Devon GPs thanked for their support in delivering Novavax vaccine study, as UK’s independent medicines regulator announces its approval

The Novavax vaccine, which was trialled in Exeter and Truro, has become the fifth COVID-19 vaccine authorised by the UK’s independent medicines regulator, after it was found to be 89.7% effective against COVID-19, prior to the Omicron variant emerged.

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Novavax’s COVID-19 vaccine for use in the UK.

This follows rigorous clinical trials supported by National Institute for Health Research 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.

The Novavax study is the largest ever double blind, placebo-controlled trial to be undertaken in the UK. It recruited over 15,000 participants in just over 2 months from 33 UK research sites, including more than 800 participants from the NIHR Patient Recruitment Centre: Exeter, based at the Royal Devon and Exeter NHS Foundation Trust, and Royal Cornwall Hospitals NHS Trust. It was the first phase 3 study for the US-based biotechnology firm Novavax’s vaccine anywhere in the world.

Clinicians across Devon have now thanked the GPs in the region who helped make the study possible.

Dr Lisa Gibbons, Primary Care Clinical Research Lead for the NIHR Clinical Research Network South West Peninsula, said: “The timing and set up for the study was very tight with a really short window of time to recruit a fairly large number of patients to a complex, new vaccine study and, at the same time, COVID-19 admissions were increasing and hospital-based research doctors and nurses were often being pulled away from research to support the frontline NHS COVID-19 response. There was a need for experienced doctors to recruit to the study and to support follow up of patients, and this is where the GPs in Devon really came into their own and helped us deliver this vital study.

“We used word of mouth to spread the news that we were going to be recruiting to the study locally and that we needed additional support. The response we got from GPs was amazing. We had support from GP trainees, those early in their careers, right up to retired GPs coming out of retirement to support the COVID-19 effort.  Some GPs were totally new to research while others were very experienced, but everyone stepped up and brought energy, enthusiasm and determination to be part of the vaccine research effort and for that I would like to say a huge thank you.”

Dr Thomas Burden, Respiratory Consultant at the Royal Devon and Exeter NHS Foundation Trust, said the key to the success of the Novavax study in Exeter was collaborative working with primary care colleagues.

“We had extensive conversations with primary care research leaders early and often and worked together to think of novel ways to recruit and find participants,” he said. “We incorporated the skills and enthusiasm of local GPs into the research delivery team for recruitment, organisational set up and data quality. The symptomatic pathway was an aspect that was uniquely suited to GP research clinicians and allowed us to address this potentially vexing challenge. Clinicians needed to be confident in safely assessing unwell patients with potential COVID and guide them both in terms of the research study and in terms of treatment and care.

“I am extremely grateful to Dr Craig Lunt, a GP trainee, who played a leading role in the delivery of this study and showed tremendous skill in this work. The entire medical leadership group are grateful to primary care and the whole network for adapting to the challenge.”

Cathyrn Love-Rouse, Project Manager for the NIHR Patient Recruitment Centre: Exeter, said the GP community played a crucial role in the delivery of the Novavax vaccine trial. She said: “Having a GP workforce has allowed great flexibility to offer different levels of input as the study has required at different stages. We had a huge amount of interest from the primary care community in supporting the trial and have many more GPs who expressed an interest. We are keeping in touch so we can build on this approach for potential future activity.”

The GPs involved in the trial in Exeter have said the opportunity provided them with the chance to learn new skills and to help support the pandemic response.

Dr Anna Turner, GP Imperial Medical practice Exmouth, said: “The experience gave me a wider understanding of how larger trials run and the skills I learnt will be really useful to help me offer research studies to my patients at my surgery.”

Dr Karen Barwise, Essex House Medical Centre, spent every Wednesday, her day off, working on the Novavax study. She said: “I volunteered so that I could contribute to the COVID research effort and because I thought it was really interesting. I hadn’t been involved in research before - I thoroughly enjoyed it and would be very keen to take part in research again in future.”

Dr Clare Lascelles, Hill Barton Surgery Exeter, was also new to research when the opportunity to get involved in the study arose. She said: “I felt like I was able to make a positive contribution in the pandemic effort. I feel I have learned a lot and enjoyed the teamwork and patient contact.”

Dr Tom Debenham, a senior GP with a great deal of healthcare management experience, came out of retirement to support vaccine research during the pandemic.  He said: “Working with experienced researchers and junior doctors has been a new type of work for me after 30 years as a GP. I was in my element when the more complicated patient scenarios developed.”

Dr Daisy Robinson, GP College Surgery, said: “This was a unique opportunity to join a large clinical trial as a member of the team building on and using the existing skills of GPs.  I would like to see direct trial delivery support opportunities made more widely available to GPs who may otherwise not see such large-scale randomised control trials in action - it can only build interest and confidence to engage more GPs in clinical research in the primary care settings and build peer research networks across primary and secondary care settings in the future.”