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AZD1222 FDA Approval Status

Last updated by Judith Stewart, BPharm on Feb 15, 2021.

FDA Approved: No
Brand name: AZD1222
Generic name: SARS-CoV-2 vaccine
Previous Name: ChAdOx1 nCoV-19
Company: AstraZeneca
Treatment for: Prevention of COVID-19

AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19.

More information

Development timeline for AZD1222

Jan 13, 2022New Vaxzevria Data Further Support its Use as Third Dose Booster
Dec 23, 2021Vaxzevria Significantly Boosted Antibody Levels Against Omicron
Jul 23, 2021Vaxzevria is Highly Effective After One Dose Against Severe Disease or Hospitalisation Caused by Beta and Delta Variants of Concern
Jun 28, 2021Vaxzevria Induced Immunity for at Least One Year Following a Single Dose and Strong Immune Responses Following Either a Late Second Dose or a Third Dose
Jun 15, 2021COVID-19 Vaccine AstraZeneca Effective Against Delta (‘Indian’) Variant
May 21, 2021AstraZeneca COVID-19 Vaccine Vaxzevria Authorised for Emergency Use in Japan
Mar 25, 2021AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy
Mar 22, 2021AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis
Mar 18, 2021UK and EU Regulatory Agencies Confirm COVID-19 Vaccine AstraZeneca is Safe and Effective
Mar 14, 2021Update on the Safety of COVID-19 Vaccine AstraZeneca
Mar  2, 2021AstraZeneca Advances Mass Global Rollout of COVID-19 Vaccine Through COVAX
Feb 15, 2021AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization
Feb  3, 2021COVID-19 Vaccine AstraZeneca Confirms 100% Protection Against Severe Disease, Hospitalisation and Death in the Primary Analysis of Phase III Trials
Jan 29, 2021COVID-19 Vaccine AstraZeneca Authorised for Use in the EU
Jan 29, 2021COVID-19 Vaccine AstraZeneca Recommended for Use in the EU
Jan  6, 2021Serum Institute of India Obtains Emergency Use Authorisation in India for AstraZeneca’s COVID-19 Vaccine
Dec 30, 2020AstraZeneca’s COVID-19 Vaccine Authorised for Emergency Supply in the UK
Dec  8, 2020AZD1222 Oxford Phase III Trials Interim Analysis Results Published in The Lancet
Nov 23, 2020AZD1222 Vaccine Met Primary Efficacy Endpoint in Preventing COVID-19
Oct 23, 2020FDA Authorises Restart of the COVID-19 AZD1222 Vaccine US Phase III Trial
Oct  2, 2020COVID-19 Vaccine AZD1222 Clinical Trial Resumed in Japan, Follows Restart of Trials in the UK, Brazil, South Africa and India
Sep 12, 2020COVID-19 Vaccine AZD1222 Clinical Trials Resumed in the UK
Sep  9, 2020Statement on AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause
Aug 31, 2020AstraZeneca’s Scientific and Social Commitment for COVID-19 Vaccine AZD1222
Aug 31, 2020Development of COVID-19 Vaccine AZD1222 Expands into US Phase III Clinical Trial Across All Adult Age Groups
Aug 19, 2020AstraZeneca Australia & New Zealand Response to the COVID-19 Pandemic
Aug 14, 2020AstraZeneca Concludes Agreement with the European Commission for the Supply of up to 400 Million Doses of AZD1222 COVID-19 Vaccine
Jul 20, 2020COVID-19 Vaccine AZD1222 Showed Robust Immune Responses in All Participants in Phase I/II Trial
Jun 16, 2020Cobra Signs Supply Agreement with AstraZeneca for Manufacture of COVID-19 Vaccine Candidate
Jun 13, 2020AstraZeneca to Supply Europe With Up To 400 Million Doses of Oxford University’s COVID-19 Vaccine At No Profit
Jun  4, 2020AstraZeneca Takes Next Steps Towards Broad and Equitable Access to Oxford University’s COVID-19 Vaccine
May 21, 2020AstraZeneca Advances Response to Global COVID-19 Challenge as it Receives First Commitments for Oxford’s Potential New Vaccine
May 15, 2020Investigational ChAdOx1 nCoV-19 Vaccine Protects Monkeys Against COVID-19 Pneumonia
Apr 30, 2020AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine

Further information

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