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, which recruited 140 patients across Devon and Cornwall, 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 David Tucker, Consultant Haematologist at Royal Cornwall Hospitals NHS Trust and Principal Investigator for the study locally, said: “This study has shown that it is safe and effective to give both the COVID-19 and Common Flu vaccines at the same time. It has answered a really important scientific question and involved a wide range of people using a variety of COVID vaccines. As well as being safe, it also showed that the antibody responses are not affected by giving them together. It will help the NHS protect people from both infections more efficiently over the winter months. We are really grateful to everyone who took part.”
Dr Nick Jacobsen, Primary Care Research Lead for Cornwall for the Clinical Research Network South West Peninsula, and Principal Investigator for the study at Newquay Health Centre, said: “The results of the ComFluCov study are a fantastic step forward in the battle against the Covid-19 pandemic. We can now confidently give flu and Covid-19 boosters together improving the quality of care for our patients and population whilst enabling effective and efficient use of NHS resources. Very well done to the trial team.”
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.”
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.”