Regulatory approval of Spikevax bivalent Original/Omicron booster vaccines
Information for healthcare professionals and the public on Moderna's bivalent vaccines. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below)
Documents
Details
The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice This follows careful review of the safety data by the MHRA and advice from the government’s independent Commission on Human Medicines. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis.
The product information for the Spikevax original COVID-19 vaccine (formerly COVID-19 Vaccine Moderna) can be found on a separate page.
Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland.
The information for healthcare professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available. Please regularly check this information as it is often updated.
The Public Assessment Report will be published shortly.
Summary of Product Characteristics
This is a description of a medicinal product’s properties and the conditions attached to its use. It explains how to use and prescribe a medicine. It is used by healthcare professionals, such as doctors, nurses and pharmacists.
Patient Information Leaflet
The Patient Information Leaflet provides information for patients on using the medicine safely. This is based on the Summary of Product Characteristics of the product.
Public Assessment Report
The Public Assessment Report is a scientific report, written by the MHRA. It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.
Last updated 17 April 2024 + show all updates
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Updated the SmPC and PIL to include chronic urticaria as a possible side effect. (Revised text 19 March 2024).
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Updated SmPCs for single dose and multi dose vials (there are no changes to the PIL): • Update 4.4 to remove the warning about use in immunocompromised individuals • Update 4.8 to include safety data in organ transplant recipients • Update 5.2 to include immunogenicity data in organ transplant recipients
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- Update to SmPC and PIL text on myocarditis and pericarditis - Update to SmPC text on use in immunocompromised individuals - Update to SmPC and PIL to include mechanical urticaria as an adverse event
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Updated 'Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 multi-dose vial' & 'Summary of Product Characteristics bivalent Original/Omicron BA.4/5 multi-dose vial ' to reflect extension to children from 6 months of age and new posology for primary immunisation. Updates apply from 1/8/23.
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Summary of Product Characteristics and Patient Information Leaflet updated following a variation to change the shelf-life of the product for Spikevax bivalent BA.1 Original/Omicron.
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An extension of indication to children aged 6 to 11 years old has just been granted. SmPC and PIL PDFs updated.
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Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine.
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- Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) - Update the SmPC and PIL to include urticaria as an adverse event - Update the SmPC and PIL to include extensive swelling of the vaccinated limb as an adverse event - Update the SmPC and PIL to include heavy menstrual bleeding as an adverse event - Minor change to SmPC text on myo/pericarditis
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Added Public Assessment Report
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First published.