What is in the H1N1 vaccine and is it safe for children and pregnant women?

October 29, 11:35 PMTampa Wellness ExaminerTracy Woolrich, RN HHP

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All H1N1 Flu Vaccines are not made equal. They are ALL listed as Pregnancy Category C however.

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All H1N1 Flu Vaccines are not made equal. However, they are ALL listed as Pregnancy Category C. Some of the vaccines are suitable for children and some are not. Some are suitable for adults over 50 and some are not. Many have mercury but some do not. Some flu vaccines contain deactivated virus, allowing for the shedding of virus to family members while others are made with killed virus. Do you know the difference? If not, you should learn before you go. Do your research. Know the ingredients in the vaccines and see if you have an allergy to any of them. Know the difference between the injectable and nasal mist form of administration.

I have highlighted some of the more common H1N1 Vaccines and have included links at the bottom of the page to the H1N1 Vaccine Packages’ Inserts from the major manufactures that include the ingredients and warnings. I have also included links to an article that includes ingredients to all vaccines and possible allergies. Be an informed consumer.

GlaxoSmithKline Flurarix 2009-2010 Formula (Injection)

FORMULATION: FLUARIX is formulated without preservatives and does not contain thimerosal (mercury). Each dose contains octoxynol-10, α-tocopheryl hydrogen succinate, and polysorbate 80. It may also contain residual amounts of hydrocortisone, gentamicin sulfate, ovalbumin, formaldehyde, and sodium deoxycholate.

INDICATION: FLUARIX is an inactivated influenza virus vaccine and is indicated for active immunization of adults (18 years of age and older) against influenza disease caused by influenza virus types A and B contained in the vaccine. FLUARIX IS NOT INDICATED FOR USE IN CHILDREN.

CONTRAINDICATIONS: FLUARIX should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins or to any component of FLUARIX. FLUARIX should not be given to individuals with bleeding disorders such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefit clearly outweighs the risk of administration.

PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with FLUARIX. It is not known whether FLUARIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUARIX should be given to a pregnant woman only if clearly needed.

Sanofi Pasteur 1 Influenza A (H1N1) 2009 Monovalent Vaccine

FORMULATION: Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine. It contains allantoic fluid, formaldehyde, sucrose, polyethylene glycol p-isooctylphenyl ether, sodium phosphate-buffered isotonic sodium chloride solution and gelatin. There is no thimerosal (mercury) used in the manufacturing process of the single-dose presentations. The multi-dose presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.

INDICATION: Influenza A (H1N1) 2009 Monovalent Vaccine is indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

PREGNANCY: Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. 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.

Novartis FLUVIRIN Influenza A (H1N1)

FORMULATION: FLUVIRIN® contains neomycin and polymyxin. The surface antigens, nonylphenol ethoxylate are removed. The prefilled syringe presentation is formulated without preservative. However, thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification. The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts ovalbumin, polymyxin, neomycin, betapropiolactone and nonylphenol ethoxylate.

INDICATION: FLUVIRIN® is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B. FLUVIRIN® is not indicated for children less than 4 years of age.

PREGNANCY: Pregnancy Category C: Animal reproduction studies have not been conducted with FLUVIRIN®. It is also not known whether FLUVIRIN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUVIRIN® should be given to a pregnant woman only if clearly needed.
 

Intranasal Spray MedImmune A-H1N1 Vaccine

FORMULATION: Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer contains a single 0.2 mL dose of the live attenuated influenza virus. Each dose also contains monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin sulfate. The vaccine contains no preservatives.

INDICATIONS AND CONTRAINDICATIONS: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus. It should not be given to individuals with hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine. It should be avoided in children and adolescents that are taking aspirin. Intranasal or FluMist should not be administered to any individuals with asthma or children < 5 years of age with wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefit outweighs the potential risk.

PREGNANCY: Pregnancy Category C. Animal reproduction studies have not been conducted with Monovalent Vaccine Live, Intranasal or FluMist. It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

AGE LIMITS: Intranasal is not approved for use in individuals over 50 years of age.

TRANSMISSION:  FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients. During studies, at least one vaccine strain was isolated from 80% of FluMist recipient. Strains were recovered from 1-21 days post vaccination. This means there is potential for shedding of virus for a period of 21 days post nasal vaccine administration.

POPULAR FLU PREPARATION INSERTS:

FLUARIX 2009 Latest Package Insert

CSL 2009 Latest Afluria Package Insert

GlaxoSmithKline Flurarix 2009-2010 Formula (Injection) Insert

Sanofi Pasteur 1Influenza A (H1N1) 2009 Monovalent Vaccine Insert

Novartis FLUVIRIN Latest 2009 Package Insert

Intranasal Spray MedImmune A-H1N1 Vaccine Insert

OTHER FLU REFERENCES:

Flu Shot may not help children and could increase risk in asthmatics

Individual Vaccine Ingredients