• Safety Study Of Live, Oral Human Rotavirus Vaccine

    By

    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.

  • Rotavirus Vaccine

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    MANUFACTURER: GlaxoSmithKline Biologicals

    PROPER NAME:​​ Rotavirus Vaccine, Live, Oral

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Dextran,​​ Dulbecco’s Modified Eagle Medium​​ (sodium chloride,​​ potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red), sorbitol, sucrose, calcium carbonate, sterile water, xanthan [Porcine circovirus type 1 (PCV-1) is present in Rotarix. PCV-1 is not known to cause disease in humans.]

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Vero cells, porcine-derived materials, amino acids, dextran, Dulbecco’s Modified Eagle Medium (sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride,​​ sodium hydrogenocarbonate, phenol red), sorbitol, sucrose.

    TRADE NAME:​​ Rotarix

    Package Insert – Rotarix

    Vaccine Ingredients

  • Rotavirus Vaccine

    By

    MANUFACTURER: Merck & Co., Inc.

    PROPER NAME: ​​Rotavirus Vaccine, Live, Oral, Pentavalent

    VACCINE INGREDIENTS (not in order of quantity; see package insert for quantities): Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide,​​ polysorbate 80, cell culture media,​​ fetal bovine serum​​ [DNA from porcine circoviruses (PCV) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 are not known to cause disease in humans.]

    Substances used to create and grow the vaccine, which may or may not appear in the final product: Vero cells, buffered stabilizer,​​ porcine-derived material.

    TRADE NAME:​​ RotaTeq

    Package Insert – RotaTeq

    Vaccine Ingredients

  • Safety Study of Live, Oral Human Rotavirus Vaccine

    By

    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.