Medicines Healthcare Products Regulatory Agency
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 governments 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. A temporary suspension will also apply for infants and children aged 6 months to 5 years, should this age group be included in the vaccination programme.
The product information for the following Spikevax vaccines can be found on the pages below:
The Summary of Product Characteristics is a description of a medicinal products 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.
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.
The Public Assessment Report (PAR) is a scientific report, written by the?MHRA and will be published shortly. It explains how this product was assessed and how its authorisation was recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use this product.
This new marketing authorisation granted by the MHRA is valid in Great Britain only and was approved via the national licensing route.
See further information in our news story.
Ingredients
The?MHRA?can confirm that Spikevax does not contain any components of animal origin.
A full list of ingredients for the qualitative and quantitative composition of the vaccine can be found at point 2 in the Summary of Product Characteristics.
A full list of ingredients for the excipient composition of the vaccine can be found at point 6.1 in the Summary of Product Characteristics.
A full list of ingredients for the qualitative and quantitative composition of the vaccine and a full list of the excipient composition of the vaccine can be found at point 6 in the Patient Information Leaflet.