AstraZeneca COVID-19 Vaccine (AZD1222) Description
The AstraZeneca COVID-19 (AZD1222) coronavirus vaccine candidate, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus (adenovirus). 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 enter 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 people with AZD1222, researchers hope to make the body recognize and develop an immune response to the Spike protein to help stop the SARS-CoV-2 virus from entering human cells and preventing infection.
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.
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, South Africa, and trials are planned to start in Japan and Russia. Together with the US Phase III clinical trial, these trials will enroll up to 60,000 globally. If the vaccine is proven 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 November 18, 2020, The Lancet published a study review that describes this vaccine's safety and immunogenicity in a wider range of participants, including adults aged 70 years and older. The vaccine candidate, ChAdOx1 nCoV-19, appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a booster dose.
Pascal Soriot, Chief Executive Officer, said in a press statement on November 23, 2020, announcing one vaccine dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Another dosing regimen showed 62% efficacy when given as (2) full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%.
“Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and immediately impact this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable, and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval," added Soriot.
On November 27, 2020, in a letter sent by the Department of Health and Social Care to the Medicines and Healthcare products Regulatory Agency (MHRA), the UK government had asked the regulator to assess the vaccine for authorization under Regulation 174 of the Human Medicines Regulations, which enables the temporary supply of medicines to be authorized in response to a public health need. The MHRA has already started a rolling review to determine whether the Oxford/AstraZeneca vaccine meets its strict safety, efficacy, and quality standards.
The Lancet issued a press release on December 8, 2020, announcing 'the first full results from interim analysis confirm that the Oxford COVID-19 vaccine (AZD1222) has an acceptable safety profile and is efficacious against symptomatic COVID-19 disease, with no hospitalizations or severe disease reported in the COVID-19 vaccine group so far.'
'When breaking this down based on vaccine dose, those who received two standard doses of the vaccine saw a vaccine efficacy of 62% (based on 27/4,440 (0.6%) cases in the vaccine group, and 71/4,455 (1.6%) cases in the control group), and the low-dose/standard-dose group vaccine efficacy was 90% (based on 3/1,367 (0.2%) cases in the vaccine group, and 30/1,374 (2.2%) cases in the control group).'
Study author, Dr. Merryn Voysey, University of Oxford, UK, added: "The results presented in this report provide the key findings from our first interim analysis. In future analyses, with more data included as it becomes available, we will investigate differences in key subgroups such as older adults, various ethnicities, doses, timing of booster vaccines, and we will determine which immune responses equate to protection from infection or disease."
On December 17, 2020, Professor Katie Ewer, a lead author of a new paper, said: ‘This highly detailed analysis of the immune responses to ChAdOx1 nCoV-19 further underpins the potential of this vaccine to induce protection against COVID-19 disease and provides additional reassurance of the safety of this approach. Using these advanced immunological techniques, we can better understand the different cellular and antibody-mediated mechanisms that contribute to the protection afforded by this vaccine, as demonstrated in the recent data from the subsequent Phase 3 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 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. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.
On December 30, 2020, the UK's Medicines and Healthcare products Regulatory Agency provided authorization for an emergency supply of COVID-19 Vaccine AstraZeneca for the active immunization of individuals 18 years or older. On January 6, 2021, the Serum Institute of India obtained emergency use authorization in India for AstraZeneca’s COVID-19 vaccine. AstraZeneca’s COVID-19 vaccine has been granted emergency authorization in Argentina, Dominican Republic, El Salvador, Mexico, and Morocco. And on January 12, 2021, the EMA received an application for conditional marketing authorization of COVID-19 Vaccine AstraZeneca.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines, primarily for treating diseases in three therapy areas - Onc Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries.
AstraZeneca COVID-19 Vaccine (AZD1222) Distribution
AstraZeneca continues to engage with governments, multilateral organizations, and collaborators worldwide to ensure broad and equitable access to the vaccine at no profit for the pandemic duration. The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.
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 agreed on a license with India's Serum Institute for the supply of an additional one billion doses, principally for low-and-middle-income countries.
On December 8, 2020, HALIX B.V. announced it would provide commercial manufacturing of drug substance at its state-of-the-art cGMP facility at the Leiden Bio Science Park in the Netherlands. HALIX expands with 2 additional viral vector production lines to meet the increased demand.
