Measuring vaccine-induced immunogenicity: Leveraging a COVID-19 legacy for improved public health

In April, the BSI published a new policy report which calls for further study of immunogenicity to improve the evaluation of the effectiveness and value of vaccines for the advancement of public health. We then met with policymakers, regulators, clinicians, researchers and industry at Parliament to present this report and explore the actions needed to leverage immunogenicity progress to protect and boost health for future generations. Here, our Policy and Public Affairs Manager, Matthew Gibbard, discusses the importance of the report, and its development and subsequent launch.

Pandemic preparedness

Borne out of roundtable discussions with experts from academia, industry, government, regulators and clinical medicine, the BSI report ‘Measuring vaccine-induced immunogenicity: Leveraging a COVID-19 legacy for improved public health’ lays out recommended interventions to cement the legacy from COVID-19 and ultimately, bolster the UK’s pandemic preparedness and greatly benefit the NHS and the public.

The rapid development and deployment of vaccines during the COVID-19 pandemic enabled unprecedented scrutiny of the immune response following vaccination.

This has begun to permit us a better understanding of the components of immunity that confer short- and longer-term protection. There have also been parallel advances in the development of novel research and routine clinical diagnostic devices to measure elements of this immune response.

Lessons to be learned

The UK is at a critical juncture to learn lessons from the COVID-19 pandemic, to reform regulatory decision-making and clinical trial design. We have the opportunity to make vaccine development cheaper and easier to conduct, as well as continue point of care and home testing for immunogenicity as a legacy of COVID-19 to bridge the divide to real-world data. Utilising immunogenicity as a tool is key to all this potential progress.

We have a duty to build on the legacy from COVID-19 throughout science, research infrastructure and innovative working, and deliver the long-term benefits we know are possible to both patients and the country’s wider public health. The key to securing this legacy will be the adoption of the recommendations that we have made in our report, to support future vaccine development and implementation by breaking down barriers between academia, industry, clinical medicine, regulators and government.

Professor Alex Richter, Chair of the roundtable for this report and Director of the Clinical Immunology Service at the University of Birmingham said:

This British Society for Immunology report explains how we can unlock immunogenicity’s full potential by breaking down barriers between academia, industry, clinical medicine, regulators and government, and investing in our R&D sector to ensure that we have the funding, skills and capacity to leverage the legacy of COVID-19 for the ultimate benefits of public health and pandemic preparedness.

A welcome reception

To ensure the report’s visibility among parliamentarians, the research community, and those who work in the science policy sphere, the BSI launched the report at an afternoon reception in the House of Lords. The event was kindly sponsored by the Lord Patel of Dunkeld KT, a physician and the former Chair of the House of Lords Science and Technology Select Committee. The meeting was fully funded by MSD.

Lord Kakkar, an eminent cardiovascular surgeon and former member of the Science and Technology Select Committee, spoke first to launch the report, welcoming the parliamentarians and scientists to the event, while highlighting the importance of immunology in improving public health. He noted that the accelerated progress in vaccine development from COVID-19 has led to an increased understanding of the immune response components that confer short- and longer-term protection from infection and disease severity.

Importance of immunogenicity

Professor Alex Richter, Director of the Clinical Immunology Service at the University of Birmingham, who chaired the roundtable which formed the basis of the report, then addressed the audience. In her speech, she discussed the challenges and opportunities of measuring immunogenicity and talked through the report’s recommendations, how they link into each other, and how they will ultimately be able to come together to improve public health and the UK’s pandemic preparedness.

Dr Dilruwan Herath, medical director at MSD, also spoke at the event. In his speech, Dr Herath discussed the role of industry and noted that MSD is committed to supporting research that can help to improve the understanding of immunogenicity.

Attended by a wide range of stakeholders, including policymakers, researchers, industry, regulators, and clinicians, the afternoon reception provided an opportunity to discuss the importance of immunogenicity research in a post-pandemic world, as well as to share their views on the report and its recommendations. By working together to leverage a COVID-19 legacy, we can deliver immense benefits to those most at risk, our vital research and clinical community, and our society.

Matthew Gibbard
BSI Policy and Public Affairs Manager
Email: m.gibbard@immunology.org

Report recommendations

Lessons from measuring vaccine-induced immunogenicity in COVID-19

Immunogenicity research should be recognised as a central part of the UK’s pandemic preparedness plans.

Vaccines regulation and monitoring

Regulators should clarify the laboratory evidence needed to bring a vaccine to market and what industry can do to collect these data.
Decision-makers should clarify what post-marketing surveillance immunogenicity studies are required to inform the need for booster vaccines and prioritisation of at-risk groups.
An agreed toolbox of companion diagnostics should be defined to support vaccine development, licensing and adoption.

Validation and standardisation of assays

There should be a clear process for the development and monitoring of standardised, high-quality assays for immunogenicity that can be used as surrogates of vaccine protection.
Guidance should be provided to the scientific community on standardisation requirements for assays and the steps required for developing international reference standard reagents.

Mucosal immunity

We must prioritise research into the understanding and accurate measurement of mucosal immunity.
We need to develop methods for predicting how well a vaccine will confer sterilising mucosal immunity and prevent onward transmission of infection.
Regulators must clarify the regulatory requirements for vaccines designed to reduce transmission to stimulate research by industry into this area.

People with weakened immune systems

We are urgently calling for more research on which assays correlate with protection for people who are immunocompromised.
People who are immunocompromised should be included in licensing and post-marketing surveillance programmes for vaccines.
Vaccine development should consider achieving successful immunogenicity in people who are immunocompromised.

Point of care and at-home testing

A legacy of COVID-19 should be ensured through continued point of care and at-home testing for immunogenicity and recognise how this can be of use to post-marketing authorisation studies mandated by the MHRA to bridge the divide between immunogenicity studies and real-world data.
We must ensure that there is proper government and industry support for the UK diagnostics sector through boosting capacity, inward investment and skills.

Leadership and co-ordination

A UK vaccinology network based on pandemic models of working, with continued funding and strong leadership, should be established to devise and address key questions and challenges in immunogenicity.
We must ensure that routes for knowledge transfer in a pandemic situation are clearly delineated with a focus on knowledge generation.
Coordination within the UK’s antibody and vaccine development research community should be improved, and this should include mapping the UK’s academic innovation and capacity, as well as developing a virtual biobank of samples stored in UK laboratories.
There should be template agreements drawn up in advance between academic research institutions, government and industry on compensation for components used in assay development and for intellectual property arrangements.
There should be clear and transparent advice ahead of time from the Health and Safety Executive that allows UK researchers to provide their expertise in the event of another pandemic. This should be combined with establishment of a standardised and centralised portal for material transfer agreements.