Supplementary written evidence submitted by Moderna Biotech UK Limited (ADY0612)
Moderna is a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines. In the 12 years since the company was founded, Moderna has developed the industry’s leading mRNA platform that builds on continuous advances in basic and applied mRNA science, delivery, technology and manufacturing. Our mission is to improve patients’ lives by creating a new generation of medicines based on messenger RNA (mRNA) technology. This would pave the way for clinical development of therapeutics and vaccines for infectious diseases, immuno-oncology and rare diseases.
During the oral evidence session on 18 April, 2023, Stuart Carroll (Director of Market Access and Policy Affairs) gave evidence on a number of topics of interest to the Committee. This included: the UK’s clinical trials landscape, health inequalities, falling vaccination rates, and the UK as a science superpower.
Moderna announced a 10-year partnership with the UK Government in December 2022 to deliver the Moderna Innovation and Technology Centre (MITC). The MITC will be a vaccine research, development and manufacturing centre in Harwell, Oxfordshire, and it will be the first of its kind in the UK. The MITC will create more than 150 highly skilled jobs, as well as new training and education opportunities. Crucially, the MITC will onshore vaccine production with the centre able to produce up to 250 million vaccines a year, providing the UK with a domestic supply of COVID-19 vaccines as well as potential vaccines developed for other respiratory infections.
Moderna is positive about its presence in the UK, as demonstrated through the significant investment into the MITC, and we are proud to support Government ambitions to cement the UK’s position as a science superpower. As our partnership with the Government continues, Moderna is committed to working with politicians, experts, and officials across the UK to minimise barriers to vital healthcare research and development to unlock patient benefits, particularly around the prevention of ill-health. Vaccines have a key role to play in this, and there are a number of recommendations that Moderna would like the Committee to consider, in order to ensure the UK is in the best possible position to take a preventative approach to health and care.
Clinical Trials
Clinical trials play a central role in the development and approval of new medicines, including vaccines and therapeutics. Vaccines are particularly key to preventative healthcare, and it is crucial that our clinical trials system is quick, efficient, and focuses on priority products.
There is a huge opportunity to make the UK one of the best countries in the world to conduct clinical trials. In order to take advantage of this, the Government must rapidly address a number of issues in the existing system. There are three key areas where Moderna sees the need for reform. These are:
○ Trial start-up: the Government must tackle unnecessary delays and barriers to trial start-up, including lack of capacity, capability, and resourcing at the MHRA; simplifying the patchwork of stakeholders involved in the process; embedding a prioritisation framework; and standardising application processes and timelines throughout the NHS.
○ Strategy and collaboration: the Government should work with the NHS, industry, and other government agencies to clarify an overarching strategy for clinical trials, including developing a national vaccine strategy; introducing a procurement panel to the JCVI; expanding research capacity in the UK beyond hospitals; and creating a dedicated R&D office in each Integrated Care System across England.
○ Innovation and diversity: the Government must ensure a strong, clear role for industry in the shaping of MHRA guidance around diversity in clinical trials. Diversity is crucial in clinical trials, as it proves to all patient groups that a product is safe and effective for them, and therefore plays a significant role in increasing vaccine uptake. There is also significant work to do to unlock the potential of digital and data to innovate clinical trial delivery, and investing in digital and data will further support Government ambitions to be recognised as a tech superpower by 2030.
Implementing the Lord O’Shaughnessy review with focus, speed and purpose will be essential. Ensuring there is a system of accountability and performance metric for implementation will be vital.
Personalised Therapeutics
In order to support the shift to increasingly personalised therapeutics which will be central to future healthcare, it is vital that we understand the regulatory requirements that will be needed to enable swift and safe approvals for such products. This is an exciting challenge to have, and Government and industry must be proactive to ensure we are equipped to approve and distribute personalised therapeutics when they come through the pipeline in the future.
Moderna is currently working with MSD to jointly develop and commercialise Individualised Neoantigen Therapies (INTs). This collaboration reported very positive Phase II clinical trial results in December 2022. In light of these positive results, we plan to undertake a pivotal phase III clinical trial as early as this summer.
