Have you ever watched a Formula One pit stop and tyre change? Though no fan of car racing, I find the 2-second pit stops breathtaking. In 1937 the pitstop record was 33 seconds – impossibly slow by today’s standards. Continual improvements in technology and the coordination of the process have seen the near 20-fold reduction in time. Vaccine development has seen similar changes in the process: previously vaccine development had usually taken decades. But the improved processes and rapid funding access reduced this to an amazing nine month development process in 2020 for the first Covid vaccines.
This was not a result of cutting corners, or reduced stringency for approvals, or operation WARPspeed, but a result of preparations and planning in the years before the pandemic. A key stimulus for this preparation was the failure to complete vaccine development processes in the Ebola and SARS epidemic.
That “failure” helped trigger the establishment of the Coalition for Epidemic Preparedness (CEPI). The aim of CEPI was to provide global coordination and emergency funding for the vaccine development and testing of several parallel vaccines candidates. Given many efforts fail, it was too risk to rely on any one vaccine.
A major lesson has been the better management of vaccine development processes (insert figure here and reference to the Jenner Institute video). To simplify the phases of a vaccine development process are:
Development: Work in the laboratory to development a candidate vaccine, then
Phase 1 – test the vaccine in a small number of people to check it is safe
Phase 2 – do safety tests in more people, plus look for signs the vaccine is producing the required immune response
Phase 3 – the big trial, involving thousands of people, to check whether it actually protects people.
A major problem has been the time between these phases, and the solution is to remove that dead time (Figure). In an interview with the BBC Dr Mark Totness said the idea that it took 10 years to trial the vaccine was misleading saying “most of the time it’s a lot of nothing“. By ‘nothing’ Totness meant the dead time of writing grant applications, having them assessed and rejected, re-writing and submitting them, getting approval to do the trial, negotiating with manufacturers, and trying to recruit enough people to take part in a trial. The gaps between are usually much greater than the work time.
Several vaccines did manage to complete all the phases and evaluation before the end of 2022 with a close race between them. One example was the Oxford vaccine (subsequently known as the Astra-Zeneca as they picked up the manufacturing and distribution). Within days of the posting of the genome sequence of the SARS-CoV-2 virus, Professor Sarah Gilbert in Oxford commenced work to develop a possible vaccine. Within months, her colleagues on Oxford were starting the trial, which included 30,000 volunteers in the phase 3 trial. Like the Formula One pit stop, no corners were cut, but the process was streamlined and better coordinated to achieve its amazing speed.
The result of course has been a vast reduction in the impact or potential impact of the COVID-19 pandemic: an estimated 20 million lives saved so far. Of course that’s the tip of the iceberg in terms of prevented hospitalisations prevented cases and prevented long-term morbidity and the economic consequences. The size small investment by CEPI and others in preparation for this pandemic has been a true blessing to mankind, with most of the players getting far less attention than that for the noted anti-vaxxers who worked to undermine their fantastic efforts.
Healthy Evidence 