Oxford University welcomes UK regulatory emergency use authorisation of coronavirus vaccine

30 December 2020

The University of Oxford welcomes the news that the UK Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise the emergency use of the ChAdOx1 nCoV-19 coronavirus vaccine in the UK.

The Joint Committee on Vaccination and Immunisation (JCVI) will also publish its latest advice for the priority groups to receive this vaccine, with this announcement indicating that the JCVI has advised the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.

The second dose completes the course and is important for longer term protection, and everyone will still receive their second dose within 12 weeks of their first, an approach the JCVI believes will maximise the maximise the benefits of this vaccine, ensuring at-risk people are able to get meaningful protection and ease the pressure on the UK National Health Service.

Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said:
‘The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants.’
‘Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.’

Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, said:
‘This is a day for the team developing the vaccine to celebrate, after a year of extremely hard work under difficult circumstances. Now that the first authorisation or use of the vaccine outside of clinical trials has been granted, we still have more to do and will continue to provide more data to multiple regulatory authorities, until we are able to see the vaccine being used to save lives around the world.’

Professor Adrian Hill, Director of the Jenner Institute said:
‘For the past 25 years, staff at the Jenner Institute have worked to develop vaccines using novel technologies to protect people around the world from diseases that claim many lives each year. The work on ChAdOx1 nCoV-19 builds on many years of research by a dedicated team of vaccinologists, and we are delighted to see the first emergency use licensure.’

The Oxford vaccine (ChAdOx1 nCoV-19) is made from a weakened version of a common cold virus (adenovirus), that has been genetically changed so that it is safe and impossible for it to grow in humans. It is stable, easily manufactured, transported and stored at domestic fridge temperature (2-8 degrees C), so can be easily administered in existing healthcare settings, allowing for the vaccine to be deployed very rapidly.

Oxford University’s collaboration with AstraZeneca has been crucial to the successful development of the vaccine and vital for its global manufacturing and distribution across the world. AstraZeneca already has international agreements in place to supply three billion doses of the vaccine, with access being built through more than 30 supply agreements and partner networks.

A key element of Oxford’s partnership with AstraZeneca is the joint commitment to provide the vaccine on a not-for-profit basis for the duration of the pandemic across the world, and in perpetuity to low- and middle-income countries.

Professor Louise Richardson, Vice-Chancellor at the University of Oxford, said:
‘This is a great day for British science and a great day for universities everywhere. Above all, it is a great day for the many people whose lives will be saved by this vaccine. We are greatly indebted to those who have designed, developed, manufactured and evaluated ChAdOx1.’

Pascal Soriot, Chief Executive Officer, said:
‘Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.’

Notes to editors

For further information or to arrange an interview, please contact the University of Oxford press office at [email protected] or on +44 (0)1865 280528.

For more about the Oxford vaccine project and team: www.ox.ac.uk/covid-vaccine

MHRA website: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

Here is the DH statement: https://www.gov.uk/government/news/oxford-universityastrazeneca-vaccine-authorised-by-uk-medicines-regulator

Previous papers published on this project:

Phase 1/2 trial of SARS-CoV-2 vaccine ChAdOx1 nCoV-19 with a booster dose induces multifunctional antibody responses. Barrett, J.R., Belij-Rammerstorfer, S., Dold, C. et al. Nat Med (2020).
T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Ewer, K.J., Barrett, J.R., Belij-Rammerstorfer, S. et al. Nat Med (2020).
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. M Voysey, S A Costa Clemens, S A Madhi, L Y Weckx, P M Folegatti, P K Aley, et al. The Lancet (2020).
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. M N Ramasamy, A M Minassian, K J Ewer, A L Flaxman, P M Folegatti, D R Owens, et al. The Lancet (2020).
Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. P Folegatti, K Ewer, C Green, A Douglas, A Hill, T Lambe, S Gilbert, A Pollard et al. The Lancet (2020).
Evaluation of the immunogenicity of prime-boost vaccination with the replication-deficient viral vectored COVID-19 vaccine candidate ChAdOx1 nCoV-19. Graham, Lambe et al. NPJ Vaccines (2020).
ChAdOx1 nCoV-19 vaccine prevents SARS-CoV-2 pneumonia in rhesus macaques. van Doremalen, Lambe et al. Nature (2020).

