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Regulatory approval of COVID-19 Vaccine AstraZeneca

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

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
30 December 2020
Last updated:
22 November 2023
Show all updates

  1. - Update to section 4.4 of the SmPC and section 2 of the PIL text to include a warning about acute disseminated encephalomyelitis (ADEM) - Update to section 4.8 of the SmPC and section 4 of the PIL to revise the frequency of the possible side effects dizziness, pyrexia and abdominal pain - Update to sections 4.8 and 5.1 of the SmPC regarding updated analyses for clinical studies

  2. Summary of Product Characteristics & Patient Information Leaflet updated to reflect: - Update to sections 4.2,4.4, 4.8 and 5.1 regarding homologous booster - Update to section 4.8 paraesthesia, hypoesthesia and cutaneous vasculitis - Update to section 6.3 to extend self-life to 9 months

  3. Public Assessment Report updated. You may receive a third (booster) injection of Vaxzevria. 'How is Vaxzevria used?' section updated to reflect: "The booster injection may be given at least 6 months after the second injection". And section 'What benefits of Vaxzevria have been shown in studies?' updated to reflect: Booster - "In a small sub-study, a third dose booster of Vaxzevria given 28 to 38 weeks after the second dose was shown to induce higher levels of antibodies, including against the Beta and Delta variants, compared to those achieved after the second dose. The booster was also responsible for maintaining Spike-specific T-cell responses."

  4. Updated the SmPC and PIL documents to add tinnitus as an uncommon side effect

  5. Updated the HTML and PDF versions of the Public Assessment Report

  6. Renewal of the conditional marketing authorisation Updated efficacy and immunogenicity data (SPC section 5.1) Updated preclinical data (SPC sections 4.6 and 5.3 and package leaflet information) Updated frequency of thrombocytopenia (SPC section 4.8 and package leaflet information)

  7. SPC updated: Neurological Events section: Extremely rare cases of transverse myelitis have been reported following Vaxzevria. A further dose of Vaxzevria should not be given to those who have experienced symptoms of transverse myelitis after a previous dose of this vaccine PIL Updated: Transverse Myelitis (inflammation of the spinal cord) added to "warnings and precautions" "Not Known" side effect added: inflammation of the spinal cord which may cause muscle weakness, localised or radiating back pain, bladder and bowel symptoms and changes in sensation (transverse myelitis)

  8. Updated the Reg 174 information for Healthcare professionals and UK recipients

  9. Updated summary of product characteristics and package leaflet information for Vaxzevria

  10. Added Guillain-Barré syndrome [GBS] as a very rare side effect.

  11. Updated information for healthcare professionals and for patients

  12. Updated sections of Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca (Regulation 174) and Information for UK recipients on COVID-19 Vaccine AstraZeneca (Regulation 174) to include information about receiving a third dose. Also updated the Regulation 174 Conditions document with additional pharmacovigilance conditions.

  13. Updated the PIL and Spc to include new warning on Guillaine-Barre Syndrome

  14. Added Lay summary, Vaxzevria (previously COVID‑19 Vaccine AstraZeneca, suspension for injection) COVID-19 Vaccine (ChAdOx1‑S [recombinant])

  15. Updated to reflect the addition of capillary leak syndrome as a contraindication. Also changed the name of the COVID-19 Vaccine AstraZeneca in the Conditional Marketing Authorisation product information to the brand name - Vaxzevria.

  16. A Summary of Product Information, a Patient Information Leaflet and a Conditions of Authorisation for COVID-19 Vaccine AstraZeneca Conditional Marketing Authorisation have been added as the MHRA has issued a Conditional Marketing Authorisation for the vaccine. Updated versions of the Information for healthcare professionals and Information for UK recipients documents have also been added.

  17. Updated the Information for Healthcare Professionals and Information for UK Recipients on COVID-19 Vaccine AstraZeneca with new information about extremely rare, unlikely to occur blood clots.

  18. Updated the Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca, with new information about extremely rare, unlikely to occur blood clots.

  19. 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.

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

  21. 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.

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

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

  24. First published.

Documents

Summary of Product Characteristics for Vaxzevria - Last updated November 2023

HTML

Summary of Product Characteristics for Vaxzevria - Last updated November 2023

PDF, 89.3 KB, 20 pages

Patient Information Leaflet for Vaxzevria - Last updated November 2023

HTML

Patient Information Leaflet for Vaxzevria - Last updated November 2023

PDF, 150 KB, 7 pages

Conditions of Authorisation for Vaxzevria - Last updated June 2023

HTML

Conditions of Authorisation for Vaxzevria - Last updated June 2023

PDF, 42.1 KB, 1 page

This file may not be suitable for users of assistive technology.

Request an accessible format
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Public Assessment Report (PAR) for Vaxzevria - last updated 03/23

PDF, 999 KB, 70 pages

This file may not be suitable for users of assistive technology.

Request an accessible format
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Summary of the Public Assessment Report (PAR) for Vaxzevria - last updated 03/23

HTML

ARCHIVE: Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca (Regulation 174)

HTML

ARCHIVE: Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca (Regulation 174)

PDF, 189 KB, 16 pages

ARCHIVE: Information for UK recipients on COVID-19 Vaccine AstraZeneca (Regulation 174)

HTML

ARCHIVE: Information for UK recipients on COVID-19 Vaccine AstraZeneca (Regulation 174)

PDF, 147 KB, 8 pages

ARCHIVE: Conditions of Authorisation for COVID-19 Vaccine AstraZeneca (Regulation 174)

HTML

ARCHIVE: Conditions of Authorisation for COVID-19 Vaccine AstraZeneca (Regulation 174)

PDF, 267 KB, 11 pages

Details

On 24 June 2021, the MHRA issued a Conditional Marketing Authorisation (CMA) for COVID-19 Vaccine AstraZeneca in Great Britain (GB). A CMA issued by the European Medicines Agency has had effect in Northern Ireland since 29 January 2021. To date, supply of the AstraZeneca vaccine in the UK has been authorised on a temporary basis by the MHRA under Regulation 174 of the Human Medicine Regulations 2012, but as this was always intended to be a temporary arrangement, supply of this vaccine will change to be in accordance with the CMAs.

Manufacture of the vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.

The information for healthcare professionals and UK recipients on using the vaccine safely has been periodically updated as new data have become available and this will continue under the CMA. Please regularly check this information as it is often updated.

The COVID-19 Vaccine AstraZeneca authorised under Regulation 174 remains in use and its product information has been updated in line with the product information of the GB CMA.

The MHRA regularly publishes reports of the safety of the COVID-19 vaccines.

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

Summary of Product Characteristics (CMA)/Information for Healthcare Professionals (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 (CMA)/Information for UK Recipients (R174)

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 (PAR) is a scientific report, written by the MHRA. 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.

Ingredients

The MHRA can confirm that 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 Summary of Product Characteristics (CMA) and the Information for Healthcare Professionals (R174).

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 (CMA) and the Information for Healthcare Professionals (R174).

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 Summary of Product Characteristics (CMA) and the Information for Healthcare Professionals (R174).

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