In another significant step forward in the development of an effective vaccine to combat the Covid-19 virus, a vaccine candidate being developed by the University of Oxford has published data from its clinical trial in peer-review literature.
Publishing in The Lancet, it becomes the first vaccine candidate worldwide to publish the results of its phase 3 trial in a peer-reviewed journal; typically seen as a mark of validity for the data gathered.
The research team for the NIHR-funded and supported vaccine have presented a pooled analysis of phase 3 trials of a vaccine against Covid-19 across two different dose regimens, resulting in an overall vaccine efficacy of 70.4% at least 14 days after the second dose.
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.
This data draws on 11,636 volunteers across the UK and Brazil, and combined across the three groups of people vaccinated.
No hospitalisations or severe disease were observed among participants in any of 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 eight months to bring us to this milestone.”
Professor Sarah Gilbert, Professor of Vaccinology at the University of Oxford, added: ““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.”
Researchers also investigated the potential for the vaccine to prevent asymptomatic disease, through the use of weekly swabbing by UK trial volunteers.
The initial data from this appears to 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.