We have ambitions to continue our collaboration with MSD and expand our INT trials into a wider oncological platform, and other tumour types. This could result in a significant opportunity to deliver a host of INT candidates in the UK, building on Moderna’s successful partnership with the UK Government to deliver MITC. However, in order to achieve this, the UK’s regulatory and approvals process must be reformed to enable increasingly personalised medicines such as INTs to come to market at pace. For many patients battling cancer, time is precious, and that is why we cannot allow unnecessary delays to the approvals of vital medicine such as this.
Public Health Reform
In order to support a shift to a preventative model of health and care, it is crucial that our public health infrastructure supports innovation and resilience. The Committee should focus on lessons learnt from the pandemic, notably that mission-based, purpose-based government and public health bodies work. We should therefore rethink public health policy to ensure the system is equipped to pre-empt issues, rather than constantly respond to crises.
Moderna believes this can be achieved through a series of reforms to public health bodies, including:
○ UKHSA: At present, UKHSA’s remit is far too broad. The Government should consider narrowing the remit of the body to focus on its original intent - to be a world-leading agency that helps the UK prepare for, prevent, and respond to threats to health. In order to achieve this, UKHSA should have a strong relationship with the newly created Department for Science, Innovation and Technology, and more funding should be allocated to the body to embed reforms, level up technical capability, and drive strategy.
○ MHRA: The MHRA is a world-leading regulator, but without urgent reform and Government attention, it risks falling behind its international counterparts. In order to retain its world-leading position, the MHRA must: tackle the backlog of approvals, identify areas of strategic priority, go further on international collaboration, invest in recruiting and retaining high quality staff, and consider introducing manufacturing dossiers to streamline administrative processes.
○ JCVI: The JCVI played a central role during the pandemic, but as the risk of COVID-19 decreases, the body should now focus its efforts on pre-empting future public health issues rather than responding to crises. To achieve this, the Government should invest in an enhanced secretariat for the body, and it should review the JCVI’s sub-committees to ensure the body has a strategic focus that aligns with public health priorities.
○ Procurement: As the UK seeks to ramp up its clinical capability, it is key that the Government looks at ways to streamline procurement processes to focus on speed and efficiency. This could be achieved by: embedding a prioritisation framework through the regulatory process and working with industry to identify said priorities, introducing a Standardised Framework for clinical trial start-up submissions, and introducing a procurement panel to the JCVI.
Tackling Vaccine Hesitancy
To increase vaccine uptake across the population, it is absolutely crucial that diversity is at the core of clinical trials, with industry playing a role in establishing a clinical trial diversity criteria. The average UK clinical trial currently has an average of 6% patients from ethnic minorities - this simply is not good enough if we expect the whole population to receive a vaccine.
In order to instil confidence in the public - who are increasingly less trusting of Government and institutions
- it is vital that clinical trials are truly representative of the population to demonstrate that a vaccine has the
right efficacy and safety profile for each type of person that will receive it. Diseases do not discriminate, and they can impact all people differently. We can only advance science and advance clinical outcomes for all patients if they are represented in clinical trials.
Another issue is access to healthcare - declining rates of vaccination could be attributed to difficulty in travelling to the nearest health service to receive a jab. Throughout the pandemic, we were able to mobilise a wider range of medical professionals to administer vaccinations, such as pharmacists, who are more present in communities. This enhanced level of access makes it not only easier for an individual to access vital healthcare such as a vaccination, but it allows patients to build trust and develop a relationship with their local medical professional. We should be considering other types of medical professionals who could offer such services in order to improve access to health and care.
The Government and MHRA should also look at reforming the Yellow Card reporting system to ensure that data on vaccines is as transparent and accessible to the general public as possible. At the moment, we have a system that can be easily misinterpreted, which results in the spread of misinformation and consequently fear or hesitancy about vaccines. The system should focus on the publication of clear, concise facts relating to vaccines in order to build trust amongst the public who have been exposed to significant levels of misinformation, particularly around COVID-19.
Moderna would welcome a joint plan being developed and put forward, outlining how the UK plans to address low vaccine uptake in minority communities, and working with industry to develop tangible proposals to build trust and increase uptake.
May 2023