What can we learn from the COVID-19 drug and vaccine development?

The pandemic saw a rapid development of new drugs and vaccines but also highlighted the need for globally coordinated research, writes Dr Bastian Rake, School of Business.

The COVID-19 pandemic has powerfully demonstrated that there is a need for the rapid development of new drugs and vaccines. But which development activities have been undertaken in the early phase of the pandemic?

A recent study I have undertaken with Dr Marvin Hanisch (University of Groningen) analysed how researchers in firms, universities, hospitals, and other organisations responded to the COVID-19 pandemic.

The analysis of clinical trials testing the safety and efficacy of new drugs, new vaccines, or new medical devices, that were initiated between December 2019 and July 2020 revealed intriguing and surprising results.

The study shows that clinical researchers around the globe reacted rather rapidly to the pandemic. The number of COVID-19 related clinical trials increased almost exponentially in spring 2020. However, the increasing number of clinical trials does not imply that these research efforts focus exclusively on finding safe and effective treatments or vaccines against COVID-19.

Instead, the study shows that even at the very start of the pandemic no more than around one‐third of the clinical trials investigated drugs or vaccines that would help to cure the disease or prevent infection. Most trials initiated in the early phase of the pandemic focus on other issues such as the physical and mental health problems associated with the disease itself or the associated public health measures as well as on identifying and monitoring the symptoms of the disease.

It was particularly surprising that only around 2% of the clinical trials in the early phase of the pandemic focused on vaccine development.

Those trials that focused on testing drugs as a treatment against COVID-19 were predominantly evaluating the effectiveness of already existing medications. This so-called re-purposing has the advantage that it allows for rapid responses. The downside of this approach is that the associated research is like searching a needle in the haystack.

Therefore, a very broad search strategy that includes as many existing medications as possible would increase the chances of finding a safe and effective treatment. However, the authors find that many trials test the same (combination of) drugs. What is concerning is that a considerable number of trials started to test medications, such as the malaria medication hydroxychloroquine, although several studies and regulatory authorities had already raised concerns regarding the medications’ efficacy.

This observation raises the question of whether the current use of resources maximises the chances of finding one or several effective treatments. In addition, the study by Rake and Hanisch indicates that inefficiencies in the use of resources and research investments exist.

The observed duplication of research efforts may be caused by a lack of coordination and information exchange between researchers. The lack of (international) collaboration and knowledge exchange leads to a situation in which researchers from different locations try to reinvent the wheel multiple times. The study supports this view as the analysis indicates that only a small minority of COVID-19 related clinical trials is jointly initiated and financed by organisations from different countries.

Another result is that biotechnology and pharmaceutical companies – particularly the world’s 50 largest companies – have initiated or financed only a small fraction of COVID-19 related trials in the early phase of the pandemic. This is surprising given the high global demand and the huge investments large biotechnology and pharmaceutical companies generally make in developing new medications. In addition, large biotechnology and pharmaceutical companies have large portfolios of approved medications and of medications under development that may be repurposed to treat COVID-19.

Consequently, the results raise questions of whether firms have appropriate incentives to engage in re-purposing and to shift their resources from alternative options to the search for treatment options among their existing product portfolios.

The study results have important policy implications. Firstly, the results call for prioritising international coordination and information exchange to reduce the inefficient use of resources and to increase the chances of finding one or several effective treatments against COVID-19. Hence, governments need to carefully review whether their own responses to the pandemic promoted locally isolated instead of globally coordinated research.

Secondly, policy makers need to review the incentives for searching new applications for already existing medications. Currently, biotechnology and pharmaceutical companies have little incentive to explore whether their existing products could be used as treatments against additional diseases such as COVID-19.

Firms face the challenge that they still would need to make substantial investments in this type of research but have quite limited opportunities for protecting the results through patents or market exclusivity rights. It is unclear whether their investments in searching new applications could be regained.

Hence, most firms seem to be reluctant to engage in repurposing. Reviewing and revising the existing incentives for repurposing is important as repurposing of existing medications can support the development of treatment options for diseases with unmet therapeutic needs such as diseases that affect a rather small number of individuals. Policy makers could potentially realize benefits that extend beyond the current COVID-19 pandemic and improve the health of many individuals across the globe.