AZD1222 Vaccine Description
The AZD1222 coronavirus vaccine candidate, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.
Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus.
The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body, and causes COVID-19 disease.
By vaccinating with AZD1222 (ChAdOx1 nCoV-19), these researchers are hoping to make the body recognize and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection.
Vaccines made from the ChAdOx1 virus have been given to more than 320 people to date and have been shown to be safe and well-tolerated, although they can cause temporary side effects, such as temperature, headache, or a sore arm.
A preliminary report of the COV001/2 phase 1/2 study published on July 20, 2020, showed a single dose of AZD1222 resulted in a 4-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection.
The AZD1222 vaccine candidate has progressed into late-stage Phase II/III clinical trials in various countries. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
On August 31, 2020, the company said in a media statement: 'clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa and trials are planned to start in Japan and Russia. These trials, together with the US Phase III clinical trial will enroll up to 50,000 participants globally.
Clinical trials for AZD1222 resumed across the world on October 23, 2020, with regulators in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so.
Pascal Soriot, CEO of AstraZeneca said in a press statement: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”
If the vaccine is proven to be safe and effective, the first doses to be produced under this agreement are anticipated to be available in early 2021. Vaccines will be released on a rolling basis as production is completed, and the full quota of 300 million doses is expected to be available by July 2021.
On September 12, 2020, clinical trials for the AZD1222 resumed in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so.
Globally, about 18,000 individuals have received study vaccines as part of the trial, as of September 12, 2020.
The Oxford Vaccine Centre’s COVID-19 vaccine trial is being run by the Jenner Institute and Oxford Vaccine Group. The team, who started work on developing a coronavirus vaccine candidate to prevent COVID-19 disease, began on January 20, 2020. The AZD1222 vaccine was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries.
AZD1222 Vaccine Distribution Agreements
AstraZeneca reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy, and the Netherlands, to supply up to 400 million doses of the University of Oxford’s potential COVID-19 vaccine, that is currently in clinical development.
Similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance for 700 million doses, and it agreed on a license with the Serum Institute of India for the supply of an additional one billion doses, principally for low-and-middle-income countries.
On October 16, 2020, the Swiss federal government signed an agreement with AstraZeneca for the delivery of up to 5.3 million doses of vaccine, provided it successfully passes the clinical trial phase and is approved by Swissmedic.
AZD1222 Vaccine Indication
The ChAdOx1 nCoV-19 vaccine candidate is being tested in clinical trials to prevent infection of SARS-CoV-2 which causes COVID-19 disease.
AZD1222 Vaccine News
October 26, 2020 - “It is encouraging to see immunogenicity responses were similar between older and younger adults and that reactogenicity was lower in older adults, where the COVID-19 disease severity is higher,” an AstraZeneca spokesman told CNBC via email.
October 23, 2020 - The US Food and Drug Administration (FDA) authorized the restart of phase 3 clinical trial. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial. As part of the standard review process for trial safety events, a voluntary pause to vaccination across all global trials was triggered on September 6, 2020, to allow the examination of safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who also confirmed that the trials were safe to resume.
October 19, 2020 - Thailand Ministry of Public Health, Siam Bioscience, SCG, and AstraZeneca has signed a Letter of Intent on the manufacturing and supply of the University of Oxford’s potential COVID-19 vaccine AZD1222. With the aim of commencing the vaccination of the Thai population in the first half of 2021.
October 12, 2020 - Thailand's Ministry of Public Health, Siam Bioscience, SCG, and AstraZeneca signed a Letter of Intent on the manufacturing and supply of the University of Oxford’s potential COVID-19 vaccine AZD1222.
October 2, 2020 - The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussions with the Japanese Pharmaceuticals and Medical Devices Agency. Their recommendations have been supported by international regulators in the UK, Brazil, South Africa, and India who have deemed that the trials are safe to resume.
October 2, 2020 - Health Canada announced it received its first submission for authorization of a COVID-19 vaccine developed by AstraZeneca in partnership with the University of Oxford. In September 2020, the Minister of Health signed an Interim Order allowing companies to submit safety and efficacy data and information as they become available.
September 30, 2020 - The U.S. Food and Drug Administration is reported to have broadened its investigation of a serious illness in AstraZeneca's AZD1222 vaccine candidate study and will look at data from earlier trials of similar vaccines, developed by the same scientists, three sources familiar with the details exclusively told Reuters.
