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.
The MHRA has issued a Conditional Marketing Authorisation for Spikevax bivalent Original/Omicron booster vaccine in Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. If the European Medicines Agency grants a CMA for Spikevax bivalent Original/Omicron booster vaccine it would apply in Northern Ireland and the Regulation 174 authorisation would no longer be in place.
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 and this will continue when the CMA is converted to a MA. Please regularly check this information as it is often updated.
The Public Assessment Report will be published shortly.
Summary of Product Characteristics (also referred to as the Information for Healthcare Professionals under R174)
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.