World Health Organization experts provide guidance on use of the Oxford vaccine
10 February 2021
WHO SAGE advises use of ChAdOx1- nCov19 to prevent coronavirus disease in adults from 18 years of age.
- Advises 2 doses at 8-12 weeks interval based on immunogenicity increase with a longer interdose interval
- Vaccine shown to be highly effective and safe, preventing hospitalisation from COVID-19
- WHO SAGE says it is safe and likely to be efficacious in older adults and recommends its use in this age group
The World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) yesterday produced guidelines for the emergency use of the ChAdOx1 nCoV-19 coronavirus vaccine developed by the University of Oxford with its partner AstraZeneca.
The WHO has recommended that two standard doses of ChAdOx1 nCoV-19 be administered at an 8- to 12-week interval in people aged 18 years and older. This dosing regimen was shown in clinical trials to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations from COVID-19 more than 14 days after the second dose.
The new guidance marks a key step towards the University and AstraZeneca’s goal of providing global access to the vaccine, which is being made available on a not-for-profit basis during the pandemic. The vaccine is 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 rapidly around the world.
Andrew Pollard, Professor of Paediatric Infection and Immunity, and Chief Investigator on the Oxford vaccine trial, said:
‘The new guidance from WHO is an important milestone in extending access to the Oxford-AZ vaccine to all corners of the world and providing further endorsement that after rigorous scrutiny by the WHO Strategic Advisory Group of Experts the vaccine can be used to help protect populations from the coronavirus pandemic.’
Sarah Gilbert, Professor of Vaccinology, and Chief Investigator on the Oxford vaccine trial, said:
‘It is excellent news that the WHO has recommended use of the SARS CoV-2 vaccine first produced in Oxford. This decision paves the way to more widespread use of the vaccine to protect people against COVID-19 and gain control of the pandemic.’
Notes to editors:
For further information 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
FAQ's
Regulatory authorisation
https://www.research.ox.ac.uk/Article/2020-12-30-oxford-vaccine-regulatory-faq
Phase 3 trial data
https://www.research.ox.ac.uk/Article/2020-12-08-phase-3-trial-data-publication-faq
Previous papers published on this project:
- 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.
- A booster dose enhances immunogenicity of the COVID-19 vaccine candidate ChAdOx1 nCoV-19 in aged mice. Lambe, Linterman et al. Med (2020).
- Intranasal ChAdOx1 nCoV-19/AZD1222 vaccination reduces shedding of SARS-CoV-2 D614G in rhesus macaques. Lambe, Munster et al. Pre-print bioRxiv (2021).
- ChAdOx1 nCoV-19 protection against SARS-CoV-2 in rhesus macaque and ferret challenge models. Lambe, Spence et al. Pre-print ResearchSquare (2021).
- Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine. M Voysey, S A Costa Clemens et al. Pre-Print Preprints with THE LANCET (2021)
For detailed information about the vaccine trial: covid19vaccinetrial.co.uk
Images: Credit: University of Oxford, John Cairns
- Vaccine PI profiles: https://www.dropbox.com/sh/jpql3ofnoal1gz7/AABY1Kt9NytSrLcswhsK-SZGa?dl=0
- 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
About the Oxford COVID-19 vaccine
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.
Over 50,000 people to date have taken part in clinical trials of The ChAdOx1 nCoV-19 vaccine sponsored by the University of Oxford and AstraZeneca, and many more have received the vaccine through public vaccination programmes following emergency use licensure. It has been shown 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. In total, nearly 24,000 volunteers have joined the University of Oxford sponsored trial, in sites around the UK (approximately 12,000 volunteers), Brazil (approximately 10,000 volunteers) and South Africa (approximately 2,000 volunteers). Interim efficacy and safety data were published in The Lancet in December, including an extensive safety database of over 74,000 ‘person months’ of safety data follow-up.
Our partners, AstraZeneca, have committed to delivering billions of doses of its COVID-19 vaccine across the globe in a broad, equitable, and timely way at no profit during the pandemic. This includes an agreement with the European Commission to supply up to 400 million doses, starting in early 2021 following the regulatory approval from the European Medicines Agency, with tens of millions of doses due to be supplied in February and March.
For more information on this commitment, visit: https://www.astrazeneca.com/content/astraz/media-centre/articles/2021/astrazenecas-covid-19-vaccine-european-union-supply-commitment.html
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, with any future royalties received by the University of Oxford being re-invested in the medical sciences.
Oxford University
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