Decision

Regulatory approval of COVID-19 Vaccine AstraZeneca

Information for healthcare professionals and the public about the COVID-19 Vaccine AstraZeneca.

Documents

Details

Information about the COVID-19 Vaccine AstraZeneca, approved by the MHRA on 30 December 2020.

The Information for healthcare professionals document 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.

The Information for UK recipients document provides information for patients on using the medicine safely. This is based on the Information for healthcare professionals of the product.

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.

Find out more about the approval from our press release.

For further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI).

Ingredients

The MHRA can confirm that the COVID-19 Vaccine AstraZeneca 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 Information for Healthcare Professionals of COVID-19 Vaccine AstraZeneca.

A full list of ingredients for the excipient composition of the vaccine can be found at point 6.1 in the Information for Healthcare Professionals of COVID-19 Vaccine AstraZeneca.

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 Information for Recipients of COVID-19 Vaccine AstraZeneca.

Published 30 December 2020
Last updated 7 April 2021 + show all updates
  1. Updated the Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca, with new information about extremely rare, unlikely to occur blood clots.

  2. All documents were updated to include updated side effect frequency and efficacy data, including a new table on efficacy by dosing interval in the Information for UK Healthcare Professionals document. A new Annex (Annex 1: Addition of manufacturer and importer) was added to the Conditions of Authorisation document.

  3. Published new versions of the Conditions of Authorisation documents, with an additional clause relating to off-label prescribing

  4. Published a new version of the Information for UK healthcare professionals, adding new information in Section 6.6 allowing for an additional dose to be taken if there is sufficient for a further full dose to be taken from the vial.

  5. Added an accessible HTML version of the summary of the Public Assessment Report

  6. Publication of Public Assessment Report for AztraZeneca COVID-19 vaccine

  7. First published.