Malaysia's government signed an agreement to procure 6.4 million doses of its COVID-19 vaccine for about 10 percent of its population.
India granted emergency approval for the coronavirus vaccine co-developed by AstraZeneca Plc and the University of Oxford on January 1, 2021. Covishield is the Serum Institute of India (SII) version of the AstraZeneca COVID-19 vaccine. SII is reported to have stockpiled 75 million doses of the CoviShield vaccine. SII's fact sheet for CoviShield.
On January 19, 2021, the Government of India announced it grant assistance to Bhutan, Maldives, Bangladesh, Nepal, Myanmar, and Seychelles by distributing CoviShield vaccines beginning January 20, 2021. In Sri Lanka, Afghanistan, and Mauritius, India is awaiting regulatory clearances.
AstraZeneca COVID-19 (AZD1222) Indication
The AZD1222 (ChAdOx1 nCoV-19) vaccine candidate is being tested in clinical trials to prevent infection of SARS-CoV-2, which causes COVID-19 disease. The global trials evaluate participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
Pediatric and pregnancy vaccination efficacy verification pending.
AstraZeneca COVID-19 (AZD1222) Dosing
AstraZeneca announced on November 23, 2020, the 1-dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001).
Participants in the Phase 3 COVID-19 vaccine study group received 2-doses, each containing 5x1010 viral particles (a standard dose). However, a subset (1,367 people) in the UK received a half dose as their first dose, followed by a full second dose. This was because of differences in quantification methods between batches of the vaccine. The low-dose/standard-dose group did not include adults over the age of 55; the low-dose was given in an early stage of the trial before the recruitment of older adults had commenced.
A study published on December 17, 2020, reported the booster doses of the vaccine are both shown to induce stronger antibody responses than a single dose, with the standard dose / standard dose inducing the best response – supporting the decision taking previously to move to a 2-dose vaccine regimen in the Phase III clinical trials.
AstraZeneca COVID-19 Vaccine (AZD1222) Side Effects
Pending official data.
Vaccines made from the ChAdOx1 virus have been found safe and well-tolerated, although they can cause temporary side effects, such as a change in temperature, headache, or a sore arm.
Local media in India, Anadolu Agency, reported on January 17, 2021, “Of the 447 Adverse Event Following Immunization (AEFIs), three had to be hospitalized, while two of them have now been discharged after 24 hours, one continues to be under observation,” said Manohar Agnani, joint secretary at the Health Ministry.
AstraZeneca COVID-19 Vaccine (AZD1222) Storage Requirements
The vaccine can be stored, transported, and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least 6-months and administered within existing healthcare settings.
AstraZeneca COVID-19 Vaccine (AZD1222) News
January 16, 2021 - Gulf News confirmed the AstraZeneca’s COVID-19 vaccine had been approved for emergency use in Pakistan, making this experimental coronavirus vaccine the first authorization. Pakistan has announced to provide coronavirus vaccines free of charge to its citizens. Pakistan’s frontline healthcare workers would be at the top of the vaccine priority list. Initially, the vaccine would be administered to healthcare workers and people over 65.
January 12, 2021 - The European Medicines Agency (EMA) has received an application for conditional marketing authorization for a COVID-19 vaccine developed by AstraZeneca and Oxford University. An opinion on the marketing authorization could be issued by January 29, 2021, during the meeting of EMA’s scientific committee for human medicines.
January 7, 2021 - The AP reports South Africa says it will import 1.5 million doses of the AstraZeneca vaccine to inoculate its health workers. This is South Africa’s first announcement of a COVID-19 vaccine purchase. The first 1 million doses will be delivered later this month from the Serum Institute of India, followed by an additional 500,000 doses in February, Health Minister Zwelini Mkhize announced.
January 6, 2021 - AstraZeneca’s COVID-19 vaccine has been granted emergency use authorization in India and Argentina, the Dominican Republic, El Salvador, Mexico, and Morocco for adults' active immunization. India's approval is an important milestone as it will enable us to supply India and many countries worldwide. AstraZeneca has partnered with Serum Institute of India, the world's largest vaccine manufacturer, to supply the Indian Government and many low and middle-income countries.
