A leading researcher in a study currently underway at the University of Oxford has confirmed that she is 80% confident that her team will be able to produce a COVID-19 vaccine come September. With human trials set to start in two weeks, the team is leading one of the most advanced studies on the virus in the world and looks set to find success. Professor Sarah Gilbert, head of the project, spoke to the Times on Saturday to confirm that her observations are “not just a hunch”, with the team looking at more and more crucial data every week that seems to confirm her confidence.
As we begin to understand where we are on the vaccine development time-line, it’s important to reflect on the difficulties our research sites must confront in order to bring us a cure. Today, we take a look at some of the big, industry-level issues and consider how we can work to tackle them.
What are the issues?
According to an article from the Journal of Microbiology, the industry faces 6 recurring issues that significantly hinder the development of vaccinations worldwide. They are as follows:
Too many trials today are failing to collect adequate preclinical data that, in some cases, is leading to a lack of detailed information on protective correlates of immunity. In short, studies are failing to fully detail signs of immunity in healthy patients that, in turn, contributes to product failure in clinical trials.
Equally, a lack of information on the infectious exposures of intended vaccine recipients means that research sites cannot fully understand the ways in which a virus is being transmitted.
Vaccines are to be used in populations with less-responsive immune systems, meaning that researchers must work to ensure that treatment is adapted to these conditions and is not suitable for healthy subjects alone.
Antigenic variation requires constant updating of vaccine formulations. Viruses have their own way of adapting to and combatting our current medications, so clinical research must be constantly revised in order to provide an effective treatment.
High costs of vaccine development result in premature abandonment of potentially useful products. It’s a terrible shame when the industry is producing the talent; yet, the financial support for their research is not always there.
Inadequate access to vaccines in poorer countries, especially those for use against tropical diseases, means that viruses originating from these areas are hard to isolate. This only leads to a faster, more unpredictable spread; with the disease tending to be studied with a series of complex mutations.
So, where are the solutions?
As shown by the list, there are a variety of issues at play in the industry today. So, it would be naive to assume that there is a one-size-fits-all approach to addressing these problem areas. Proposed solutions, as a result, fall into two categories: research solutions and financial solutions.
The changes that need to be made start in the models that research sites use in their initial planning. We need to develop more relevant animal models and more human samples must be collected and analysed in order to wider our understanding of the human immune system. We must also gain a greater understanding of the mechanisms underpinning currently used adjuvants; and, a vaccine delivery system specifically for use in immunocompromised populations must be developed.
Within this category, amongst the more technical solutions, is an evident need for wider public awareness of clinical research. Part of the solution also consists of monitoring the genetic variation of infectious organisms in our community. This means that, in order for research sites to accurately assess the health of the wider community, we should all regularly take part in clinical studies. Remember that ‘herd immunity’ only works when we know the majority of the flock are actually immune to disease.
These proposals, while equally complex in practical application, are the result of common sense. It is clear that more investment is needed in vaccine research. The increasing marketisation of vaccine development has meant that many research sites must now work to make a profit in order to survive, which puts the clinical research at the heart of a project at risk of exterior financial stresses. Private philanthropy has, thus, played a major role in providing the essential funding for researchers; but, while this has been effective in a multitude of ways, support can sometimes depend on a lengthy and complex application process that, as a result, disadvantages smaller, less-established companies.
That is why more government grants must be put in place to ensure that the focus remains on the issue at hand: tackling the virus. Equally, the same practice must be replicated for international clinical studies. While vaccines are being made available in developing nations through various initiatives such as the GAVI Alliance, the lack of interest in tropical diseases must be counteracted with financial incentives. Only when the right funding is in place can we ensure that crucial clinical trials like that being carried out in Oxford is sufficiently equipped to fight the virus crisis.
Here at Citruslabs, we've created the ideal patient recruitment dashboard to help any researcher improve their current metrics. With over 3 million patients on record, we ensure research sites are connected to a thoroughly educated and engaged pool of participants; so, it is no wonder why we have such high patient confidence! Now, we would say that other models are available - but this would be a lie. In fact, unlike that offered by other patient recruitment companies, our easy-to-use dashboard is the first-of-its-kind for the market; giving researchers a unique insight into their patients’ wants and needs via industry-leading technology. The future of clinical recruitment starts here.
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