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Dr. Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner Institute. Fellow and advisor of Clinical Medicine at Kellogg College, University of Oxford, UK

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Page 1: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

Dr. Ahmed M. SalmanDoctor and Instructor of Immunology and Vaccinology at The Jenner Institute.

Fellow and advisor of Clinical Medicine at Kellogg College, University of Oxford, UK

Page 2: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19). SARS-CoV-2 is a positive-sense single-stranded RNA virus.

- It mainly enters human cells by binding to the receptor angiotensin converting enzyme 2 (ACE2) by the RBD of the spike protein of SARS-CoV-2.

- The genome size of the SARS-CoV-2 varies from ≈ 30kb, including 11 genes.- Each SARS-CoV-2 virion is 50–200 nanometres in diameter.

(Khailany, Safdar et al. 2020) and (Chen, Zhou et al. 2020)https://www.ovg.ox.ac.uk/news/covid-19-vaccine-development

SARS-CoV-2 or nCOV-19 (virus)

Page 3: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

Modified from Professor Adrian Hill talk, published online on May 23, 2020, and https://bioprocessintl.com

- Replication-deficient simian chimpanzee adenoviral vector vaccine expressing nCOV-19 Spike protein.

- ChAdOx1 Viral vector, used in 12 phase I studies, 330 subject vaccinated with highsafety and immunogenicity.

- Non-enveloped dsDNA virus, 90nm.- ≈ 40kb, including 40 genes.- Non-replicable due to E1 (and E3)gene deletion.

History of ChAd(s)

- 2002: ChAd68 assessed in miceat Wistar Institute, U.S.- 2007: First ChAd clinical trials inOxford with Okairos for Malaria.- 2012: Oxford Uni. Develops bothChAdOx1 & ChAdOx2 at the Jenner Inst.

22 vectors in total in > 6,500 subjects;

Very good safety profile

ChAdOx1 nCoV-19 Oxford Viral Vector Vaccine

Page 4: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

ChAdOx1 nCoV-19 Oxford Viral Vector Vaccine

SARS-CoV-2(Virus, Pathogen)

SARS-CoV-2 Virus vs ChAdOx1 Oxford VaccineChAdOx1 nCoV-19 Oxford Viral Vector Vaccine is the most advanced vaccine in clinical trials, which is months ahead of any other vaccines against the SARS-COV-2.It is a replication-deficient simian chimpanzee adenoviral vector vaccine expressing SARS-CoV-2 Spike protein.

Page 5: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

ChAdOx1 nCoV-19 Oxford Vaccine Progress History

On December 2019:A new coronavirus disease (COVID-19) causing respiratory symptoms wasfirst identified in China.

Early January; 11 Jan, 2020Chinese researchers reveal draft genome of virus implicated in Wuhanpneumonia outbreak.

Late January, 2020First GMP batch manufacture of ChAdOx1 CoV-SARS-2 vaccines started inOxford Clinical Bio-manufacturing Facility (CBF) at the University of Oxfordand made after 6 weeks. That was enough for Phase I/II clinical trials.

Late February/Early March, 2020ChAdOx1 CoV-SARS-2 vaccines pre-clinical trials started in mice andmonkeys.

Page 6: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

On 11 March 2020The World Health Organization declared the outbreak of COVID-19 a pandemic; this means COVID-19 has spread worldwide.

Late April/Early May, 2020The pre-clinical trials in mice and monkeys results were obtained andpublished in a scientific manuscript at bioRvix Journal, entitled:“ChAdOx1 nCoV-19 vaccination prevents SARS-CoV-2 pneumonia inrhesus macaques”

WHO, 12-03-2020

(van Doremalen et al., 2020)

Scientists at the Jenner Institute, University of Oxford started toprepare for mass clinical trials, where the new tests show theirvaccine to be effective in monkeys.

By David D. Kirkpatrick, May 2, 2020, The New York Times

March, 2020In parallel, GMP batch manufacture of ChAdOx1 CoV-SARS-2 vaccinesstarted in Advent, Italy and made about +6,000 doses by late May, 2020for Phase II/III clinical trials.

Page 7: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

On 23 April 2020ChAdOx1 CoV-SARS-2 Oxford vaccine was approved for clinical trials and First patients injected in UK vaccine Phase-1 trial.

By Fergus Walsh, April 23, 2020, BBC News

Modified from Professor Adrian Hill talk, published online on May 23, 2020

Page 8: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

Modified from Professor Adrian Hill talk, published online on May 23, 2020,

Modified from Professor Sarah Gilbert talk, published online on June 17, 2020, and https://www.ovg.ox.ac.uk/news

LAST UPDATES - Till 1 July 2020Phase-3 Clinical trial design

In United Kingdom, 22 May 2020

In Brazil, 1 July 2020Trial of Oxford COVID-19 vaccine starts in Brazil. Aiming for 4,000 Volunteers

In South Africa, 1 July 2020Trial of Oxford COVID-19 vaccine starts in South Africa. Aiming for 2,000 Volunteers

In USA, Future planLarge Phase-3 trail in USA b y AstraZeneca. Aiming for 30,000 Volunteers

Page 9: Dr.Ahmed M. Salmanstatic.alarabiya.net/files/PDF/2020/07/18/ec38bc0a-ed27... · 2020-07-18 · Dr.Ahmed M. Salman Doctor and Instructor of Immunology and Vaccinology at The Jenner

LAST UPDATES - Till 1 July 2020Funders:The agreement with CEPI and Gavi also represents the first advanced marketcommitment through the Access to COVID-19 Tools (ACT) Accelerator, a globalmechanism co-chaired by the Bill & Melinda Gates Foundation and the WorldHealth Organisation (WHO). Major funders as:- Bill & Melinda Gates Foundation ($750M).- Governments: U.S. Gov. ($1.2B) and UK Gov. (£388M).

The University of Oxford in partnership with:

- Oxford/AstraZeneca

- Serum Institute of India (SII), India(for low-and-middle-income countries)

- Cobra in UK, Halix in NL,Wuxi in China and OXB in Oxford, UK

The Univeristy of Oxford webpage, 1 July, 2020

≈ 2 million doses

≈ 400M doses, end of 2020.≈ up to 2B doses, within 2 years

≈ 30M doses, Sept. 2020≈ +300M doses, end of 2020 to UK/USA≈ +400M doses, end of 2020 to Europe≈ up to 2B doses, within 2 years