January 5, 2021 - Medicines and Healthcare products Regulatory Agency - Public Assessment Report Authorisation for Temporary Supply COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine (ChAdOx1-S [recombinant]) Department of Health and Social Care.
January 2, 2021 - Brazil's Anvisa announced that it had approved a request for the exceptional import of vaccines by Fiocruz. On December 31, 2020, the approval took place the same day that Fiocruz filed the import order. The import includes two million doses of the Oxford vaccine, AZD1222. As this is a vaccine import that has not yet been approved in the country, entry into the country must follow certain conditions established by Anvisa.
January 1, 2021 - India's Minister Prakash Javdekar said the AstraZeneca vaccine produced locally by the Serum Institute of India Ltd., CoviShield, was granted emergency approval. CoviShield has been identified as a more suitable vaccine for reaching people in India's remotes areas.
December 30, 2020 - AstraZeneca announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) had provided authorization for an emergency supply of COVID-19 Vaccine AstraZeneca, formerly AZD1222, for the active immunization of individuals 18 years or older. The authorization recommends two doses administered with an interval of between four and 12 weeks. This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalizations more than 14 days after the second dose.
December 30, 2020 - Health Canada announced it is aware that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca. Health Canada has been reviewing AstraZeneca's vaccine since it was submitted on October 1, 2020, and is expediting the review of COVID-19 vaccines.
December 30, 2020 - Dr. Jeremy Farrar, Director of Wellcome, said: “Now begins the enormous task of scaling up vaccination to as many people as possible. It is much better to vaccinate as many people as possible with one dose than half that number of people with two doses in the next few months. It remains critical that groups most at risk, such as the elderly and frontline healthcare and essential workers, prioritize receiving the first doses. Still, we must not delay getting the vaccine to everyone in this country and worldwide. The dosing regimen announced today will allow a more rapid rollout.
December 27, 2020 - AstraZeneca's CEO Pascal Soriot said theCOVID-19 vaccine candidate AZD1222 had achieved a “winning formula” efficacy. Soriot stated the University of Oxford developed a vaccine that can provide ‘100 protection’ against severe COVID-19 after initially showing an average of 70% effectiveness.
December 21, 2020 - Russian Direct Investment Fund, N.N. N.F. Gamaleas, AstraZeneca, and R-Pharm signed an agreement on developing and implementing a clinical research program to assess the immunogenicity and safety of the combined use of one of the components Sputnik V vaccine of the Center. Hamalea and one of the components of the AZD1222 vaccine, developed by AstraZeneca in conjunction with the University of Oxford.
December 17, 2020 - Researchers from the University of Oxford have published further data from the Phase I/II clinical trials of the ChAdOx1 nCoV-19 coronavirus vaccine, evidencing the decision to move to a 2-dose regimen in ongoing phase III trials and how ChAdOx1 nCov-19 is inducing broad antibody and T cell functions.
December 8, 2020 - Study published by The Lancet: Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomized controlled trials in Brazil, South Africa, and the UK. 'Interim results of the Oxford COVID-19 vaccine trials find that the vaccine protects against symptomatic disease in 70% of cases - with vaccine efficacy of 62% for those given two full doses, and of 90% in those given a half than a full dose (both trial arms pre-specified in the pooled analysis). The results are the first full peer-reviewed efficacy results to be published for a COVID-19 vaccine and are published in The Lancet. The vaccine was found to be safe, with only three out of 23,745 participants over a median of 3.4 months experiencing serious adverse events that were possibly related to a vaccine; one in the vaccine arm, one in the control arm, and one in a participant who remains masked to group allocation. All participants have recovered or are recovering and remain in the trial.
December 8, 2020 - Netherlands based HALIX B.V. announced signed an agreement with AstraZeneca AB for large-scale commercial drug substance manufacture of AZD1222, the adenovirus vector-based COVID-19 vaccine.
November 27, 2020 - The UK government has formally asked the Medicines and Healthcare products Regulatory Agency to evaluate whether the Oxford/AstraZeneca vaccine supply can be authorized. The UK will be one of the first countries in the world to receive the vaccine, if authorized, with AstraZeneca expecting to have up to 4 million doses ready for the UK by the end of the year and 40 million by the end of March 2021.
