COVID-19 ComFluCov Vaccine Study
Researchers at the Bristol Trials Centre (CTEU) at the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) are leading a new study which could set the foundations for how booster COVID-19 vaccinations are delivered in the future.
The study, supported by the National Institute for Health Research (NIHR), will determine whether booster COVID-19 vaccines should be given at the same time as flu vaccines.
While there are vaccines that have been approved to protect against COVID-19 in the UK, it is not yet known whether further booster doses may be required to give continued protection, and how giving boosters might fit in with the seasonal flu jab programme.
This study will be looking at the side effects and immune response given when people receive their COVID-19 booster and flu vaccine at the same appointment.
The study will involve people aged 18 years old or over who have received their first COVID-19 vaccination and are awaiting their second dose. It will look to recruit 504 participants across six NHS sites: Gloucestershire Hospitals NHS Foundation Trust, Great Western Hospitals NHS Foundation Trust, North Bristol NHS Trust, Royal Cornwall Hospitals NHS Trust, Royal United Hospitals Bath NHS Foundation Trust and UHBW.
Each participant will receive the second dose of the same COVID-19 vaccine they originally received, either the Pfizer/BioNTech COVID-19 vaccine or the Oxford/AstraZeneca COVID-19 vaccine.
Participants who are eligible to take part will then be allocated into one of two groups:
- One group will receive their second dose of the COVID-19 vaccine and the flu vaccine at their first visit, then a saline injection (placebo) at their second visit
- The other group will receive their second dose of the COVID-19 vaccine and a saline injection (placebo) at their first visit and then the flu vaccine at their second visit
Dr Rajeka Lazarus, a consultant in infectious diseases and microbiology at UHBW and Chief Investigator for the trial, said:
“With the challenges of immunising large numbers of people against COVID-19 and the need to continue the seasonal influenza vaccination schedule, this next phase of vital research will establish whether it’s possible for us to protect people from both of these viruses at the same appointment.
This would mean fewer appointments for those who need both vaccines, reducing the burden on those who have underlying health conditions and would usually be offered the influenza vaccine.
We particularly encourage people who would usually be offered the influenza vaccine, as individuals from across all communities, to volunteer to take part.”
Chris Rogers, Professor of Medical Statistics and Clinical Trials and Director of Bristol Trials Centre, said:
“We are delighted to be working with Dr Lazarus and UHBW to rapidly deliver this important research. The results will aid policy makers in planning the continuing vaccination programme.”
Rebecca Maxwell, Clinical Lead for vaccinations at UHBW, said:
“Receiving vaccinations is the most important thing we can do both to protect ourselves, reduce the spread of illness to vulnerable patient groups and therefore protect health services during outbreaks.
This important piece of research will enable us to potentially protect more people in society against both flu and COVID-19 in a timely manner, both of which have significant effects on those most vulnerable in society.
The success of both the flu campaign and the COVID-19 vaccine roll out this year has been impressive; this is the next step in helping us ensure protection for the public is achieved.”
Dr Lazarus added:
“Those taking part in this trial will play a crucial role in the global effort to continue to protect people from COVID-19, now and in the years to come.”
For more information about this study, visit the ComFluCOV Vaccine Trial website.
Study Results:
Is it safe for people to be vaccinated against COVID-19 and influenza at the same time?
Research has found that it is safe for people to receive a flu vaccine at the same time as a COVID-19 vaccine. Reported side effects were mainly mild to moderate, and there were no negative impacts on the immune response produced by either vaccine when both were given on the same day, in opposite arms.
The study was led by researchers at the Bristol Trials Centre, University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) and supported by the Clinical Research Network (CRN) West of England. It is funded by the National Institute for Health Research (NIHR), with the results due to be published in The Lancet.
Earlier in the pandemic, it was not known whether further booster doses of COVID-19 vaccines would be required to give continued protection, and how giving boosters may fit in with the seasonal flu vaccine programme.
The Combining Influenza and COVID-19 Vaccination (ComFluCOV) study looked to establish the safety of co-administering the most widely used COVID-19 and influenza vaccines in the UK and describe the expected side effects and immune responses to the vaccines when they are given together. Two COVID-19 and three influenza vaccines were tested, meaning six combinations in all.
Participants recruited to the study were over the age of 18 and had already received one dose of either the Pfizer/BioNTech or the Oxford/AstraZeneca COVID-19 vaccine and were awaiting their second dose.
A total of 679 volunteers took part in the study across 12 NHS sites in England and Wales, and were randomly allocated into one of two groups:
- A group who received their second dose of the COVID-19 vaccine and the flu vaccine at their first study visit, then a saline injection (placebo) at their second visit
- A group who received their second dose of the COVID-19 vaccine and a saline injection (placebo) at their first visit and then the flu vaccine at their second visit.
Participants also attended a third study visit to discuss any side effects they experienced following their second appointment and to give a final blood sample.
The most common side effects were pain around the injection site and fatigue. With some combinations there was an increase in the number of people who reported at least one side effect when both COVID-19 and flu vaccine were given together, but the reactions were mostly mild or moderate.
The immune responses to both the influenza and COVID-19 vaccine were preserved when given together, and 97% of participants said they would be willing to have two vaccines at the same appointment in the future.
Dr Rajeka Lazarus, consultant in infectious diseases and microbiology at UHBW and Chief Investigator for the ComFluCOV study, said:
“By conducting this study we have been able to establish that it is possible to protect people from both COVID-19 and flu at the same appointment.
This is a really positive step which could mean fewer appointments for those who require both vaccines, reducing the burden on those who have underlying health conditions and would usually be offered the influenza vaccine.
The results of this study have been presented to the Joint Committee on Vaccination and Immunisation (JCVI) for their consideration and will aid policy makers in planning the future of these important vaccination programmes.”
Chris Rogers, Professor of Medical Statistics and Clinical Trials and Director of Bristol Trials Centre at the University of Bristol, said:
“We are delighted to have worked with Dr Lazarus to successfully deliver this important study and would like to thank all the volunteers who took part.
The quality of the data provided by participants was excellent. It is reassuring that the results suggest that there are no safety concerns when giving the COVID-19 and flu vaccines together”.
Professor Andrew Ustianowski, NIHR Clinical Lead for the COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said:
“This research has quickly provided important and reassuring results that could make vaccination more efficient for both patients and the NHS. I’m proud of NIHR’s role in funding this research that could help to control the COVID-19 pandemic through this upcoming winter.”
The full results of this study are now available to view on the Science Direct website.
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