H1N1 vaccine package insert

From the FDA website, here's a link to the package insert information for the H1N1 vaccine.

This is information from the manufacturer, Novartis, not from an anti-vaccine group. If you're thinking of getting the vaccine, I think you ought to read it, and discuss it with your doctor, rather than just lining up at the Target or the Minute Clinic for your shot.

Some highlights:

  • Multidose vial, 5-mL. Contains thimerosal, a mercury derivative (25 mcg mercury per 0.5-mL dose).

  • CONTRAINDICATIONS
    • History of systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations. (4, 11)

  • USE IN SPECIFIC POPULATIONS

    • Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine have not been established in pregnant women, nursing mothers or children less than 4 years of age. (8.1, 8.3, 8.4)

    • Antibody responses to the trivalent seasonal Influenza Virus Vaccine manufactured by Novartis (FLUVIRIN) were lower in the geriatric population than in younger subjects. (8.5)

  • 4 CONTRAINDICATIONS

    4.1 Hypersensitivity

    Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or
    who has had a life-threatening reaction to previous influenza vaccinations [see DESCRIPTION (11)].

    5 WARNINGS AND PRECAUTIONS

    5.1 Guillain-Barré Syndrome
    If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks.

    5.2 Altered Immunocompetence
    If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

    5.3 Preventing and Managing Allergic Reactions

    Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent Vaccine, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the
    vaccine.

  • I especially suggest a look at Table 3, "Adverse Events Reported by at least 5% of Subjects in Clinical Trials since 1998", not copied here.
  • 6.4 Other Adverse Reactions Associated with Influenza Vaccination

    Anaphylaxis has been reported after administration of FLUVIRIN. Although FLUVIRIN and Influenza A (H1N1) 2009 Monovalent Vaccine contain 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 [see CONTRAINDICATIONS
    (4)].

    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 polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

  • 8.1 Pregnancy

    Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN. It is also not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or FLUVIRIN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

    8.3 Nursing Mothers

    It is not known whether FLUVIRIN or Influenza A (H1N1) 2009 Monovalent Vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric subjects below the age of 4 years have not been established.

  • Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titers post-vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness. In some human studies, antibody titer of ≥1:40 have been associated with protection from influenza illness in up to 50% of
    subjects [see REFERENCES (15.2, 15.3)].

    Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.

    Here's a nice explanation of what the heck "hemagglutination inhibition (HI) antibody titers" are. As for the statement that "Global surveillance of influenza identifies yearly antigenic variants," that's one of the big problems with the seasonal flu vaccine: for the vaccine to be useful, they have to guess in advance which variants are going to be prevalent. You might remember how they got it wrong last year.

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Comments

Shingles and death after H1N1 vaccination in 85 y.o. woman

I know of an 85y.o. woman in fairly good health for that age who came down with a severe case of Shingles the day after administration of H1N1 vaccination, was sent to ICU 4 days later and died by the 10th day. Is anyone collecting these types of reactions yet?

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