National Immunisation Schedule Evaluation Consortium (NISEC) II

Background The National Immunisation Schedule Evaluation Consortium (NISEC, www.nisec.ac.uk), was founded in 2018 to address knowledge gaps of relevance to the UK immunisation programme and to provide a new operating model to replace the National Vaccine Evaluation Consortium (NVEC), which had previously been hosted by Public Health England.

The infrastructure funding and collaborative nature of NISEC was key the team s ability to rapidly deliver mission-critical policy relevant vaccine studies during the COVID-19 pandemic, enrolling over 13000 participants to provide timely evidence on use of alternating COVID-19 vaccines, the response to booster vaccines and co-administration with influenza vaccines.

This work was conducted across a network of over 30 NIHR clinical trials sites and was extensively referenced in UK and World Health Organisation COVID-19 immunisation guidance, demonstrating the importance of a standing network conducting research on immunisation to provide the capability and capacity to response to (inter)national crises.

Aims and objectives NISEC is now applying for £6 million funding to continue its work on vaccine evaluation to inform UK policy questions, as determined by the UK Joint Committee for Vaccines and Immunisation (JCVI).

Methods We propose allocating £1.5 million to support core infrastructure critical for rapid trial delivery across NISEC including: project management database creation statistical support biobank development public and patient involvement and engagement including a focus on recruiting populations under-represented in research The remainder £4.5 million will consist of dedicated funding for specific immunisation policy-directed clinical trials.

Research workstreams will be directed by the NISEC Advisory Board, which will consist of The Chair of the JCVI, the UK Deputy Chief Medical Officer and representatives from the UK health Security Agency (UKHSA), Vaccine Task Force (VTF) and National Institute for Health and Care Research (NIHR).

Acknowledging that NISEC may again be required to deliver expedited largescale studies in the event of emergent health crises, we propose the following exemplar studies: Evaluation of higher valency pneumococcal conjugate vaccines (PCV15/PCV20) in mixed/reduced infant schedules Assessment of efficacy of recombinant shingles vaccine in immunocompromised adults Investigation of optimal COVID-19 boosting strategies in the elderly Developing core trial infrastructure for future pandemic responsiveness Supporting investigator-led manufacturer-funded studies to inform UK vaccine policy Anticipated impact and dissemination All data will be published in Open Access peer-reviewed academic journals.

NISEC studies will address critical knowledge gaps in the cost-effective use of new and existing vaccine, providing evidence to optimise immunisation schedules in multiple age groups. This in turn will lead to improved protection against vaccine preventable infectious diseases across the UK.