Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).
There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.
Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent suspension.
Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine.
All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex.
INDICATIONS AND USAGE
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
DOSAGE AND ADMINISTRATION
Preparation for Administration
Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.
Shake the syringe and single-dose vials well before administering the vaccine and shake the multi-dose vial each time before withdrawing a dose of vaccine.
Recommended Dose and Schedule
Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine the optimal dosage, number of doses and schedule.
Available data show that children 9 years of age and younger are largely serologically naive to the pandemic (H1N1) 2009 virus. (1) Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as follows:
Children
Children 6 through 35 months of age should receive two 0.25 mL intramuscular doses approximately 1 month apart.
The vaccine should not be injected into the gluteal region or into areas where there may be a major nerve trunk.
DOSAGE FORMS AND STRENGTHS
Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular injection.
Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in 4 presentations:
1) Prefilled syringe, 0.25 mL, no preservative, for 6 through 35 months of age; distinguished by a pink syringe plunger rod;
2) Prefilled syringe, 0.5 mL, no preservative, for 36 months of age and older;
3) Single-dose vial, 0.5 mL, no preservative, for 36 months of age and older;
4) Multi-dose vial, 5 mL, for 6 months of age and older, contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose contains 25 micrograms (mcg) mercury.
CONTRAINDICATIONS
Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine to anyone with a known severe hypersensitivity to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine. [See Warnings and Precautions (5) and Description (11)]
WARNINGS AND PRECAUTIONS
Guillain-Barre Syndrome
Recurrence of Guillain-Barre syndrome (GBS) has been temporally associated with the administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who have a prior history of Guillain-Barre syndrome should be based on careful consideration of the potential benefits and risks.
Altered Immunocompetence
If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
Preventing and Managing Allergic Reaction
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
Limitations of Vaccine Effectiveness
Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all recipients.
ADVERSE REACTIONS
Sanofi Pasteur’s Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone®) are manufactured by the same process. The following sub-sections summarize safety data from clinical experience with seasonal trivalent inactivated influenza vaccines, including Fluzone vaccine.
Clinical Trial Experience
Adverse event information from clinical trials provides the basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.
Children
The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults. No reported local or systemic reaction required a therapeutic intervention other than analgesics.
Post-Marketing Experience
The following additional events have been reported during post-approval use of Fluzone vaccine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.
Blood and Lymphatic System Disorders:
Thrombocytopenia, lymphadenopathy
Immune System Disorders:
Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
Nervous System Disorders:
GBS, convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
Vascular Disorders:
Vasculitis, vasodilation/flushing
Respiratory, Thoracic and Mediastinal Disorders:
Dyspnea, pharyngitis, rhinitis
Skin and Subcutaneous Tissue Disorders:
Stevens-Johnson syndrome
General Disorders and Administration Site Conditions:
Fever, pain, pruritis, asthenia/fatigue, pain in extremities, chest pain
Other Adverse Events Associated with Influenza Vaccines
Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis.
The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.
Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.
Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.
DRUG INTERACTIONS
Concomitant Administration with Other Vaccines
There are no data on the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine with seasonal trivalent influenza vaccines.
Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in the same syringe or vial.
If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered at different injection sites.
Immunosuppressive Therapies
If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, immunologic response may be diminished.
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