Before COVID-19, it took an average of about ten years to develop a completely new vaccine, with the process never before achieved in less than five years. Given scientific research progresses so slowly under normal circumstances, how have the COVID-19 vaccines been developed so quickly and what does this mean for the future of vaccine R&D?
Amid a pandemic, time is a luxury the world cannot afford. And whilst a lot is still left to play out, the COVID-19 pandemic will be an example of what science can achieve when the world’s resources and time are focused on achieving one thing.
Timing is everything…
The pressure to develop a vaccine against the COVID-19 virus, SARS-CoV-2, has coincided with an unprecedented explosion of fundamental science and innovation in areas such as genomics and molecular biology, that is supporting a new era in vaccine development.
Advances in genomic sequencing meant that researchers were able to uncover the RNA sequence of SARS-CoV-2 in January 2020 – roughly ten days after the first reported cases in China. Furthermore, much of the technology that underpins modern vaccine progress, such as the development of the molecular components of vaccines and manufacturing facilities with capacity to develop vaccines at scale, we didn’t have twenty years ago.
In addition to the concurrence with a scientific awakening, are our learnings from pandemics and epidemics experienced before. Over the past fifteen to twenty years, the scientific community has had to respond urgently to solve major public health crises. In 2009, the development of an H1N1 vaccine utilised existing flu vaccine technology. This showed the potential of “platform technologies” which involve slotting genetic material from a novel pathogen or virus into a tried and tested existing machinery. The use of platform vaccine technologies means that multiple vaccines against different diseases can be produced from a single proven method, typically meaning they can be developed rapidly and with a greater understanding of the safety profile from the offset.
Since then, companies and cross-sector collaborations have been investing significantly in such approaches. The Coalition for Epidemic Preparedness Innovation (CEPI), for example, has been supporting the development of vaccines against five emerging pathogens on the World Health Organization priority list, since its genesis in 2017. CEPI also supports the development of platform technologies to prepare for “Disease X” – any newly emerging and potentially epidemic disease, such as COVID-19.
Both the Oxford/AstraZeneca and Pfizer/BioNTech vaccines were developed using platform technologies which didn’t exist 20 years ago, allowing these vaccines to be developed much faster. The use of this technology should also be reassuring, should the current vaccines prove to be less effective against new COVID-19 variants, as these can be adapted rather than needing to start the development process from scratch.
…And money helps
Vaccine R&D is hugely costly.
Very soon into its life, the pandemic became a major political topic and the cost of not addressing it began to far outweigh the cost of finding a solution. Public and private resources have been poured into COVID-19 vaccine development. Not only does this help to mitigate the initial cost burden associated with R&D, it also reduces some of the usual financial risk facing pharmaceutical companies. What’s more is with the level of demand and the guaranteed market, with governments pre-buying vaccines, companies were able to take greater risks with early-stage research. In normal circumstances, companies will carefully consider the demand and market and take strategic decisions at each step in the scientific process to consider the best commercial route. Collaborative funding pushed many of the usual hurdles aside.
In the United States, Operation Warp Speed (OWS) is working with multiple organisations, to develop, manufacture and distribute 300 million vaccine doses in 2021. The European Commission and the UK Government Vaccine Taskforce have also been significant contributors to a wide variety of vaccine projects.
Through an exceptional effort, clinical trial phases which are normally carried out in sequence, were overlapped and also conducted in parallel with vaccine manufacturing. Advances in data-recording technology and social media coupled with the wide-ranging inclusion criteria meant that recruiting trial participants was relatively straightforward, as was the regulatory process where organisations, such as the European Medicines Agency (EMA) introduced “rolling reviews”, to monitor data as and when it was produced.
Quoted in a recent article on the COVID symptom study app, Professor Peter Openshaw from Imperial College London said, “There’s been so much money poured into the process that it’s like the milk float has a police escort and all the traffic lights are on green. It doesn’t mean to say that the route that has been taken is any different.”
The power of partnerships…
Clearly, rapid vaccine R&D requires extraordinary cross-industry and sector collaboration. The pharmaceutical industry should reflect on the events of this past year, and consider how to shape its partnerships for success in the future. The pandemic should testify to the power of close dialogue with regulators and new models of peer-to-peer collaboration.
Vaccines have never before been so centre stage. The public have seen what science can achieve when the world’s resources and time are focused on achieving one thing. This raises the question of whether we will ever be able to return to ten year timeframes for developing new vaccines. Ultimately, the speed of such scientific success is not the result of one magic bullet, but the culmination of a number of factors that have all played a part. Companies will now be considering and experimenting with ways to accelerate R&D and the role of public interest. With increased public scrutiny and reinvigorated political will for progressing science, there will be a role for a strategic and connected approach across communications, policy, and R&D to reflect on how much has changed, and on what new factors should shape decisions and actions in the years ahead.