Safety Study of Live, Oral Human Rotavirus Vaccine

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.

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