AZD1222 SARS-CoV-2 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.
The AZD1222 vaccine candidate has progressed into late-stage Phase II/III clinical trials in more than 10,000 people from across the UK.
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.
The AZD1222 vaccine was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group.
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.
AZD1222 SARS-CoV-2 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 SARS-CoV-2 Vaccine Dosage
Biological: ChAdOx1 nCoV-19 - A single dose of 5x10^10vp of ChAdOx1 nCoV-19.
Biological: ChAdOx1 nCoV-19 boost - A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10^10vp of ChAdOx1 nCoV-19.
AZD1222 SARS-CoV-2 Vaccine News
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 SARS-CoV-2 Vaccine Clinical Trials
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 vaccine to prevent COVID-19 on 20th January 2020, and is led by Prof. Sarah Gilbert, Prof. Andrew Pollard, Prof. Teresa Lambe, Dr. Sandy Douglas, Prof. Catherine Green, and Prof. Adrian Hill.
Clinical Trial NCT04324606: A phase I 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.
- Primary outcomes: Assess the efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases
- Up to 1,102 healthy volunteers aged between 18-55 are being recruited for the trials in study sites across Oxford, Southampton, London, and Bristol.
- There will be 4 study groups and it is anticipated that a total of 1112 volunteers will be enrolled. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit on Day 364.
A Phase I/II clinical trial of AZD1222 to assess safety, immunogenicity, and efficacy in over 1,000 healthy volunteers aged 18 to 55 years across several trial centers in southern England. Data from the trial is expected shortly which, if positive, would lead to late-stage trials in a number of countries.
The phase III study involves assessing how the vaccine works in a large number of people over the age of 18. This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19. Adult participants in both the Phase II and Phase III groups will be randomized to receive one or 2-doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison. The Brazilian Health Regulatory Agency approved the inclusion of Brazil in the clinical trials on 2nd June, which are being conducted in partnership with AstraZeneca.