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Data from NIHR-supported studies inform UK COVID-19 Booster Programme

Data drawn from a collection of National Institute for Health Research-supported COVID-19 vaccine studies has informed key decisions made for the UK’s booster programme.

This week, the Joint Committee on Vaccination and Immunisation (JCVI) updated its advice on the COVID-19 vaccine booster programme, and based their views on early data from the COV-BOOST study, which was run at 18 NIHR sites across England, Scotland and Wales.

Backed by £19.3 million of government funding through the Vaccines Taskforce and supported by the NIHR-funded National Vaccination Immunisation Evaluation Consortium (NISEC), COV-BOOST is the first study in the world to provide vital data on the impact of a third vaccine dose on patients’ immune responses.

Initial data made available to the JCVI indicates that booster doses of COVID-19 vaccines are generally well tolerated and provide a substantial increase in vaccine-induced immune responses. In particular, mRNA vaccines provide a strong booster effect, regardless of whether the primary course was with the Pfizer-BioNTech or the Oxford-AstraZeneca vaccine.

The COV-BOOST trial studied the use of seven different COVID-19 vaccines when given as a third ‘booster’ dose, including three of them also as a half dose, on participants representative of the UK population who have received COVID vaccine - those who had had two doses of Oxford-AstraZeneca or Pfizer-BioNTech.

The JCVI advises a preference for the Pfizer-BioNTech vaccine for the booster programme, regardless of which vaccine brand someone received for their primary doses. This follows data from the COV-BOOST trial that indicates the Pfizer-BioNTech vaccine is well tolerated as a third dose and provides a strong booster response.

Alternatively, a half dose of the Moderna vaccine may be offered. Where mRNA vaccines cannot be offered, for example due to allergies, the Oxford-AstraZeneca vaccine may be considered for those who received it previously.

COVID and flu jabs co-administered

The ComFluCov trial indicates that co-administration of the influenza and COVID-19 vaccines is generally well tolerated with no reduction in immune response to either vaccine. Therefore, the two vaccines may be co-administered where operationally practical. The NIHR-funded study assessed the use of both the Oxford-AstraZeneca and Pfizer-BioNTech vaccines, and was run at 12 sites.

The ComFluCov study looked at the safety, side effects and immune responses of administering the most widely used COVID-19 and influenza vaccines at the same appointment, with one vaccine given in each arm. A paper based on this report will be submitted to a peer reviewed medical journal and the findings shared publicly in due course.

Professor Saul Faust, Chief Investigator of the COV-BOOST study, said:

“The COV-BOOST study has given the JCVI important initial data to inform their recommendations of which vaccine may be safe and effective to use in any autumn/winter booster campaign to protect the population against COVID-19, as we move towards the winter.

“The 2,883 participants in the study have played a vital role in understanding how we can best protect people against future infections. The JCVI and MHRA have received early data from the COV-BOOST study on the vaccines currently available in the UK vaccine programme, and the study team will continue to analyse and generate data around different booster vaccine schedules, with a paper for public review available in due course.”

Professor Andrew Ustianowski, NIHR Clinical Lead for COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said:

“The important data provided to the JCVI could not have been made possible without the efforts and altruism of the research participants taking part in various booster studies across the UK.

“We are very grateful to the huge number of volunteers and research staff across the UK who are helping to provide key study data which informs these important decisions.”

Professor Matthew Snape, Chief Investigator on the Com-Cov trial, said:

"Thanks to the Com-Cov study, we know that the combination of different first and second schedule doses produce immune responses to prevent future COVID-19 infections, and this has helped play a role in the JCVI’s advice.

“The contribution from volunteers throughout the UK has been invaluable and will continue to help us to identify further data to support future vaccine booster guidelines.” 

Dr Rajeka Lazarus, Chief Investigator of the ComFluCov study, said:

"The results from the ComFluCov study have helped inform MHRA, JCVI and WHO recommendations for the coming season. The result should mean that people receive the vaccines they need in a timely manner and reduce the number of appointments needed, reducing the burden on healthcare providers."

Initial data from the COV-BOOST study has been provided to JCVI as part of its decision-making for the autumn booster campaign. The full results from the study will be published in due course. Any questions related to this initial data should be directed to JCVI.

Further information from Public Health England and the MHRA has been issued around the statement.

Both the COV-BOOST and Com-Cov studies used the NHS COVID Vaccine Research Registry, to help promote the trials to a database of research engaged members of the public. Those interested in finding out more about booster vaccine studies and volunteer to be contacted about taking part in trials can sign-up to the NHS COVID-19 Vaccine Research Registry.