MSD fully funded and attended the roundtable meeting. The report ‘Measuring vaccine induced immunogenicity: Leveraging a COVID-19 legacy for improved public health’, was fully funded by MSD and was fact checked for accuracy and balance only.
In this article, Dr Ulrike Buchwald (MSD Research Laboratories) and Andrew Tran (MSD UK) reflect on the findings of the ‘Measuring vaccine-induced immunogenicity: Leveraging a COVID-19 legacy for improved public health’ policy report, published by the BSI.1 Hear their thoughts on the report’s key findings and recommendations on the necessary steps to keep building momentum below.
The roundtable on ‘Measuring vaccine induced immunogenicity: Leveraging a COVID-19 legacy for improved public health’ was an initiative that brought together experts in vaccinology and immunology, policymakers, regulators and industry to discuss how to build upon learnings from the COVID-19 pandemic, with a focus on how to unlock immunogenicity measurements as a key tool to improving the vaccine development pipeline. The subsequent report sets out recommendations to guide research and policy agendas which will ultimately benefit populations and strengthen our pandemic preparedness.
There are three broad conclusions from the report that will be essential in preparing the public for future pandemics:
- The importance of cross-sector collaboration
- Prioritising further immunogenicity research
- Protecting people who are immunocompromised/immunosuppressed
Continuing to drive progress in these areas will help to ensure that the UK is best prepared to respond rapidly and robustly to infectious threats and protect those who are most vulnerable in our population.
The report recommends that continued immunogenicity research should be recognised as a central component of the UK’s pandemic preparedness plans.
Cross-sector collaboration
Lessons learned from the COVID-19 pandemic laid bare the importance of close and effective collaboration between stakeholders across public and private sectors to ensure successful vaccine development. The precedent set during the pandemic was of unparalleled magnitude, but various barriers to collaboration remain. Cross-pollination of perspectives and expertise will lead the way to a better understanding of the unique challenges and needs that each group of stakeholders may face.
Importantly, there needs to be clarity around who holds a particular remit, and where best practice already exists. The report emphasises that an important next step to achieve this is producing a centralised map of the UK’s academic innovation and capacity and developing a virtual biobank of samples stored in UK laboratories. Improving coordination this way would enable industry to better identify areas for focused resource investment and research efforts. One of the core UK Health Security Agency (UKHSA) priorities is to invest in efficient and long-lasting data and technology infrastructure to develop pathogen genomics and surveillance capabilities.2
The remarkable ability of the UK’s vaccinology community to rapidly translate and adopt clinical research remains fresh in our minds, with the work of research consortia during the pandemic, including the UK Coronavirus Immunology Consortium (UK-CIC) as a stellar example. However, collaborative spaces of this kind can only operate effectively with strong support and leadership from the government, who must oversee the establishment of a centralised portal and formal routes for knowledge transfer. The potential benefits of greater data transparency are huge, and would help to aid collaboration between stakeholders in this area.
Prioritising further immunogenicity research
Moving forward, the expert panel recognised immunogenicity research should be a central part of the UK’s pandemic preparedness plans. Bolstering the understanding of the ways that immune responses to infection and vaccination are best measured will support decisionmakers in evaluating the effectiveness and value of vaccines to society.
One example of this is the panel’s recommendation to ensure that immunogenicity assays are considered alongside clinical outcome measures in licensing evaluations for vaccines. Assays provide an essential tool for regulatory agencies to evaluate the safety, efficacy and quality of vaccines for licensure, and for policymakers to estimate the impact of a vaccine on individuals and public health. As specific immune responses to infection and vaccination vary between pathogens, measuring immunogenicity in standardised and scalable assays can be difficult. Given this, driving forward our research in this area can provide future benefits in informing post-marketing surveillance studies and our ability to monitor different demographics.
Another key focus area of the panel’s report is mucosal immunity – the immunological response that forms in the body’s mucous membranes in response to exposure to and infection with microbes. Mucosal immune responses harbour vast promise for further research into vaccines that can prevent onward transmission and reduce the public health burden of infections, especially respiratory infections. With lessons from the pandemic in mind, the panel encourages to direct research towards a better understanding of mucosal immune responses and develop methods to better evaluate vaccines for their potential to provide sterilising immunity and indirect protection to the community.
Protecting people with weakened immune systems
One of the report’s key focuses is around ensuring how to prioritise protection of the most vulnerable groups in the population, including those who are immunocompromised. There are many heterogeneous conditions that can lead to or be associated with a compromised immune system and immune responses. Therefore, the number of patients living with a specific condition is often small, which can limit our understanding of the potential impact on the course of infection and/or the response to vaccination. At-risk groups are also commonly underrepresented in vaccine licensing studies. A crucial next step towards furthering knowledge in this area is increasing the inclusion of people who are immunocompromised or immunosuppressed in clinical trials to better understand vaccine-induced immunogenicity in these groups, and provide clinicians with the evidence needed for clinical decision-making.
To generate the required participant numbers, the panel outlines the need for more large-scale studies. An example of this is the 2023 OCTAVE study to determine vaccine immunogenicity in these groups.3 Funded by the Medical Research Council and with advocacy from the BSI, the OCTAVE trial studied post-SARS-CoV-2 vaccination immune responses in patients who are immunocompromised, with findings reporting a low or undetectable immune response for many of these patient groups.3 While the study further highlighted the urgent need for focused research in this area, its data crucially helped to inform changes to recommendations for people who are immunocompromised or immunosuppressed to ensure they received a prevention programme tailored to their specific needs.
Collaboration is key for the future of immunogenicity research
Irrespective of the specific focus, each of the report’s recommendations are underpinned by one overarching theme: the need to nurture collaboration and draw on the different areas of expertise in vaccinology, immunology, policymaking, regulatory authorities and industry to drive solutions. Key questions and challenges still exist within the field of immunogenicity, but the potential that could be harnessed is vast.
At MSD, we are continuing to work with experts from all these different sectors, who share our vision and passion towards driving progress in the field of immunology and vaccinology. It is our vision to continue to work together to build upon the foundation of excellence laid throughout the COVID-19 pandemic and ensure that long-term benefits can be delivered to those who need it most in society.
Dr Ulrike Buchwald, Section Head Pneumococcal Vaccines in Global Clinical Development, MSD Research Laboratories
Andrew Tran, Senior Medical Manager for Pneumococcal Vaccines, MSD UK
Date of Prep: September 2023 | GB-NON-07855
References
- British Society for Immunology 2023 Measuring vaccine-induced immunogenicity: Leveraging a COVID-19 legacy for improved public health. bit.ly/48UrG18
- Gov.UK 2023 Letter from Maria Caulfield MP to Professor Dame Jenny Harries, UKHSA chief executive.
- Barnes et al. 2023 Nat Med 29 1760–1774. DOI: 10.1038/s41591-023-02414-4