From COVID-19 research to vaccine application: why might it take 17 months not 17 years and what are the wider lessons?

Abstract

It is often said that it takes 17 years to move medical research from bench to bedside. In a coronavirus disease (COVID-19) world, such time-lags feel intolerable. In these extraordinary circumstances could years be made into months? If so, could those lessons be used to accelerate medical research when the crisis eases? To measure time-lags in health and biomedical research as well as to identify ways of reducing them, we developed and published (in 2015) a matrix consisting of overlapping tracks (or stages/phases) in the translation from discovery research to developed products, policies and practice. The matrix aids analysis by highlighting the time and actions required to develop research (and its translation) both (1) along each track and (2) from one track to another, e.g. from the discovery track to the research-in-humans track. We noted four main approaches to reducing time-lags, namely increasing resources, working in parallel, starting or working at risk, and improving processes. Examining these approaches alongside the matrix helps interpret the enormous global effort to develop a vaccine for the 2019 novel coronavirus SARS-CoV-2, the causative agent of COVID-19. Rapid progress in the discovery/basic and human research tracks is being made through a combination of large-scale funding, work being conducted in parallel (between different teams globally and through working in overlapping tracks), working at greater (but proportionate) risk to safety than usual, and adopting various new processes. The overlapping work of some of the teams involves continuing animal research whilst entering vaccine candidates into Phase I trials alongside planning their Phase II trials. The additional funding available helps to reduce some of the usual financial risks in moving so quickly. Going forward through the increasingly large human trials for safety, dosage and efficacy, it will be vital to overlap work in parallel in the often challenging public policy and clinical tracks. Thus, regulatory and reimbursement bodies are beginning and preparing rapid action to pull vaccines proving to be safe and effective through to extraordinarily rapid application to the general population. Monitoring the development of a COVID-19 vaccine using the matrix (modified as necessary) could help identify which of the approaches speeding development and deployment could be usefully applied more widely in the future.

Social Distancing Intentions to Reduce the Spread of COVID-19: The Extended Theory of Planned Behavior

“…Despite efforts to develop an effective treatment for COVID-19 and a vaccine against the virus, currently there is nothing yet available that has been shown to be effective. Public o cials in the United States have suggested that a vaccine against Sars-CoV-2 will likely be available in 12 to 18 months [2]; [3].…”

Transforming the practice of medicine through team science

“…Indeed, the simple concept of institutional (private and public) prioritisation of research projects is playing out before our eyes during the COVID-19 pandemic. As Hanney et al describe in follow-up to their previous work, the attention and prioritisation provided at every level for COVID-19 vaccine development will most likely lead to health benefits in a small fraction of the 10 years usually experienced for vaccines [19]. TtP at a local institutional level and COVID-19 at a worldwide level offer strong evidence for greatly improved time to application when priorities are aligned and resources are mobilised.…”

How to strengthen a health research system: WHO’s review, whose literature and who is providing leadership?

“…The importance of partnerships and collaboration in focusing research efforts in an extreme crisis, with a leadership role for the WHO, has been seen in the race to find treatments for COVID-19 and vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the COVID-19 disease [89]. In many NHRSs across the globe, including in the Philippines, scientists are coming together to participate in WHO's Solidarity Trial, which will test the safety and effectiveness of various possible therapies for treating COVID-19 [90].…”

“…A key issue going forward is how such cooperation can be built on in strengthening NHRSs into the future. For now, it is recommended that a prospective study be conducted to analyse all that is being done in different NHRSs to speed up research during the pandemic, with a view to taking lessons about cooperation, partnerships and other matters into strengthening NHRSs in the future [89].…”