The Health Vine

WARNINGS IN CSL PACKAGING ABOUT SWINE FLU VACCINE

Download full document here:  Influenza A (H1N1) 2009 Monovalent Vaccine

EXCERPTS:

"Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccine manufactured by CSL (AFLURIA®). CSL’s Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA...."

" Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine the optimal dosage, number of doses and schedule."

" Influenza A (H1N1) 2009 Monovalent Vaccine is supplied in two presentations:

  • 0.5 mL preservative-free, single-dose, pre-filled syringe.
  • 5 mL multi-dose vial containing ten doses. Thimerosal, a mercury derivative, is added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

CONTRAINDICATIONS

Influenza A (H1N1) 2009 Monovalent Vaccine is contraindicated in individuals with known hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or in anyone who has had a life-threatening reaction to previous influenza vaccination.

WARNINGS AND PRECAUTIONS

Guillain-Barré Syndrome (GBS)

If GBS has occurred within 6 weeks of previous influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine 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 Reactions

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 individuals...

Overall Adverse Reactions

Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA.

The most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA were tenderness, pain, redness, and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

Safety Experience from Clinical Studies

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in the clinical studies of another vaccine and may not reflect the rates observed in clinical practice...

... The adverse reactions described have been included in this section because they:

1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically;

2) are potentially serious; or

3) have been reported frequently. The following adverse reactions also include those identified during postapproval use of AFLURIA outside the US since 1985.

Blood and lymphatic system disorders
Transient thrombocytopenia

Immune system disorders
Allergic reactions including anaphylactic shock and serum sickness

Other Adverse Reactions Associated With Influenza Vaccination

Anaphylaxis has been reported after administration of AFLURIA...

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...

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.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines 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.

Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA 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.

Pediatric Use

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in children. Safety and effectiveness in the pediatric population have not been established.

CLINICAL PHARMACOLOGY

Specific levels of HI antibody titers post-vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza virus.

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.

NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

CLINICAL STUDIES

No controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA have been performed.

(Ed:  Notice in the document's cited studies with Alfluria to test for side effects that their control group received a thimerosal-containing (mercury derivative) placebo.  Is it good science to contaminate the placebo group with the antagonist linked to autism and other neurological side effects - mercury?)