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)

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)

Updated the Reg 174 information for Healthcare professionals and UK recipients

Updated summary of product characteristics and package leaflet information for Vaxzevria

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

Updated information for healthcare professionals and for patients

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.

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

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

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.

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.

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.

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

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.

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

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.

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

Publication of Public Assessment Report for AztraZeneca COVID-19 vaccine

First published.