September 25, 2020 - Canada's Prime Minister, Justin Trudeau announced an agreement with AstraZeneca to procure up to 20 million doses of its COVID–19 vaccine candidate.
September 15, 2020 - AstraZeneca Plc announced it has begun enrolling adults for a U.S.-funded, 30,000-subject late-stage study of its high profile COVID-19 vaccine candidate. Trial participants will receive either two doses of the experimental vaccine, dubbed AZD1222, four weeks apart, or a placebo, the company said. This phase 3 trial is being conducted under the U.S. government’s Operation Warp Speed program, which aims to accelerate the development, manufacturing, and distribution of vaccines and treatments for COVID-19.
September 12, 2020 - AstraZeneca announced clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so. AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.
September 12, 2020 - Serum Institute of India announced phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate will resume after receiving the green signal from the Drugs Controller General of India.
September 10, 2020 - Pascal Soriot, AstraZeneca's CEO, told an online briefing organized by Tortoise Media that an independent safety committee was currently reviewing data on the AZD1222 vaccine candidates' reported adverse event. And 'the company should know before the end of 2020 whether this experimental vaccine protects people against the SARS-CoV-2 virus.'
September 9, 2020 - AstraZeneca announced 'As part of the ongoing randomized, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.
September 3, 2020 - As part of the US's Operation Warp Speed goal to deliver safe and effective vaccines and therapeutics by January 2021, five DoD locations have been identified to participate in the Phase III trial evaluating the vaccine candidate AZD1222 under development by AstraZeneca. Honorable Tom McCaffery, Assistant Secretary of Defense for Health Affairs said: “Now that vaccines have passed the first phases of testing for safety, dosing and response, we are ready to move into the next phase where volunteers are needed to join large clinical studies. We are excited to have several sites identified to support the next steps in the vaccine development process.”
September 1, 2020 - Oxford Biomedica plc announced that it has signed an 18 month supply agreement under a 3-year Master Supply and Development Agreement with AstraZeneca UK Ltd. for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period into 2022 and 2023 by mutual agreement.
August 31, 2020 - The National Institutes of Health announced a multi-site, Phase 3 clinical trial evaluating AZD1222 has begun. The trial will enroll approximately 30,000 adult volunteers at 80 sites in the USA to evaluate if this candidate vaccine can prevent symptomatic COVID-19 disease.
August 16, 2020 - Mumbai's KEM and Nair hospitals have begun testing the vaccine candidate in India.
August 14, 2020 - AstraZeneca announced an agreement with the European Commission to supply up to 400 million doses of the AZD1222 COVID-19 vaccine. This new agreement will give all EU member states the option to access the vaccine in an equitable manner at no profit during the pandemic. It also allows EU member states to redirect doses to other European countries.
August 6, 2020 - Shenzhen Kangtai Biological Products announced it will produce AstraZeneca Plc's potential COVID-19 vaccine AZD1222 in mainland China. The Shenzhen-based company must have the capacity to produce at least 200 million vaccine doses by the end of 2021, as part of the exclusive framework agreement.
August 1, 2020 - The Drugs Controller General of India has given approval to the Serum Institute of India, Pune, to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD).
July 29, 2020 - Adar Poonawalla's Serum Institute had filed an application seeking permission from Drugs Controller General of India for trials of Oxford-AstraZenca vaccine candidate, Covishield. The regulator has asked Serum Institute to demarcate Phase II and Phase III parts of the protocol and conduct Covishield trials all over India, the daily further reported.
July 27, 2020 - Emergent BioSolutions announced that it has signed an agreement to provide contract development and manufacturing services for AstraZeneca’s COVID-19 vaccine candidate, AZD1222. The agreement is valued at approximately $174 million through 2021 and follows an $87 million contract in June for development services, performance and process qualification, raw materials, and an initial capacity reservation.
July 23, 2020 - Between treating patients and researching the virus, Dr. Erdmann is also preparing to launch one of UAB’s largest clinical trials in years, testing whether a vaccine developed by Oxford University and drug manufacturer AstraZeneca will protect against COVID-19. Dr. Paul Goepfert, who is also leading the trial of AZD1222 at UAB said, “We are going to do vaccinate at least 500 individuals locally.”
