he game-changing Oxford vaccination could get the go-ahead “just after Christmas”, a leading expert has said .
John Bell, Regius Professor of Medicine at Oxford University, stressed the data behind the jab is looking “better than ever”.
The Medicines and Healthcare products Regulatory Agency is examining the vaccine developed by Oxford University and pharmaceutical giant AstraZeneca.
With an announcement from the MHRA eagerly anticipated, Prof Bell told BBC Radio 4’s Today programme on Wednesday : “We are getting to be about prime time now.
“I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.
“And I have no concerns whatsoever, the data looks better than ever.”
Concerns had been raised by some people over the Oxford vaccine after the team developing it discovered by accident that using a half first dose was more effective than a full first dose, though this trial was on a smaller group and did not include elderly people.
However, Prof Bell played down the likelihood of a delay in the MHRA making a decision as it has been receiving the data as the trials took place so it could carry out a “rolling review”, and was aware of the half-dose development.
He added: “It took about three weeks to get the Pfizer vaccine launched.
“It will take about three weeks from the last data that the MHRA received from AstraZeneca.”
If the Oxford jab gets the go-ahead it could dramatically speed up the vaccination programme in the UK as the Government has ordered 100 million doses.
Ministers have also ordered 40 million doses of the Pfizer/BioNTech jab but it has to be stored at minus 70 degrees Centigrade so is far harder to administer.
The Oxford vaccine will in particular be easier for GPs to use and to adminster to elderly people in care homes.
It is also manufactured in the UK so will not have to be imported from Belgium like the Pfizer doses.
The two-dose Pfizer vaccine gives protection in 95 per cent of people, according to the research.
The half-dose/full dose Oxford vaccination was found to protect in 90 per cent of cases, and 62 per cent for two full doses.
Even if it was 62 per cent, such a level of protection could play a major role in ensuring herd immunity from the virus in the country.
Communities Secretary Robert Jenrick said giving people a first dose of the Pfizer vaccine is the “priority” at the moment and that how it is rolled out would be kept “under review”.
He told BBC Radio 4’s Today programme: “At the moment the priority is just to ensure that as many people as possible get the first shot of the vaccination.
“Remember, the second shot has to be done, depending on what the vaccine is, within 21 or 28 days later.
“And so we still have not reached that point with the first people who were vaccinated.”
Pressed on whether the Government might change course and adopt a one-jab policy, he added: “Our priority today is to get as many people vaccinated as possible with the first shot of the vaccine which we are doing a fairly good job.
“We have got half a million people or more who have been vaccinated so far, that is more than any country in the world.”
Asked again whether a one-jab programme may be brought in, he responded: “The strategy will obviously be kept under review.”
University of Oxford and AstraZeneca researchers present a pooled analysis of Phase 3 trials of a vaccine against SARS-CoV-2 across two different dose regimens, resulting in an average efficacy of 70.4%.
The new study published in the Lancet is the first peer-reviewed publication of phase 3 data from studies of a vaccine against the coronavirus.
The efficacy data are based on 11,636 volunteers across the United Kingdom and Brazil, and combined across three groups of people vaccinated – two groups who received a standard dose prime vaccination followed by a standard dose booster vaccination and one group (in the UK only) who received a low dose prime vaccination followed by a standard dose vaccination.
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.’
The pooled analysis in the study shows that the overall vaccine efficacy at least 14 days after the second dose was 70.4%; the standard dose / standard dose sub-groups showing 62.1% efficacy, and with the low dose / standard dose sub-group demonstrating 90.0% efficacy. No hospitalisations or severe disease were observed in the vaccinated groups.
The authors further report on an extensive safety database from volunteers in the UK, Brazil and South Africa accompanying the efficacy findings; of 23,848 trial volunteers, and over 74,000 ‘person-months’ of safety follow up, only three from 175 reported serious adverse events were possibly related to the vaccine. The trial protocols, and statistical analysis method are presented in the appendices to the paper.
Of these, one was considered ‘possibly related’ to the ChAdOx1 nCoV-19 vaccine, one occurred in the control group, and a further case of severe fever in the vaccinated group was considered to be an expected vaccine-related event.
Of the 11,636 volunteers in the UK and Brazil included in this initial analysis of efficacy, the majority are in the 18-55 age range (UK 87% and Brazil 90%), with those aged 56 or older contributing 12%. As only five cases included in the primary analysis occurred in those who were more than 55 years old, the vaccine efficacy in older age groups could not be assessed but will be determined in future analyses after more cases have accrued in this age range.
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: ‘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.’