By Karen Taylor, Director, and Maria João Cruz, Research Analyst, Centre for Health Solutions
The London Marathon was meant to take place on Sunday, April 26, but was postponed until October due to the COVID-19 pandemic. This was a great disappointment to the 40,000 people intending to take part, as well as the thousands of charities that the runners were raising money for. In its place social media launched a 2.6 challenge campaign urging the public to run, walk, cycle or skip over 2.6 miles, 26 minutes or even 26 miles in the garden. The challenge went viral and within two days over £6.6 million had been raised. Feeling humbled by the efforts of so many people got us thinking about another important race that we are all invested in, the race to find an effective vaccine against SARS-CoV-2 (the virus that causes COVID-19). Serendipitously, this past week was World Immunisation Week. Consequently, this blog provides a progress report on the race to develop a vaccine and why, despite the race being more of a sprint than a marathon, the prospect of a reliable vaccine for use in the general population is still some 18 months away.1
How do vaccines work and why is developing a vaccine important?
Vaccines reduce the risk of disease by training the body’s immune system to fight a disease it has not come into contact with before.2 Vaccines are designed to prevent disease, rather than treat a disease. While it is possible to develop immunity as a result of contracting a disease, some infectious diseases can cause severe complications and be fatal.
Globally, vaccines save millions of lives every year.3 They not only provide individual protection for those who are vaccinated, but also help protect the community (‘herd immunity’) by reducing the spread of infection within a population.4 Indeed, as more people are vaccinated against a specific infectious agent, the transmission chains are interrupted and immunocompromised individuals (who cannot get vaccinated) become protected in the community.5
Since vaccines were first introduced, many infectious diseases that used to kill or disable millions of people, including smallpox, polio, measles and tetanus, have been mostly eradicated.6 Vaccines are given to healthy people to trigger an immune response so they can develop immunity before becoming infected. Therefore, they have to undergo extremely rigorous testing and safety assessments before being licensed for use, which typically requires years of clinical trials.7
Developing a widely available and affordable vaccine against COVID-19 might be one of our most effective ways of turning the tide on this pandemic. However, it should be noted that it is not yet known how much immunity will be conferred as a result of contracting COVID-19.8
Why does it take so long to develop a vaccine?
In December 2019, we published the tenth in our series of annual reports, Measuring the return from pharmaceutical innovation, which included our analysis that the average cost of developing a drug has increased from $1,188 million in 2010 to $1,981 million in 2019. A key reason for the increasing costs are the growth in the proportion of complex biologics in the pipeline and an expansion in cycle times (the length of time drugs are in development) This is despite efforts from regulators to introduce initiatives to accelerate drug development and approvals.
Our February 2020 report, Intelligent clinical trials: Transforming through AI-enabled engagement, explored further some of the hurdles facing drug development. It identified that the main reasons for delay and/or failure in getting a drug to market are challenges with recruitment and retention of patients on trials and the requirement to meet regulatory requirements. Even if regulators fast track the drug, this process still takes time. Moreover, vaccine development, like the development of other drugs, typically follows a linear sequence of steps (see Figure 1). Indeed, all vaccines currently in use have been developed through this linear model, which takes on average over 10 years to get a vaccine licenced.9,10 This will clearly not be fast enough for a COVID-19 vaccine.
Figure 1. Stages of development of new vaccines
Source: Wellcome Trust.11
Developing a vaccine as quickly and safely as possible will require a new R&D model that can be stood–up quickly, with many steps executed in parallel, before knowing what works and what doesn’t. This is something that hasn’t been done before and that needs to be done transparently and in full collaboration with regulators.12
The sprint to develop a vaccine against COVID-19
Since the viral sequence of SARS-CoV-2 was published on 11 January 2020, the global R&D effort to develop a vaccine against this virus has been unprecedented. Indeed, as the human and economic devastation of this pandemic has become evident, a global race for biopharma companies and researchers to develop a COVID-19 vaccine has become an imperative. One notable feature of participants in the race to find a treatment is that much of the research is based on collaborations between both private and public research organisations.
As at 30 April 2020, there are more than 110 vaccines currently being developed against SARS-CoV-2.13 Of those, eight candidates have entered clinical trials and most other potential vaccines for COVID-19 are in the animal testing stages.14 More than 70 per cent of the groups leading vaccine research efforts are from industry or private firms.15 Moreover, biopharma companies with experience in developing vaccines and/or with infectious diseases are partnering with more innovative companies such as AI for drug discovery companies.16
Today, as the race to find a vaccine accelerates and new technologies, which weren’t available the last time there was a global pandemic, are more widely used in drug discovery and development (such as digital technologies, advanced analytics and AI), there is increased optimism that the cycle times can be reduced. Nevertheless, despite impressive research efforts, from both academia and industry, which are accelerating the vaccine development process, the finish line is still at least 18 months away.17,18 If successful, this will be the fastest vaccine development ever seen.
There is almost universal acknowledgement that a reliable, affordable and widely available vaccine will play a crucial role in halting the COVID-19 pandemic. Because we need this vaccine urgently, development will need to be done differently. Many governments, global organisations and the biopharma industry are heavily investing in finding a vaccine. There is a lot of expectation being placed on the hope that vaccine development for COVID-19 will allow breakthroughs of new technologies and methods of development, which in turn will mean we are better prepared for any future outbreaks and thus able to respond faster.
As noted in the introduction, this past week was ‘World Immunisation Week’ and the focus of this year’s campaign is on ‘how vaccines, and that the people who develop, deliver and receive them – are heroes by working to protect the health of everyone, everywhere’. What better way to celebrate the incredible and enduring efforts by the global scientific research community and biopharma industry than developing this much needed vaccine in record time?
13 https://docs.google.com/spreadsheets/d/16DbPhF9OD0MHHtCR12of6yUcfiRzP_-XGkynEbnipds/edit#gid=2075421071, accessed 1 May 2020