OXFORD, UK, 23 Nov 2020 (GLOBE NEWSWIRE) – Vaccitech Scientific Founders at Oxford University Announce Positive Results High-level view of an analysis of AZD1222 clinical trials in the UK and Brazil.
- Phase 3 interim analysis including 131 Covid-19 cases indicates that the vaccine is 70.4% effective when data from two dosing regimens are combined
- At the two different dose regimens, vaccine efficacy was 90% in one and 62% in the other
- The most effective regimen used a first dose reduced by half and a second standard dose
- Early indication of that the vaccine could reduce the transmission of the virus from an observed reduction in asymptomatic infections
- There were no serious or hospitalized cases in any person who received the vaccine
- Large safety database of more than 24,000 volunteers from clinical trials in the UK, Brazil and South Africa, with follow-up since April
- Fundamentally, the vaccine can be easily administered in existing healthcare systems, stored at 'temperature d the refrigerator '(2-8 ° C) and distribute using existing logistics
- Ongoing large-scale manufacturing in more than 10 countries to support equitable global access
The vaccine , ChAdOx1 nCoV-19, also known as AZD1222, was co-invented by Vaccitech and the Jenner Institute at the University of Oxford.
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said:
"These findings show that we have an effective vaccine that will save many lives. It is exciting that 'We have discovered that one of our dosing regimens can be around 90% effective, and if this dosing regimen is used, more people could be vaccinated with the planned vaccine supply. Today's announcement is only possible because of the many volunteers from our trial and hard work and a talented team of researchers from around the world. "
Professor Sarah Gilbert, a professor of vaccination at Oxford University, said:
"Today's announcement brings us one step closer to when we can use vaccines to end the devastation caused by SARS-CoV -2. We will continue to work to provide detailed information to regulators. It has been a privilege to be part of this multinational effort that will reap benefits for everyone. "
The University of Oxford, in collaboration with AstraZeneca plc, today announces interim data from its phase III trials showing its candidate vaccine, ChAdOx1 nCoV-2019, is effective in preventing COVID-19 (SARS-CoV-2) and offers a high level of protection.
Bill Enright, Executive Director of Vaccitech, commented:
"The world needs a cost-effective and easy-to-distribute COVID-19 vaccine that is safe and works to control the continued spread of this devastating pandemic. Vaccitech is proud to have been a small part of the team, along with the University of Oxford and AstraZeneca, that brought this vaccine from concept to reality in record time. These latest data give us greater confidence in the potential of our ChAdOx technology platform to address other major unmet needs in infectious diseases and cancer. "
After the trial reached the goal of interim analysis, the independent Data and Safety Monitoring Board (DSMB) recommended that the team Oxford University will conduct its first analysis of all cases with blocked data on November 4, 2020.
These preliminary data indicate that the vaccine is 70.4% effective, with tests in two different dose regimens showing that the vaccine was 90% effective if given at half dose and then at full dose, or 62% if given in two full doses.
Additional cases are expected to accumulate by the time of the final analysis and future analyzes will determine the duration of protection. No serious vaccine-related safety events have been identified.
Oxford will now support AstraZeneca in submitting interim Phase III efficacy data and extensive safety data to all regulators around the world, including in the UK, Europe, and Brazil for independent product scrutiny and approval, including for emergency use. Many of these regulators have been reviewing the assay data continuously during the trial.
In parallel, Oxford presents the full analysis of the interim Phase III data for independent scientific review and publication. Coordination of the program and the implementation of the trials in the UK would not have been possible without the support of the National Institute for Health Research and UKRI.
These data also suggest that this half-dose and full-dose regimen could help prevent transmission of the virus, evidenced by lower rates of asymptomatic infection in vaccinates, with more information available when the trial data is evaluated. ]
Phase III interim data are based on the results of peer-reviewed phase I / II Oxford trials which have shown that the vaccine induces strong antibody and T cell immune responses in all age groups, including older adults, and has a good safety profile.
The clinical trials, which enrolled more than 24,000 participants from various racial and geographic groups in the UK, Brazil and South Africa, will now continue until final analysis. More trials are underway in the United States, Kenya, Japan and India, and the trial team expects to have fewer than 60,000 participants by the end of the year. These trials will provide regulators with more information on the efficacy and safety of the Oxford candidate vaccine, including its ability to protect and arrest COVID-19 transmission.
The Oxford vaccine (ChAdOx1 nCoV-19) is made from a virus, which is a weakened version of a common cold virus (adenovirus), that has been genetically modified to make it impossible for it to grow in humans.
Adenovirus vaccines have been widely researched and used for decades and have the significant benefit that they are stable, easy to manufacture, transport, and store at home refrigerator temperatures (2-8 degrees C). This means that they can be easily distributed using existing medical facilities, such as local doctor's offices and pharmacies, allowing the vaccine, if approved, to be deployed very quickly.
The University of Oxford's collaboration with AstraZeneca has been crucial to the successful development of the vaccine and vital to its global manufacture and distribution throughout the world. AstraZeneca already has international agreements to supply three billion doses of the vaccine, and access is being built through more than 30 supply agreements and partner networks.
A key element of Oxford's partnership with AstraZeneca is a joint commitment to provide the vaccine on a non-profit basis for the duration of the pandemic worldwide and in perpetuity to low- and middle-income countries.
Professor Louise Richardson, Vice Chancellor of the University of Oxford, said:
"This is a great day for the University of Oxford and for universities around the world. Pushing the frontiers of knowledge with partners from around the world world world and putting our extraordinary intellectual capacity at the service of society, is what we do best. "
Pascal Soriot, CEO of AstraZeneca, said:
" Today marks an important milestone in our fight against the pandemic. The efficacy and safety of this vaccine confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. In addition, the simple supply chain of the The vaccine and our nonprofit's promise and commitment to broad, equitable, and timely access means that it will be affordable and available worldwide, supplying hundreds of millions of doses upon approval. "
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About Vaccitech Ltd.
Vaccitech is a clinical stage T-cell vaccine and immunotherapy company that develops products to treat infectious diseases and cancer. The company's proprietary platform, comprising chimpanzee adenovirus (prime) and MVA (boost), induces, potentiates and maintains CD8 + and CD4 + T cells, as well as antibodies. Vaccitech's Prime-Boost platform is licensed by one of the world's most prestigious vaccine research institutes, the Jenner Institute at the University of Oxford. In partnership with Jenner, Vaccitech co-invented and led aspects of the early development of a vaccine against SARS-CoV-2 (COVID-19), based on its proprietary Chimpanzee Adenovirus Oxford platform, or ChAdOx. The COVID-19 vaccine, now known as AZD1222, has been licensed to AstraZeneca and is currently in phase 3 clinical trials.
Vaccitech has multiple therapeutic programs at the clinic, including a phase 1/2 program for chronic HBV and HPV, a phase 2 program for prostate cancer, as well as a clinic-ready program for NSCLC. The company is also jointly developing prophylactic products for the MERS coronavirus and herpes Zoster with international partners. Vaccitech is supported by leading institutions such as GV, Sequoia Capital China, Korea Investment Partners, and Oxford Sciences Innovation.
Henry Hodge, Vaccitech
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