July 20, 2020 - The Lancet confirmed in a preliminary report of the COV001/2 phase 1/2 study a single dose of AZD1222 resulted in a 4-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 2-months after vaccination. COV001 is a blinded, multi-center, randomized controlled Phase I/II trial with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten participants also received two doses of AZD1222 one month apart.
July 17, 2020 - Moscow unveiled an agreement with AstraZeneca for it to produce a coronavirus vaccine being developed by the firm and Oxford University. Alexey Repik, R-Pharm’s board chairman, said his company had signed the deal. Kirill Dmitriev, head of the Russian Direct Investment Fund, said 'Russia’s acquisition of the British-developed vaccine was designed to complement, not replace its own home-grown vaccine, which is the one that Moscow is focusing on.'
July 14, 2020 - IQVIA announced its collaboration with AstraZeneca to accelerate the development of a potential new vaccine for COVID-19 is also part of the U.S. government’s recently announced Operation Warp Speed project. The specific IQVIA and AstraZeneca collaboration will drive faster delivery of clinical studies in the U.S. aimed at demonstrating the efficacy of AstraZeneca’s potential COVID-19 vaccine, AZD1222.
July 1, 2020 - Speaking at a parliamentary hearing, Sarah Gilbert, professor of vaccinology at Oxford University, said 8,000 volunteers had been enrolled for the Phase III of its trial into the vaccine, AZD1222, which was licensed to AstraZeneca. “We’re very happy that we’re seeing the right sort of immune response that will give protection, and not the wrong sort,” Gilbert said.
June 30, 2020 - AstraZeneca expects the first batch of 15.2 million doses to be produced by December 2020, and another, with the remaining 15.2 million doses, to be delivered in January 2021. After this production, it would still be necessary to go through the phases of registration and validation, prior to a possible distribution.
June 28, 2020 - Brazil's Health Ministry executive secretary Elcio Franco said under the US$127 million deal, the Brazilian government’s public-health institute will acquire the technology and supplies to produce the AZD1222 SARS-CoV-2 vaccine, which is being tested in Britain and South Africa, as well as Brazil, reported SCMP. If the vaccine is demonstrated to be effective, 100 million doses will be available to the Brazilian population.
June 27, 2020 - Volunteers in Brazil have begun receiving a trial vaccine against COVID-19, in Latin America’s first phase 3 COVID-19 clinical trial. The trial officially began on Saturday 20th June and will enroll 5,000 volunteers across the country. Vaccinations will take place in Sao Paulo, Rio de Janeiro, and a site in the Northeast of Brazil.
June 23, 2020 - The first South Africa clinical trial for a vaccine against COVID-19 disease will vaccinate participants this week. Wits University is collaborating with the University of Oxford and the Oxford Jenner Institute on the South African trial.
June 20, 2020 - A new study reported 'Whilst a single dose induced antigen-specific antibody and T cells responses, a booster immunization enhanced antibody responses, particularly in pigs, with a significant increase in SARS-CoV-2 neutralizing titers.' This research was released by Britain’s Pirbright Institute suggests a 2-dose approach may be more effective in getting protection against COVID-19 disease which is caused by SARS-CoV-2.
June 13, 2020 - AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance, spearheaded by Germany, France, Italy, and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. AZ's total manufacturing capacity currently stands at 2 billion doses.
June 11, 2020 - AstraZeneca Plc announced it selected Emergent BioSolutions to help produce the 300 million doses of the COVID-19 vaccine candidate pledged to the United States. Emergent is also working to boost the manufacturing of COVID-19 vaccines under development at Johnson & Johnson, Novavax, and Vaxart. Large-scale manufacturing will be done at the Baltimore Maryland Bayview facility.
June 9, 2020 - Serum Institute of India, the world's largest vaccine manufacturer, is investing USD 100 million on a potential COVID-19 vaccine being developed at Oxford University. The Pune-based company has partnered with AstraZeneca, a British biopharma giant, to ensure equitable supply of the AZD1222 vaccine doses to India as well as low-and-middle-income countries.
