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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.

  • AZD1222 works by using a viral vector (ChAdOx1 - chimpanzee adenovirus Oxford 1) based on a weakened version of a common cold (adenovirus) virus that contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body, protecting it against COVID-19.
  • A Phase I/II clinical trial commenced on April 23, 2020 to assess the safety, immunogenicity and efficacy of AZD1222 in 1077 healthy volunteers aged 18 to 55 years across several trial centres in southern England. Interim results were published in The Lancet on July 20, 2020.
    • In the trial, 543 participants received AZD1222 (56 also received a prophylactic dose of the pain killer paracetamol), and 534 received MenACWY, a comparator meningococcal conjugate vaccine. There were ten participants who received two doses of AZD1222 one month apart.
    • The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose.
    • No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness.
    • Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). Of those who experienced fever, 18% reported temperatures of at least 38°C, and 2% reported temperatures of at least 39°C. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination.
  • Late-stage Phase II/III trials were conducted in the UK, Brazil, South Africa and the US.
  • Vaccine Maker Halts Trial Following Unexplained Illness in Volunteer September 9, 2020
    AstraZeneca COVID Vaccine Trial Restarts September 14, 2020
    Details Emerge on Unexplained Illness in AstraZeneca COVID Vaccine Trial September 18, 2020

More information

Development Timeline for AZD1222

DateArticle
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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