In January 2021, the strenuous process of mass vaccination is now in the early stages of action. Queen’s held an event welcoming several speakers to discuss the ongoing work being done in the battle against COVID-19. The “Beyond Coronavirus” event featured a keynote address from Professor Sheena McCormack, Clinical Project Lead for the COVAC trials, with a response from Dr Mark Flear, Reader in Law, Queen’s University Belfast, followed by a discussion chaired by Ann Watt, Director of Pivotal Public Policy Forum.

All images presented in this piece are courtesy of presentations made by speakers during the event.

Professor Ian Greer, Vice-Chancellor of Queen’s University Belfast introduced the event and made note of the admirable resilience displayed by staff, researchers and students within higher education during the pandemic. He pointed out the vital part institutions across the world currently play in tackling such a huge challenge and how the development of the Oxford AstraZeneca vaccine bears witness to the extraordinary contributions made by universities in conjunction with other industries.

Keynote Address

“An extraordinary global effort”

Professor Sheena McCormack is a Clinical Epidemiologist who has worked on HIV vaccine, microbicide and PrEP trials since 1994. In addition to several other trials across the globe, she is currently involved with the COVID-19 vaccine trials.

Professor McCormack was optimistic about the rollout within in the UK, but addressed concerns of the public in relation to the emergency MHRA authorisation of COVID vaccines. In response to these concerns, Professor McCormack presented data demonstrating the vast amount of work that has already been put into developing candidate vaccinations across the world (172 vaccines already in pre-clinical development).

A host of NGOs, not-for-profit organisations and legal entities are standing behind the development of any UK vaccine. One such organisation, The Brighton Collective, is particularly committed to ensuring the safety of the public, aim to build trust in the safety of vaccines through rigorous science. Partnered with CEPI (Coalition for Epidemic Preparedness Innovations), the collective has established a number of safety controls that any vaccines used in the UK must satisfy, including assessment from independent committees, as well as an expert analysis of data across all platforms.

So, what is the plan for vaccinations in the UK? Professor McCormack identifies three main objectives;

1. Securing access: The UK Vaccine Task Force aims to secure access to 357 million doses of vaccines. This incorporates 100 million doses of the Oxford AstraZeneca vaccine, 40 million of the BioNTech/Pfizer vaccine, and 7 million Moderna vaccines.
2. Making provision for international distribution.
3. Establishing a long-term strategy for the future.

“Control is the Goal”

Professor McCormack is doubtful that the Covid-19 virus can be completely eradicated in the future, yet she is optimistic about the strategies being put into place worldwide for the future. In order to be better prepared for the next possible outbreak, we must be more secure in relevant supply chains, which would in turn enable the scaling up of rapid testing. The shortage of beds and manpower within the NHS must be remedied as much as possible – Professor McCormack made a point to express her gratitude to the NHS staff who are currently coping with the pandemic. The manufacturing capacity within the UK must also be improved upon in order to smoothly administer vaccines throughout the country. The continued regrowth of the UK’s economy as businesses and industry reopen will stimulate these improvements.

Professor McCormack acknowledged the work and effort made by participants in all vaccine trials, research teams, not-for-profit supporting infrastructure as well as private and government funders. In return, Queen’s University Belfast expresses great gratitude to Professor McCormack, not only for her keynote address, but the invaluable work she has done and continues to do in vaccine trials.

Regulatory and Legal Framework that Underpins the Covid-19 Vaccine

Dr Mark Flear is Reader in Law at Queen's University Belfast. A key strand of Dr Flear's work looks at the law on clinical trials, including the licensing pathways for vaccines and treatments for rare and emerging diseases, particularly against the background of Brexit. This work has been widely cited, including by the European Group on Ethics in Science and New Technologies of the European Commission.

In his presentation, Dr Flear explained that under UK law, all vaccines are “medicinal products”. As such, any medicinal products must fulfil requirements relating to safety and effectiveness (and quality) in order to gain MHRA licensing. UK licensing for the COVID-19 vaccines were granted under emergency processes, but the quick licensing does not negate the safety of these products: safety and effectiveness are still ensured.

Taking a closer look at the standard phases for vaccination authorisation, Dr Flear turned to the approach taken with COVID-19 vaccines in the UK (refer to image above). The reworking of the standard format for trials to accommodate emergency procedures means that the vaccines currently stand somewhere between Phase III and Phase IV. The continuing focus throughout the trials is on safety and efficacy. Furthermore, Dr Flear explained that all vaccine trials (including the emergency COVID trials) are subject to several laws that reflect both international ethics codes and human rights, such as the Nuremberg Code.

