The Government has today (Wednesday 30 December) accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s COVID-19 vaccine for use.
The decision follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness. But today’s news is also the culmination of a collaborative effort of many people and organisations working together to drive progress in vaccine research.
The Health Research Authority is proud to have played an important role in the Oxford/AstraZeneca vaccine being authorised, and to see that it will now be able to deliver benefits to even more people.
The study went through our fast-track process and saw our South Central Berkshire Research Ethics Committee meet virtually to review the initial application for the study. The committee also approved a second stage of the trial and has reviewed 17 amendments to the study to date – often during the evening or at weekends – and in record time.
Professor Sir Terence Stephenson, chair of the Health Research Authority
‘We are delighted to hear that the MHRA has approved the Oxford/AstraZeneca coronavirus vaccine. This is a great moment for UK research.
‘The HRA is proud to have played an important role in this vaccine research - reviewing the original applications from the University of Oxford and subsequent amendments - to ensure that high quality research could happen quickly and generate the data that MHRA needed for the licensing process.
‘I am proud of the HRA staff and volunteers who have given so much this year to do this at speed while ensuring we protect and promote the interests of patients and the public. This speed has not come at the expense of scrutiny. Staff and volunteers have worked around the clock to ensure that their part of the process could be completed as quickly as possible. In normal times for example, applications submitted to the HRA for ethics review may be delayed as we wait for responses to follow-up questions put to researchers. During the pandemic, responses have been almost instant. And once approvals were granted there has been no delay in recruiting to studies as volunteers signed up in the tens of thousands. Combined, these factors mean that research has been able to race along.
‘The HRA’s vision is for high-quality health and social care research that improves people’s health and wellbeing and this is definitely a real success story for British life sciences.’
Dr Janet Messer, HRA Director of Approvals Service
‘The news today of the authorisation of the Oxford coronavirus vaccine for emergency use in the UK is the culmination of great clinical research by huge numbers of people working collaboratively. The vaccine team at the University of Oxford is very experienced and designed a really efficient programme of trials that removed all possible delays.
‘Normally researchers will wait for the results of one stage of trial before planning the next stage. The Oxford team overlapped the preparation and logistics so that as soon as enough information from one stage was available, everything was ready for patients to take part in the next stage.
‘Before the trials could start, they were reviewed by one of the Health Research Authority’s Research Ethics Committees as well as by the Medicines and Healthcare products Regulatory Agency. The committee that reviewed these trials is experienced in reviewing vaccine studies. We are enormously grateful to them and all our other volunteer ethics committee members, supported by our staff, who have dropped everything to make time to review the COVID-19 research studies so quickly and robustly.’
David Carpenter, Chair of the South Central Berkshire Research Ethics Committee, who reviewed the University of Oxford vaccine study
‘The Oxford vaccine study was one of the first to benefit from the HRA’s strategy to respond quickly to applications for ethics reviews of urgent COVID -19 related research. This strategy aimed to achieve rapid review whilst not compromising well-established standards of research ethics. Following this strategy South Central Berkshire REC met virtually, at very short notice, as a full ad hoc committee, to expedite review of the Oxford study. Committee members sacrificed evenings and weekends preparing for the review and I am extremely grateful for the work they undertook and continue to provide as further research develops.
'Whilst maintaining complete independence, the committee worked collaboratively with researchers believing that ethics review would extend beyond a single approval event to a continuing partnership, ensuring ethical conduct of the research. This approach has been particularly important in the management of substantial amendments which have, perfectly understandably, been numerous. It was not unusual for the study team to provide a few hour’s warning of an impending amendment, often on a Friday morning. Formal paperwork was often submitted later in the afternoon or early evening. The sub-committee typically responded immediately, providing an opinion within an hour or two. This rapid turnaround was not just a result of committee efficiency; credit should also be given to the study team for the high quality of paperwork which was consistently provided.
'Today’s news is very exciting for all involved, however I am mindful that it is a beginning rather than an end. The research is ongoing, the trial will keep developing and amendments will continue as a result of those developments. Most importantly further research will be necessary, and I look forward to a continuing strong relationship with the study team. It is a privilege to be a regulatory partner in research which is of such public benefit.’
The HRA also assembled a Zoom meeting for relevant REC chairs over a weekend to advise the National Institute for Health Research (NIHR) and to ensure that the arrangements for vaccine trial participants to access vaccines in the national roll-out are reasonable and fair.