November 24, 2020 – Gavi, the Vaccine Alliance, issued a statement 'welcoming the release of interim efficacy data for the AstraZeneca/Oxford COVID-19 vaccine candidate.' Dr. Seth Berkley, CEO of Gavi, added, “Positive early data on any vaccine candidate is welcome news – even more so when it concerns a vaccine candidate that can be transported and delivered via traditional refrigeration and storage methods, and the manufacturer has committed to supply on a not-for-profit basis for the duration of the pandemic. As a vaccine candidate that can utilize standard 2-8 degree cold chain infrastructure for transport, storage, and delivery, the implications of this announcement for access to all countries – particularly lower-income ones – are significant.'
November 23, 2020 - AstraZeneca issues a press statement saying 'Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis. More data will continue to accumulate, and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.
November 21, 2020 - The Lancet published: Notice of addendum to Article reporting Oxford trial of ChAdOx1 nCoV-19 vaccine.
November 18, 2020 - A study published by The Lancet found ChAdOx1 nCoV-19 appears to be well tolerated in older adults and has similar immunogenicity across all age groups after a booster dose. Further assessment of this vaccine's efficacy is warranted in all age groups and individuals with comorbidities.
November 8, 2020 - Melbourne-based CSL Limited confirmed it would commence manufacturing the University of Oxford - AstraZeneca AZD1222 COVID-19 vaccine candidate at its advanced manufacturing facility in Broadmeadows, Victoria, on November 9, 2020. CSL has separate contracts with AstraZeneca and the Australian Government to manufacture approximately 30 million doses of the AZD1222 vaccine candidate, with the first doses planned for release in the first half of 2021, pending the outcome of clinical trials and regulatory approval. The TGA in Australia has granted the AZD1222 vaccine a provisional determination. AstraZeneca said it would manage the application for registration for the vaccine on the Australian Register of Therapeutic Goods.
November 7, 2020 - Article published by The Lancet: 'As a participant in the ChAdOx1 nCoV-19 vaccine trial, I was particularly excited to read the preliminary report by Pedro Folegatti and colleagues and congratulate the team on their promising results. However, glancing at the summary of adverse reactions in figure 1 of the Article, I was uncomfortably surprised to discover that I had unmasked myself. I self-reported moderate feverishness, which was experienced by 21% (12 of 56) of the ChAdOx1 nCoV-19 paracetamol group and none of the associated control group.
November 4, 2020 - The UK Vaccine Taskforce Chair Kate Bingham said that the target of 30 million doses of the vaccine by September had not been achieved. She estimated that Britain would get 4 million doses by the end of 2020.
November 1, 2020 - “We confirm the UK's Medicines and Healthcare Products Regulatory Agency rolling review of our potential COVID-19 vaccine,” an AstraZeneca spokesman said, according to Reuters. In rolling reviews, regulators can see clinical data in real-time and have a dialogue with drug makers to accelerate the approval process.
October 30, 2020 - Kenya announced it had joined the global efforts in search of an effective vaccine for COVID-19 with the start of a trial evaluating the ChAdOx1 nCoV-2019 Oxford coronavirus vaccine. The trial in Kenya will initially involve 40 frontline workers in Kilifi County. Once the vaccine safety is confirmed, a further 360 volunteers will be recruited with possible expansion of the trial to Mombasa County.
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 phase 3 clinical trial. The FDA reviewed all safety data from trials globally and concluded it was safe to resume it. 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 examine safety data by independent monitoring committees. The recommendations from these reviews have been supported by international regulators, who 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. To commence the Thai population's vaccination in the first half of 2021.
October 16, 2020 - The Swiss federal government signed an agreement with AstraZeneca to deliver up to 5.3 million doses of the ChAdOx1 nCoV-19 vaccine, provided it successfully passes the clinical trial phase and is approved by Swissmedic.
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, aiming 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. As the trial sponsor, AstraZeneca and the University of Oxford cannot disclose further medical information. According to the clinical trial and regulatory standards, all trial investigators and participants will be updated with the relevant information, and this will be disclosed on global clinical registries.
September 12, 2020 - Serum Institute of India announced phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate would 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. At the same time, it is investigated, ensuring we maintain the trials' integrity.
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 had 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 India's vaccine candidate.
