Published: 08 December 2020
Data from the NIHR-funded and supported ChAdOx1 nCoV-2019 vaccine, developed by University of Oxford and AstraZeneca, have today become the first Phase 3 trial results of a coronavirus vaccine to be published in peer-review literature.
Published in The Lancet, the research team have presented a pooled analysis of Phase 3 trials of a vaccine against SARS-CoV-2 across two different dose regimens, resulting in an overall vaccine efficacy at least 14 days after the second dose of 70.4%.
The sub-group receiving two standard doses showed 62.1% efficacy, while the sub group with one low dose and one standard dose demonstrated 90.0% efficacy.
The efficacy data are based on 11,636 volunteers across the United Kingdom and Brazil, and combined across three groups of people vaccinated. No hospitalisations or severe disease were observed in the vaccinated groups.
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford Vaccine Trial, said:
“Today, we have published the interim analysis of the phase III trial and show that this new vaccine has a good safety record and efficacy against the coronavirus. We are hugely grateful to our trial volunteers for working with us over the past 8 months to bring us to this milestone.”
Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, said:
“We have known for many years that adenoviral vectored vaccines fulfil the requirements for use against outbreak or pandemic diseases. They are safe, highly immunogenic, can be manufactured in large quantities at low cost and do not require frozen storage. Following the demonstration of vaccine efficacy in many preclinical studies, we now have clear evidence of efficacy in the trial results presented in a peer-reviewed publication today. Now under regulatory review, we hope that this vaccine will shortly be in use to start saving lives.”
The researchers also investigated the potential for the vaccine to prevent asymptomatic disease, through the use of weekly swabbing by UK trial volunteers. These data indicate that the low dose / standard dose vaccine may provide a protection against asymptomatic infection, but stress that these data are at an early phase, with too high a level of uncertainty to be certain that this vaccine will protect against asymptomatic infection.
Pascal Soriot, Chief Executive Officer, said:
“We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit.”