Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

Withdrawn

This medicine's authorisation has been withdrawn

COVID-19 Vaccine (ChAdOx1-S [recombinant])

Overview

On 27 March 2024, the European Commission withdrew the marketing authorisation for Vaxzevria (COVID 19 Vaccine (ChAdOx1 S [recombinant])) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Vaxzevria was granted conditional marketing authorisation in the EU on 29 January 2021 for active immunisation against coronavirus disease 2019 (COVID-19). The conditional marketing authorisation was switched to a standard marketing authorization, valid for 5 years, on 31 October 2022. 

The European Public Assessment Report (EPAR) for Vaxzevria is updated to indicate that the marketing authorisation is no longer valid.

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Medicine overview

Reference Number: EMA/609262/2021

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Risk-management-plan

Product information

Vaxzevria : EPAR - Product information

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - All authorised presentation

Product details

• Name of medicine:
  Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
• Active substance:
  ChAdOx1-SARS-COV-2
• International non-proprietary name (INN) or common name:
  COVID-19 Vaccine (ChAdOx1-S [recombinant])
• Therapeutic area (MeSH):
  COVID-19 virus infection
• Anatomical therapeutic chemical (ATC) code:
  J07BN02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/005675
• Marketing authorisation holder:
  AstraZeneca AB

  151 85 Sodertalje; Sweden

• Opinion adopted:
  29/01/2021
• Marketing authorisation issued:
  29/01/2021
• Withdrawal of marketing authorisation:
  27/03/2024
• Revision:
  32

Assessment history

Changes since initial authorisation of medicine

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Procedural steps taken and scientific information after authorisation

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/317895/2023

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202206: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/38839/2023

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0079 : EPAR - Assessment report - Renewal

AdoptedReference Number: EMA/865685/2022

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/666408/2022

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-II-0052 : EPAR - Assessment report - Variation

AdoptedReference Number: EMA/351687/2022

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0037 : EPAR - Assessment report - Renewal

AdoptedReference Number: EMA/622071/2021

Initial marketing authorisation documents

Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Public assessment report

AdoptedReference Number: EMA/94907/2021

CHMP summary of positive opinion for COVID-19 Vaccine AstraZeneca

AdoptedReference Number: EMA/57617/2021