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 25°C, 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 39°C, 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]. 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
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.
Last reviewed on RxList: 11/5/2009
This monograph has been modified to include the generic and brand name in many instances.