenza-like illness in the ferret model of human influenza infection).
No evidence of reversion has been observed in the recovered vaccine strains that have been tested (135 of possible 250 recovered isolates) using FluMist [see CLINICAL PHARMACOLOGY]. For each of the four reassortant strains in FluMist Quadrivalent, the six internal gene segments responsible for ca, ts, and att phenotypes are derived from a master donor virus (MDV), and the two segments that encode the two surface glycoproteins, hemagglutinin (HA) and neuraminidase (NA), are derived from the corresponding antigenically relevant wild-type influenza viruses. Thus, the four viruses contained in FluMist Quadrivalent maintain the replication characteristics and phenotypic properties of the MDV and express the HA and NA of wild-type viruses. For the Type A MDV, at least five genetic loci in three different internal gene segments contribute to the ts and att phenotypes. For the Type B MDV, at least three genetic loci in two different internal gene segments contribute to both the ts and att properties; five genetic loci in three gene segments control the ca property.
Each of the reassortant strains in FluMist Quadrivalent express the HA and NA of wild- type viruses that are related to strains expected to circulate during the 2015-2016 influenza season. Three of the viruses (A/H1N1, A/H3N2 and one B strain) have been recommended by the United States Public Health Service (USPHS) for inclusion in the annual trivalent and quadrivalent influenza vaccine formulations. An additional B strain has been recommended by the USPHS for inclusion in the quadrivalent influenza vaccine formulation.
Specific pathogen-free (SPF) eggs are inoculated with each of the reassortant strains and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled, and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce the monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks from the four strains are subsequently blended and diluted as required to attain the desired potency with stabilizing buffers to produce the quadrivalent bulk vaccine. The bulk vaccine is then filled directly into individual sprayers for nasal administration.
Each pre-filled refrigerated FluMist Quadrivalent sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the four strains: A/Bolivia/559/2013 (H1N1) (an A/California/7/2009 (H1N1)pdm09-like virus), A/Switzerland/9715293/2013 (H3N2), B/Phuket/3073/2013 (B/Yamagata/16/88 lineage), and B/Brisbane/60/2008 (B/Victoria/2/87 lineage). Each 0.2 mL dose also contains 0.188 mg/doseonosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin ( < 0.24 mcg/dose), and may also contain residual amounts of gentamicin sulfate ( < 0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA)( < 0.37 mcg/dose). FluMist Quadrivalent contains no preservatives.
The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist Quadrivalent is a colorless to pale yellow suspension and is clear to slightly cloudy.
What are the possible side effects of influenza virus nasal vaccine (FluMist 2012-2013)?
Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you will need to tell the doctor if the...
What are the precautions when taking influenza virus vaccine (FluMist)?
Before receiving this vaccine, tell the health care professional if you are allergic to eggs; or if you have previously had a severe allergic reaction to flu vaccine; or if you have any other allergies. This product may contain inactive ingredients (such as gentamicin, gelatin, arginine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before receiving this vaccine, tell the health care professional your medical history, especially of: breathing problems (e.g., asthma, wheezing, chronic lung disease), current infection/fever, diabetes, history of Guillain-Barre syndrome, immune system problems (e.g., due to cancer treatment, HIV infection), kidney disease.
This vaccine contains a weakened form of the flu virus. After...
Last reviewed on RxList: 11/3/2015
This monograph has been modified to include the generic and brand name in many instances.
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