Oxford researchers are hoping their Covid vaccine will ‘shortly’ be in use, as the first peer-reviewed findings from its phase 3 trials were published today.
Regulators are now evaluating the findings – which reiterated that it is safe and effective – with a view to potentially granting the vaccine an emergency license.
However, questions still remain about the dosage of the Oxford vaccine.
The study, published today in the Lancet, reiterated findings that it is 70% effective ‘from a pooled analysis of a two-dose regimen’.
But this includes findings of 62% efficacy for people receiving two full doses and 90% efficacy for people receiving a lower dose at the first vaccination opportunity.
Regarding safety, the trials including over 23,000 volunteers in the UK, Brazil and South Africa found only three serious adverse events were reported.
One of these was ‘possibly related’ to the Oxford Covid vaccine, another was in the control group and a third was considered an ‘expected vaccine-related event’, researchers said.
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.’
AstraZeneca CEO Pascal Soriot said: ‘Today’s peer-reviewed publication enables a full disclosure of the Oxford program interim analysis. The results show that the vaccine is effective against Covid-19, with in particular no severe infections and no hospitalisations in the vaccine group, as well as safe and well tolerated.
‘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.’
The news comes after the MHRA granted emergency approval to the first Covid-19 vaccine, created by Pfizer and BioNTech, last week.
Professor Azeem Majeed, professor of primary care at Imperial College London, told Pulse that the Oxford trial results were ‘encouraging’, despite the lower efficacy compared to the other vaccines that have reported findings to date.
He said: ‘The AstraZeneca vaccine is cheaper than the mRNA vaccines and can be stored in a conventional vaccine fridge. Hence, it is easier to roll out in primary care and community settings, including in low and middle income countries. Based on these results, once the vaccine is approved, I would like to see if rapidly adopted by the NHS.
‘There is ongoing research looking at vaccine combinations and if this research shows positive results, people may benefit from a second vaccine, such as an mRNA vaccine, after receiving an adenoviral vaccine. One caveat for all the vaccines is that we don’t yet know how long the immunity they generate will last and also wether it stops people being infectious.
‘The most commonly reported adverse reactions were fatigue, headache, feverishness, and myalgia. More serious adverse events have occurred in 13 people, none of which were thought to be due to either of the vaccines used in the study.’