World Health Organization experts provide guidance on use of the Oxford vaccine

• 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.’

ENDS

Notes to editors:

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-printResearchSquare (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)