Special Populations in PHEs (I): Paediatrics

This webinar was part of our series on Preparedness Planning for Public Health Emergencies.

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Meeting Report

Professor Mariana Kruger– started the discussions with comment that paediatric trials are essential in child healthcare and of the current clinical hold on trials in the context of COVID-19 has had major impact. Enrolling new patients has mainly stopped to reduce the risk of resources being diverted away from treating Covid-19 patients.   For those patients that are already enrolled in the studies some creative solutions had to be found for limiting hospital attendance.  It was emphasized that there is a need to advocate in order to ensure any impact is kept minimal, including access to medicines that has been impacted. Professor Kruger explained that most medicines for South Africa are supplied via China and therefore early on in the pandemic, issues with supply has had major impact on healthcare. Many children have missed their routine vaccinations and many drugs are out of stock and this has needed action to address. Professor Kruger concluded that the pandemic has impacted children in South Africa and held back research in other important areas, providing a  clear message that important clinical trials need to continue wherever possible. For some children in South Africa attending clinics in relation to clinical trials allows access to food for children who wold normally be dependent on supplies from schools. 

Professor Sidnei Epelman– stated that the number of new cases of Covid-19 decreased initially but now is beginning to rise again and inevitably the poorer areas are hardest hit due to multi-generation occupancy of inadequate housing. Health care is provided mostly by the public health system (80%) and 15-20% is privately provided. So far the incidence of Covid-19 infection, requiring treatment by Professor Epelman, in children has been limited to 7 cases. Six of these have done well and only one, who was diagnosed late in another centre, did not survive. 

Professor Barbara Bierer- mentioned that in Boston they were hit by the early first wave of Covid-19 virus. They have learnt that one should not underestimate the impact of pandemic on children. Children are serious reservoir for the virus and the social impact on their well-being and health should not be ignored. There has been a steady increase in number of trials conducted in children however, these are often small, under-powered studies in the US, perhaps not that informative. Professor Bierer made a plea for maintaining high ethical standards and not compromising scientific integrity in rushing to trial with unproven treatments and a lack of coordination of research in the US. There is a systematic lack of communication and it was stated that we should all be learning from each other and not working in isolation. ProfessorBierer also highlighted the structural problems within the  social fabric of the US, with many living in one room and unable to isolate, often with parents who are care workers. Certain minority groups are disproportionately affected. There has been huge disruption in clinical care and many trials including paediatric oncology trials have had to close down. Professor Bierer went on to describe  the huge differences they have seen in the way in which trials are run with remote testing and virtual ‘visits’ increasing and concluded by emphasising the need to ensure we advocate for children at every stage of the pandemic and continue to push for appropriate formulations and treatments for children.  

Questions to the Panel 

The panel was asked who they thought was in the best position to co-ordinate international studies: organisations such as the WHO or the international academic societies. 

Professor Mark Turner highlighted that the WHO paediatric community is currently talking about a number of protocols for observational studies. They do have the capability to push policymakers to make decisions and help communities work together, having learned from the past.  

Professor Sidnei Epelman– stated that clinical trials in some countries were the only way to access drugs 

Professor Mariana Kruger- mentioned that it is crucial in HIV/Aids trials that the global research network should be utilised more. The infrastructure is already there as historically created by e.g. NIH. 

The panel were then asked when should we beginning including children in the vaccine studies?  

Professor Barbara Bierer – Suggested that it was appropriate to start with normal children first before moving to the most vulnerable population with co-morbidities. It was important to avoid missing the opportunity of collecting as much data as possible. 

Professor Mariana Kruger – Suggested that her preference was to go to the at-risk adults first: those older patients with co-morbidity who were most at risk from Covid-19 infection.  

A further question to the panel was whether the nature of clinical trials migh change in the future with more hybrid and virtual trials? 

Professor Barbara Bierer– agreed that although there were some concerns about privacy and confidentiality if these were overcome then it would bea good way forwards.  

Professor Mariana Kruger- thought that employing more telemdicine  will have a major impact on research in future and major cost savings for families and is the real future for us.  

Professor Sidnei Epelman– added that this was one positive thing to come out of the pandemic and driving this approach to clinical trials would be very worthwhile. 

Next question to the panel related to barriers to accessing existing networks and infrastructures in other therapeutic areas (obstetrics, HIV, TB) for unexpected and acute problems like COVID-19, especially because the reasons for establishing those structures might remain important? 

Professor Mariana Kruger- – suggested that the situation had improved a lot because of technology and use of virtual meeting, more advantages than barriers now because of Covid-19 

A global registry of children with COVID and paediatric cancers is being created.  All vaccines needed attention and there were concerns about security of supply of vaccines such as BCG in South Africa 

Professor Barbara Bierer referred to one consequence of repurposing drugs such as hydroxychloroquine was that patients requiring these drugs for the licensed indication were aometimes missing out as a result. Trust was also very important and ther is a real danger that trust in the long term is undermined by poor information, disinformation and overpromising. 

On the topic of transmission between school children providing a continued reservoir of infection, Professor Kruger felt that it was more likely that parents were infecting children rather than the reverse. 

In a more general discussion about vaccine development Professor Epelman was asked about vaccine researchers coming to Brazil, with its increasing rate of infection, to conduct trials. In response he was happy to welcome this initiative and in terms of who should have first access to the vaccine if the studies should prove successful suggested that this should be those in greatest need. Of course, the ethical principle of providing access to medicines to the population involved as trial subjects was restated. 

Leonardo de Castro from the Phillipines mentioned that he was concerned about acceptance of any new vaccine developed as he was already seeing decreased uptake of those vaccines already available for other diseases. Again, a matter of trust.