• Safety Study of Live, Oral Human Rotavirus Vaccine

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    The live, oral human rotavirus vaccine (RV1) has been licensed by the Food and Drug Administration (FDA) since 2008 and it is manufactured by GlaxoSmithKline Biologicals.

    This study was funded by a research contract between Optum and GlaxoSmithKline Biologicals S.A. and the purpose of the study was to monitor the safety of the RV1 vaccine as part of a regulatory commitment for post-licensure.  At the end of the study, they claimed that the RV1 is considered safe, even though there is an increased convulsion risk after Dose 1!

    Important items to note about this document:

    Manipulation of Data:

    This study claims that there was an increased convulsion following RV1 Dose 1, but that it is “inconclusive as it was observed in only one of the claims databases.  The IRR following RV1 Dose 1 in the SCCS analysis lacked precision (2.40, 95% CI: 0.73 – 7.86).”

    Conflicts of Interest:

    The people who conducted the study are all employees who either worked for Optum and hold shares/stocks in the parent company of Optum (UnitedHealth Group, Inc.) or employees who worked for GlaxoSmithKline and some hold shares in the GSK group of companies.  There are also employees who worked for HealthCore, Inc., and their employer received funding for conduct of the study sponsored by the GSK group of companies.

  • Influenza Vaccine (flu)

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    MANUFACTURER: Sanofi Pasteur,​​ Inc.

    PROPER NAME:​​ Influenza Virus Vaccine

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Formaldehyde, egg protein, octylphenol ethoxylate (Triton X-100), sodium phosphate- buffered isotonic sodium chloride solution,​​ Thimerosal​​ (multi-dose vials).

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Embryonated chicken eggs, allantoic fluid,​​ formaldehyde, linear sucrose density gradient solution, non-ionic surfactant Octylphenol Ethoxylate (Triton X-100), sodium phosphate-buffered isotonic sodium chloride solution.

    TRADE NAME:​​ Fluzone Quadrivalent

    Package Insert – Fluzone Quadrivalent

    Vaccine Ingredients

  • Influenza Vaccine (flu)

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    MANUFACTURER: ID Biomedical Corporation of Quebec

    PROPER NAME:​​ ​​ Influenza Virus Vaccine

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Ovalbumin,​​ formaldehyde, sodium deoxycholate, α-tocopheryl hydrogen succinate,​​ polysorbate 80,​​ Thimerosal ​​​​ (multi-dose vials),​​ phosphate-buffered saline solution.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Allantoic cavity of embryonated hens’ eggs, formaldehyde, sodium deoxycholate

    TRADE NAME:​​ FluLaval Quadrivalent

    Package Insert – FluLaval Quadrivalent

    Vaccine Ingredients

  • Influenza Vaccine (flu)

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    MANUFACTURER: Seqiris, Inc.

    PROPER NAME:​​ ​​ Influenza Vaccine

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Madin Darby Canine Kidney (MDCK) cell protein, phosphate buffered saline, protein other than HA,​​ MDCK cell DNA,​​ polysorbate 80,​​ cetyltrimethlyammonium bromide, and β- propiolactone,​​ Thimerosal​​ (multi-dose vials).

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Madin Darby Canine Kidney (MDCK) cells, B-propiolactone, cetyltrimethylammonium bromide, phosphate buffered saline.

    TRADE NAME:​​ Flucelvax (Quadrivalent)

    Package Insert – Flucelvax (Quadrivalent)

    Vaccine Ingredients

  • Influenza Vaccine (flu)

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    MANUFACTURER: Protein Sciences Corporation

    PROPER NAME:​​ Influenza Vaccine

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Sodium chloride, monobasic sodium phosphate,​​ dibasic sodium phosphate,​​ polysorbate 20​​ (Tween 20), baculovirus and Spodoptera frugiperda cell proteins, baculovirus and cellular DNA, Triton X-100.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: HA insect cell (fall armyworm, Spodoptera frugiperda) proteins, lipids, vitamins, amino acids, mineral salts, Triton X-100.

    TRADE NAME:​​ Flublok (Quadrivalent)

    Package Insert – Flublok (Quadrivalent)

    Vaccine Ingredients

  • Influenza Vaccine (flu)

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    MANUFACTURER: GlaxoSmithKline ​​ Biologicals

    PROPER NAME:​​ Influenza Virus Vaccine

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Octoxynol-10 (TRITON X-100), α-tocopheryl hydrogen succinate,​​ polysorbate 80 (Tween 80), hydrocortisone, gentamicin sulfate,​​ ovalbumin,​​ formaldehyde, sodium deoxycholate, sodium phosphate-buffered isotonic sodium chloride.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Embryonated chicken eggs, linear sucrose density gradient solution (containing detergent), sodium deoxycholate,​​ formaldehyde, sodium phosphate buffered isotonic sodium chloride solution.

    TRADE NAME:​​  Fluarix Quadrivalent

    Package Insert – Fluarix Quadrivalent

    Vaccine Ingredients

  • Influenza Vaccine (flu)

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    MANUFACTURER: Seqiris, Inc.

    PROPER NAME:​​ Influenza Vaccine, Adjuvanted

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Squalene,​​ polysorbate 80, sorbitan trioleate, sodium citrate dehydrate, citric acid monohydrate, neomycin, kanamycin, barium, hydrocortisone, egg proteins, cetyltrimethylammonium bromide (CTAB),​​ formaldehyde

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Allantoic cavity of embryonated hen’s eggs,​​ MF59C.1 adjuvant (MF59), formaldehyde, cetyltrimethylammonium bromide (CTAB)

    TRADE NAME:​​ Fluad (Trivalent)

    Package Insert – Fluad (Trivalent)

    Vaccine Ingredients

  • Hep A Vaccine (hepatitis A)

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    MANUFACTURER: Merck & Co.,​​ Inc.

    PROPER NAME:​​ Hepatitis A Vaccine, Inactivated

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Amorphous aluminum hydroxyphosphate sulfate, non-viral protein,​​ DNA,​​ bovine albumin,​​ formaldehyde, neomycin, sodium borate, sodium chloride, other process chemical​​ residuals.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Formalin,​​ amorphous aluminum hydroxyphosphate sulfate, formaldehyde, neomycin, MRC-5 fibroblasts

    TRADE NAME:​​ VAQTA

    Package Insert – VAQTA

    Vaccine Ingredients

  • Hep B Vaccine (hepatitis B)

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    MANUFACTURER: GlaxoSmithKline Biologicals

    PROPER NAME:​​ Hepatitis B Vaccine (Recombinant)

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Aluminum hydroxide, yeast protein, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Aluminum hydroxide.

    TRADE NAME:​​ Engerix-B

    Package Insert – Engerix-B

    Vaccine Ingredients

  • Hep B Vaccine (hepatitis B)

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    MANUFACTURER: Dynavax Technologies​​ Corporation

    PROPER NAME:​​ Hepatitis B Vaccine (Recombinant), Adjuvanted

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Yeast​​ protein, yeast DNA, deoxycholate, phosphorothioate linked oligodeoxynucleotide, sodium phosphate, dibasic dodecahydrate, sodium chloride, monobasic dehydrate,​​ polysorbate 80.

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Vitamins and mineral salts.

    TRADE NAME:​​ Heplisav-B

    Package Insert – Heplisav-B

    Vaccine Ingredients