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 equitably 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 would 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 approved 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 the 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 had 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 SARS-CoV-2 virus spike protein in 95% of participants one month after injection. A T-cell response was induced in all participants, 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. 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 to produce a coronavirus vaccine 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. to demonstrate 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 was licensed to AstraZeneca. “We’re pleased that we see 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 registration and validation phases before 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 occur in Sao Paulo, Rio de Janeiro, and 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. SARS-CoV-2 neutralizing titers.' Britain’s Pirbright Institute released this research 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 in a potential COVID-19 vaccine developed at Oxford University. The Pune-based company has partnered with AstraZeneca, a British biopharma giant, to ensure an equitable supply of the AZD1222 vaccine doses to India and 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. Also, 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 ringfenced for the COVID-19 Vaccine Global Access Facility. Suppose the vaccine is proven to be safe and effective.
June 2, 2020 - The Brazilian Health Regulatory Agency (ANVISA) approved Brazil's inclusion 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 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 develops 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 Accelerated 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, 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 effectively prevents damage to the lungs upon high dose challenge with SARS-CoV-2. Similarly, a recent study showed 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 to prevent 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 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 participate in the trial, half receiving the vaccine, and the control group receiving a widely available meningitis vaccine.
AstraZeneca COVID-19 Vaccine (AZD1222) Clinical Trials
AZD1222 is undergoing late-stage clinical trials in Japan, Russia, South Africa, Kenya, and Latin America, with planned trials in other European and Asian countries. Together with the U.S. Phase III study, these trials aim to enroll up to 60,000 globally.
Clinical Trial NCT04568031: Study of AZD1222 for the Prevention of COVID-19 in Japan - Last Update Posted: November 13, 2020.
A Phase I/II Randomized, Double-blind, Placebo-controlled Multicentre Study in Participants Aged 18 Years or Older to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19
Clinical Trial NCT04540393: AZD1222 Vaccine for the Prevention of COVID-19
This study evaluates 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. Last Update Posted: December 2, 2020.
This Phase 3 study aims to assess the safety, efficacy, and immunogenicity of AZD1222 to prevent COVID-19. Approximately 40,051 participants as of November 19, 2020. Last Update Posted: December 2, 2020.
The interim analysis published on December 8, 2020, pools the data from these for analysis, providing greater precision for efficacy and safety outcomes than possible in individual trials and giving a broader understanding of the use of the vaccine in different populations.
Safety was monitored for a median of 3.4 months in all 23,745 participants from the UK, Brazil, and South Africa. Out of 23,745 participants, 168 experienced a total of 175 severe adverse events over the period, but 172 events were unrelated to the COVID-19 or control vaccines.
The primary outcome of the study was to determine how many cases of symptomatic COVID-19 disease (confirmed by positive test, and the participant has a fever, cough, shortness of breath, or loss of smell or taste) there were in participants who had received two doses of the vaccine (with the first dose being either low or standard dose, and the second dose being standard dose), compared with controls.
There were 69 cases of asymptomatic COVID-19 disease identified in the UK study's weekly COVID-19 testing of 6,638 people. This included 29/3,288 (0.9%) cases in the vaccine group, and 40/3,350 (1.2%) cases in the control group, leading to a vaccine efficacy against asymptomatic transmission of 27%.
In the low-dose/standard-dose group, there were 7/1,120 (0.6%) cases in the vaccine group and 17/1,127 (1.5%) cases in the control group, resulting in vaccine efficacy against asymptomatic transmission of 59%. In people given two standard doses, there were 22/2,168 (1%) cases in the vaccine group and 23/2,223 (1%) in the control group, which equates to a vaccine efficacy against asymptomatic transmission of 4%.
Cases of severe disease and hospitalization were monitored for in all 23,745 participants. From 21 days after the first dose, there were 10 cases hospitalized for COVID-19, all in the control arm, and two were classified as severe, including one death. These are also secondary outcomes and will require additional confirmation.
The authors note that they are not yet able to assess the duration of protection, as the first trials were initiated in April 2020, and all disease episodes have accrued within six months of the first dose is administered. Further evidence will be required to determine the duration of protection and the need for additional booster doses of vaccine.
Estimated Primary Completion Date: March 23, 2021.
Clinical Trial NCT04324606: A Study of a Candidate COVID-19 Vaccine (COV001). Last Update Posted: November 18, 2020.
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.
Estimated Primary Completion Date: October 2021.