Roll Out

After rigorous trials and largely successful trial results, the roll out of vaccines within the UK has begun. In relation to possible implications consequent to Brexit, Dr Flear states that changes to the movement of vaccines between the EU and UK, as well as between GB and NI will not present an issue of supply availability. Supply is maintained through batch testing – this can be carried out within the EEA and UK, meaning there are less possible barriers to smooth delivery of safe vaccines.

An interesting point raised by Dr Flear is that the UK government have decided to indemnify vaccine producers against liability for harms against patients. Whilst this may initially appear to be a cause for concern for many, it must be emphasised that this decision does not arise anew with Coronavirus. The UK government has taken this same approach with vaccines against HPV, Meningitis and Swine Flu.

In closing, Dr Flear again affirmed that safety and effectiveness are the paramount concerns of all law relating to vaccines - vaccines can only be licensed if clinical trials data reflects safe and effective results. The UK is far from the end of the pandemic’s grasp over us, but there is a definitive light beginning to appear at the end of the tunnel.

Q&A Session

Q&A Session

Both speakers addressed several questions from audience members. The forum for the session was kindly hosted by Ann Watt. Ann is Director of Pivotal, an independent public policy thinktank within Northern Ireland. She is also a former senior civil servant, with 20 years’ experience in Belfast and London. Most recently, Ann was the Head of the Electoral Commission in Northern Ireland, working to ensure fairness and transparency in elections and political finances.

Q: Are there any concerns for vaccinating immunocompromised individuals?

An existing concern is that immunocompromised patients may not make as good responses to the vaccine. Professor McCormack answered that she is eagerly looking forward to discovering what the threshold of required immunity is – only time shall tell. She does not have concerns with any of the currently licensed vaccines being administered to immunocompromised people in terms of safety, and notes that the only factor that would require monitoring would be the ongoing effectiveness of the vaccine for such individuals.

Q: Was scientific evidence presented to support the government's policy of ‘mixing and matching’ different vaccines, and extending timescales between doses?

An existing concern is that immunocompromised patients may not make as good responses to the vaccine. Professor McCormack answered that she is eagerly looking forward to discovering what the threshold of required immunity is – only time shall tell. She does not have concerns with any of the currently licensed vaccines being administered to immunocompromised people in terms of safety, and notes that the only factor that would require monitoring would be the ongoing effectiveness of the vaccine for such individuals.

The issue of timescale between doses is being looked at currently in the preclinical space in an ongoing capacity. Professor McCormack has no undue concerns regarding the government’s choice to administer more than one vaccine within the UK. All along, a need for a boosting strategy has been anticipated by scientists, and the same approach has been taken in combatting the common flu, with a different vaccine being rolled out each year.

Q: Is there a case for a mandatory vaccine policy in the UK?

Dr Flear responded that he does not believe mandatory vaccination is justified in the context of the COVID-19 pandemic. Certainly, there is a need to reach a certain level of immunity within the population to ensure safety within the UK, and with the general public willingness to receive vaccination against the virus, it’s very likely that ‘herd immunity’ will be achieved without the mandate of a vaccination for all.

Professor McCormack agreed, and was emphatic of the ethical importance of consent in regards to vaccination. In terms of protecting the public, enough people are willing to be vaccinated, that an individual’s right to refuse the vaccine for any reason can still be protected without endangering the wider effort to achieve herd immunity.

Dr Mark Flear

School of Law

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Acknowledgements

This article purely serves as a short overview of the findings provided by both speakers at the event, and all readers interested in learning more about Professor McCormack’s and Dr Flear’s presentations are encouraged to watch the event in full using the link provided at the top of this piece. The university extends its warmest thanks and gratitude to Professor McCormack, Dr Flear and Ann Watt for their time and expertise they were able to share with us during this event. Thanks also to Professor Elborn of Queen’s University Belfast for his conclusion of the event, and his emphasis on a social contract we now face in combatting the COVID-19 virus in the future.

Future events, concerning not only the Coronavirus pandemic but issues of social policy, politics and wider challenges, shall be taking place within the university over the next number of months. All interested parties can stay updated on all upcoming events by following @QUBEngagement on Twitter.