On 29th April. LSTM hosted a unique convening of expertise on vaccination in honour of World Immunization Week 2020.
The first in a series of three virtual symposia, showcased the range of exciting research underway at LSTM and University of Liverpool and brought together global experts and high-level policy makers to discuss global research and pandemics in the context of emerging pandemics. The symposium also saw the UK government reaffirm its pledge, earlier that day, to fund Gavi £330 million a year for the next five years
Participants joining from around the globe posed some questions online to our speakers: Professor Julian Hiscox (University of Liverpool), Dr Rachel Tolhurst (LSTM) and Professor Daniela Ferreira (LSTM).
Here our respected speakers answer those questions that time restrictions prevented them from answering during the live symposium.
Research and Development
What are the implications of these accelerated vaccine development to individuals?
Julian: My opinion is that we have to be careful to balance the need for speed in people with the need for safety and animal studies. With a number of vaccines there is a risk of vaccine induced enhancement of viral infections. Licensure for a vaccine for SARS-CoV-2 (the strain of coronavirus that causes COVID-19) is likely to have to go through the FDA animal rule as it is probably not possible to vaccinate people and do a challenge study in humans. Human challenge trials are trials in which participants are intentionally challenged (whether or not they have been vaccinated) with an infectious disease organism
The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious/life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents, where human efficacy trials are not feasible or ethical.
I am also concerned that we might not be heeding the lessons from vaccines developed for animal coronavirus infections (where there has been 40 or so years of work) where multi-valiant/live attenuated vaccines give the best protection for the longest duration. Whilst I hope that the current vaccines work, I am not necessarily convinced that basing all our hopes on a vaccine solely around the spike glycoprotein in a rush to develop something will be the long-term solution.
Daniela: Even in accelerated programmes we have processes in place to ensure the safety of participants in these trials. Any potential risks must be highlighted to participants during informed consent, which must be obtained to take part in a trial. Regulators (such as FDA, MHRA and others) and Data Safety Monitoring Boards provide an oversight on the safety of the trial - ensuring that even when progressing from phase-I to II then III at a such a fast pace, all data is reviewed and considered as the trial progresses with clear stopping rules in case safety signals emerge.
- As part of a road map to accelerate vaccine development for COVID-19, WHO has now published a document with key criteria for ethical acceptability of COVID-19 human challenge studies.
- The Wellcome Trust has also put together a group of experts that consider the safety aspects, ethics, regulation, timelines and usefulness of such a human model. The view of many experts in the field is that at the moment, because we don’t have reliable treatment options for volunteers who might be challenged with SARS-CoV-2, we have to approach challenge studies extremely cautiously.
Do the panellists have comments on testing of vaccines in pregnancy?
Daniela: Most, if not all, early phase vaccine testing excludes pregnant women as well as those women who do not have adequate contraceptive measures and therefore are at high risk of becoming pregnant during the trial. This is because at the early stages of testing of a vaccine we do know not have much information about safety and potential effects on foetal development.
Can local government (I am cabinet member for public health and adult social care in Liverpool UK) help out in helping facilitate vaccine trials in vulnerable groups and locations (care homes)?
Daniela: I agree it is hugely important that we have a mechanism to facilitate this locally. Liverpool Health Partners which brings together University of Liverpool, LSTM and all the local NHS trusts facilitate that for clinical research in the hospital and community. I am aware there are over 90 care homes in Liverpool City Region and we need to do more to also coordinate research in this setting, and give its staff and residents the opportunity to also take part in these trials. I am also aware of coordination efforts to support interventions to address COVID-19 in care homes through the Strategic One Liverpool Partnership for COVID (STOP COVID) initiative and its links to Liverpool Health Partners.
In many parts of the world social distancing is a privilege that few can afford. I have heard some say “We either die at home of hunger or die outside of Covid”. What additional measures may be implemented specifically to benefit the Global South?
Rachel: It is clear that across multiple contexts in the Global South restrictions on movement are having devastating consequences for the livelihoods and coping strategies of many people, particularly those working in the informal sector dependent on daily earnings for basic necessities. It is widely agreed that in general the pandemic has magnified existing socio-economic inequalities and resulting vulnerabilities, pushing many people further into poverty and even destitution. This was described as ‘famine’ by a participant in rapid research in Dhaka, Bangladesh. In addition, it has exposed failures in governance and the accountability of the state for the right to health of all citizens, including those living and working in informal spaces. The responses of many governments to the risks of COVID-19 have failed to take into account the significant and predictable impact of restrictions on movement for those in the informal sector (often the majority of citizens).
I think it is difficult to develop a ‘one-size fits all’ approach, but social protection, including food distribution, is a necessary component of government responses. For example, our colleague Sumit Mazumdar has made the case for a Targeted Emergency Livelihood Insurance (TELI) implemented as a direct benefit transfer (DBT) in India. Critically the design of enhanced social protection schemes should involve representatives of affected people, including community- based organisations and other civil society organisations. This is important to ensure that the approach is informed by and jointly implemented by people with an in-depth understanding of and affected by the challenges of restrictions on movement and to promote respect for human rights and accountability throughout ‘relief efforts’. There is a danger that without the opportunity for enabling community ‘voice’, people living and working in urban informal spaces lose their sense of agency and become passive recipients of ‘handouts’ which are cast as charitable rather than fulfilling their rights to life.
Where does the accountability lies with inter-state migrants who are living in informal settlements, and going back to their hometowns. Whose stewardship model to follow in India when state governments have different models of managing COVID-19?
Rachel: The ARISE Hub focuses on urban informal spaces, but of course many people living and working in these spaces (including on the pavements) are migrant workers, whose acute vulnerability has been exposed and exacerbated by the pandemic. Many of us have seen pictures and heard stories of the huge numbers of migrants attempting to return to their homes across great distances with few resources and the suffering that this has caused. Again, this phenomenon has exposed the lack of consideration of the rights and vulnerabilities of this significant part of the population, who are integral to the functioning of cities, in the pandemic response. It has recently been argued that the pandemic has exposed the lack of a system to address such events, which has its roots in colonial legislation. This situation has required the government to use the Disaster Management Act (2005), which is not really fit for addressing the complexities of a pandemic, whilst different states have also issued over 2000 State directions. It has also been argued that: “The fragmented manner in which these legal provisions have been invoked shows a lack of clarity in how the Centre and States have interpreted their roles under the Constitution as it stands”. The important principle here, however, is that that in a time of crisis a humane governance model is required, and both the centre and the states are responsible for the welfare of the migrant workers. Collaboration is required between the Union, states, and lower levels of government, as well as with civil society and migrant workers themselves, to safeguard their rights.
In Bangladesh national immunization programme is hampered because of COVID-19. Do you think it imposing threat for vaccine preventable diseases outbreaks in near future?
Rachel: It is certainly a serious concern that immunization programmes have been disrupted, posing a risk of future outbreaks. We need measures to identify and vaccinate children who have missed doses during the COVID-19 pandemic. More broadly, there is potential for disruption of other core primary healthcare services, including maternal health services, sexual and reproductive health services, and disease control programmes such as TB and HIV services. We do know that in previous severe epidemics such as the Ebola epidemic in West Africa, health service utilisation declined significantly, with as yet unknown implications for future mortality, morbidity and mental distress. Efforts to protect immunisation and other core public health services, particularly for the poorest, most vulnerable and marginalised, will be of vital importance in the COVID-19 response.
The second symposium 'Global Health Research: towards ending preventable deaths: Equity, Access and Delivery’ is scheduled to be held on the 27th of May and the third towards the end of June. Do not miss out on the chance to register.