June 4, 2020 - AstraZeneca reached a $750m agreement with CEPI and Gavi to support the manufacturing, procurement, and distribution of 300 million doses of the potential vaccine, with delivery starting by the end of 2020. In addition, AstraZeneca reached a licensing agreement with SII to supply 1-billion doses for low-and-middle-income countries, with a commitment to provide 400 million before the end of 2020.
June 4, 2020 - The Coalition for Epidemic Preparedness Innovations announced a partnership with AstraZeneca which will support the manufacture of 300 million doses of the AZD1222 vaccine candidate to be ringfenced for the COVID-19 Vaccine Global Access Facility. if the vaccine is proven to be safe and effective.
June 2, 2020 - The Brazilian Health Regulatory Agency (ANVISA) approved the inclusion of Brazil in the clinical trials conducted by Oxford University and supported by AstraZeneca, considering 2,000 volunteers to be tested in the country.
May 23, 2020 - “It’s a race against the virus disappearing, and against time,” Professor Adrian Hill, director of the Jenner Institute, told the Telegraph. “We said earlier in the year that there was an 80% chance of developing an effective vaccine by September. But at the moment, there’s a 50% chance that we get no result at all.”
May 22, 2020 - University of Oxford researchers announced they have begun recruiting participants for the next phase in human trials of a COVID-19 vaccine in human volunteers. The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children.
May 21, 2020 - AstraZeneca has received more than $1 billion from the U.S. Health Department’s Biomedical Advanced Research and Development Authority to develop a coronavirus vaccine from the University of Oxford called AZD1222. AstraZeneca has agreed to initially supply at least 400 million doses of the vaccine and secured total manufacturing capacity to produce 1 billion doses, with first deliveries in September.
May 21, 2020 - Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October 2020.
May 18, 2020 - The U.K. Business Secretary Alok Sharma indicated the government has an agreement with the Imperial College London and AstraZeneca to accelerate the production of the ChAdOx1 nCoV-19 vaccine candidate. The deal will see AstraZeneca manufacture up to 30 million doses by September 2020 as part of a commitment to deliver 100 million doses in total for people in Britain. Under the agreement, London pledged 65.5 million pounds in funding for the vaccine being developed at the University of Oxford and 18.5 million pounds for related work at Imperial College London.
May 16, 2020 - Canada’s Prime Minister Trudeau announced the first clinical trial of a potential COVID-19 disease prevention vaccine, called Ad5-nCoV COVID-19, which has been approved by Health Canada.
May 14, 2020 - Everything you need to know about the Oxford University vaccine.
May 13, 2020 - A non-peer-reviewed study showed that a single vaccination in rhesus macaques with ChAdOx1 nCoV-19 is effective in preventing damage to the lungs upon high dose challenge with SARS-CoV-2. Similarly, a recent study showed that a triple vaccination regime of a high-dose of whole inactivated SARS-CoV-2 protected rhesus macaques from SARS-CoV-2 pneumonia.
April 30, 2020 - AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of the recombinant adenovirus vaccine aimed at preventing COVID-19 disease from SARS-CoV-2 coronavirus infections.
April 28, 2020 - The Serum Institute of India said it plans to produce up to 60 million doses of the vaccine against the new coronavirus that is under clinical trial in Britain.
April 24, 2020 - Vaccitech announces today that its scientific founders at the Jenner Institute, University of Oxford, have begun testing a COVID-19 vaccine in human volunteers.
- April 23, 2020 - University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford today. Around 1,110 people will take part in the trial, half receiving the vaccine, and the control group receiving a widely available meningitis vaccine.
AZD1222 Vaccine Clinical Trials
AZD1222 is undergoing late-stage clinical trials in Britain, Brazil, and South Africa, with additional trials planned in Japan and Russia. These trials, together with the U.S. Phase III study, aim to enroll up to 50,000 participants globally.
Clinical Trial NCT04568031: Study of AZD1222 for the Prevention of COVID-19 in Japan
Clinical Trial NCT04540393: AZD1222 Vaccine for the Prevention of COVID-19
- The purpose of this study is to evaluate the safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation.
Clinical Trial NCT04516746: Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
- The aim of this Phase 3 study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19. Last Update Posted: August 18, 2020.
Clinical Trial NCT04324606: A Study of a Candidate COVID-19 Vaccine (COV001)
- COV001 is a phase I/2 single-blinded, randomized, placebo-controlled, multi-center study to determine efficacy, safety, and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years.