Wednesday, September 16, 2009

Package Insert: Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)


Sarasota for Vaccination Choice Comment:
Read the fine print, the devil is in the details?

NOTE: This is the only INTRANASAL H1N1 vaccine approved by FDA on Sept. 15, 2009. FDA also approved three INJECTABLE vaccines.



Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is a live monovalent vaccine for administration by intranasal spray. The influenza virus strain in Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is (a) cold-adapted (ca) (i.e., it replicates efficiently at 25oC, a temperature that is restrictive for replication of many wild-type influenza viruses); (b) temperature-sensitive (ts) (i.e., it is restricted in replication at 39oC, a temperature at which many wild-type influenza viruses grow efficiently); and (c) attenuated (att) (it does not produce classic influenza-like illness in the ferret model of human influenza infection). The cumulative effect of the antigenic properties and the ca, ts, and att phenotypes is that the attenuated vaccine virus replicates in the nasopharynx to induce protective immunity.

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 Studies (14.5)]. For the reassortant virus in Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, 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 pandemic (H1N1) 2009 wild-type virus. Thus, the virus contained in Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, maintains the replication characteristics and phenotypic properties of the MDV and expresses the HA and NA of the pandemic (H1N1) 2009 virus. For the MDV, at least five
genetic loci in three different internal gene segments contribute to the ts and att phenotypes; five genetic loci in three gene segments control the ca property.

Specific pathogen-free (SPF) eggs are inoculated with the reassortant strain 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 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 are diluted as required to attain the desired potency with stabilizing buffers. The bulk vaccine is then filled directly into individual sprayers for nasal administration.

Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of the live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus: A/California/7/2009 (H1N1)v. Each 0.2 mL dose also contains 0.188 mg/dose monosodium 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, 0.96 mg/dose monobasic potassium phosphate, and <0.015 mcg/mL gentamicin sulfate. The vaccine 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. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is a colorless to pale yellow liquid and is clear to slightly cloudy.

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