GSK Rotarix Dosing and Administration Wheel (Rotarix Wheel) ERRORS

GSK has advised that some copies of the GSK Rotarix Dosing and Administration Wheel (Rotarix Wheel) contain errors. All providers are advised to stop using the Rotarix Wheel and discard any copies.

There is no issue with Rotarix vaccine itself, or the recommended schedule for administration as per the NIP or Handbook, just the Rotarix Wheel printed resource.

The below email has been sent to GPs from GSK

16th January 2023

Rotarix Dosing and Administration Wheel – discrepancy in date estimate
Dear Healthcare Professional,

GSK is committed to providing resources to healthcare professionals (HCPs) to support the quality use of our medicines and vaccines. Rotarix (human rotavirus, live attenuated oral vaccine) is indicated for the prevention of rotavirus gastroenteritis.

It has come to GSK’s attention that discrepancies have been noticed in some copies of the Rotarix Dosing and Administration Wheel (Rotarix Wheel). An image of the Rotarix Wheel is included below for reference. GSK recommends that HCPs immediately cease use of the Rotarix Wheel and discard any copies currently in their possession. In 2023, GSK intends to refresh the aids it provides to immunisers to assist with dosing and administration of Rotarix.

Please note: There is no impact to the quality of the Rotarix vaccine, this letter relates solely to the Rotarix Wheel, which is collateral distributed separately from the Rotarix vaccine.

As stated in the Rotarix Product Information, the vaccination course consists of two doses. The first dose should be given between 6 and 14 weeks of age. The interval between the two doses should not be less than 4 weeks. The vaccine course should be completed by the age of 24 weeks as safety has not been assessed in older children. This dosing schedule aligns with the current National Immunisation Program (NIP) schedule with the first dose being administered at 2 months of age and the second dose being administered at 4 months of age. Dosing schedule recommendations from both the Rotarix Product Information and NIP have been correctly printed on the Rotarix Wheel for the HCP’s reference.

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109.

Yours Sincerely,

Vincent So
Head of NIP Vaccines Business
GSK

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