For detailed information about the vaccine trial: covid19vaccinetrial.co.uk

Images:

Credit: University of Oxford, John Cairns
Oxford Vaccine Vial:

https://www.dropbox.com/sh/uj7itywvcdvoudt/AADjI_sgCzcVzPpdvbUqrqcea?dl=0

Video:

Downloadable researcher interviews and b-roll for video editors and broadcast:

https://vimeo.com/showcase/7803812 Please contact the News Office for a password

NOTE: These are for downloading and editing by media outlets, not for uploading or using wholesale.
Short explainer video for social media or embed:

https://youtu.be/xHJ_RqeXXy0

Acknowledgements:
This trial is funded by the National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites.

About the Oxford COVID-19 vaccine
The vaccine has been shown to be safe and effective by the regulator with full data already published in peer reviewed scientific journals

There have been no hospitalised or severe cases in anyone who received the vaccine
Large safety database from over 24,000 volunteers from clinical trials in the UK, Brazil and South Africa, with follow up since April
Crucially, vaccine can be easily administered in existing healthcare systems, stored at ‘fridge temperature’ (2-8 °C) and distributed using existing logistics
Large scale manufacturing ongoing in over 10 countries to support equitable global access

ChAdOx1 nCoV-19, now known as AZD1222 co-invented by the University of Oxford and its spin-out company, Vaccitech, is being trialled by the University’s Jenner Institute and Oxford Vaccine Group. The team started working to develop a vaccine against coronavirus in January 2020.

Developed at the Jenner Institute, the recombinant adenovirus vector ChAdOx1 nCoV-19 uses a viral vector based on a weakened version of the common cold virus (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body.

Around 24,000 people have volunteered for trials led by the Oxford Vaccine Group at the University of Oxford of ChAdOx1 nCoV-19 coronavirus vaccine, with data gathered from these volunteers to date showing the vaccine to be safe and well tolerated, although it can cause temporary side effects, such as a temperature, flu-like symptoms, headache or sore arm.

The potential vaccine entered Phase III clinical trials in May to study safety and efficacy in healthy volunteers across 19 trial sites in the UK. The University of Oxford is also working with research partners at a number of clinical trial sites around the world as part of this late stage trial.

COV001
COV001 is a blinded, multi-centre, randomised, controlled Phase I/II trial assessing safety, immunogenicity and efficacy of ChAdOx1 nCoV-19 in 1,077 healthy adults in five trial centres in the UK. Participants aged 18-55 years are randomised to receive one or two intramuscular doses of ChAdOx1 nCoV-19 at 5x1010 viral particles or comparator, meningococcal vaccine MenACWY. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Weekly COVID-19 PCR testing is performed with retest at 3-5 days post-symptoms onset if the first sample is negative and 7 days after a positive PCR test.

COV002
COV002 is a single-blinded, multi-centre, randomised, controlled Phase II/III trial assessing the safety, efficacy and immunogenicity of ChAdOx1 nCoV-19 in 12,390 participants in the UK. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants receive one or two intramuscular doses of a half dose (~2.5 x1010 viral particles) or full dose (~5x1010 viral particles) of ChAdOx1 nCoV-19 or comparator, meningococcal vaccine MenACWY. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR. In addition, weekly swabbing is done for detection of infection and assessment of vaccine efficacy against infection.

COV003
COV003 is a single-blinded, multi-centre, randomised, controlled Phase III trial assessing the safety, efficacy, and immunogenicity of ChAdOx1 nCoV-19 in 10,300 participants in Brazil. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants are randomised to receive two intramuscular doses of a full dose (~5x1010 viral particles) of ChAdOx1 nCoV-19 or comparator, meningococcal vaccine MenACWY as first dose and a saline placebo as second dose. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR.

COV005
COV005 is a blinded, multi-centre, randomised, controlled Phase I/II trial assessing the safety, efficacy, and immunogenicity of ChAdOx1 nCoV-19 in 2,070 participants in South Africa. Trial participants are aged 18-65 years, who are living with or without HIV, are randomised to receive two intramuscular doses of ChAdOx1 nCoV-19 at 5-x1010 viral particles or saline placebo. Participants had blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Regular COVID-19 PCR testing is performed up to one year post-vaccination.

Not for profit information:
As part of our agreement with our partner AstraZeneca, the vaccine will be supplied on a not-for-profit basis for the duration of the pandemic and in perpetuity for low- and middle-income countries.

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