Confronted by a global emergency, scientists raced out coronavirus vaccines in record-breaking times without cutting corners. This speedy approach could change the future of vaccine research and science. In the final part of this interview-based article series Dave Selkirk, CEO and founder of Whitechurch Pharma & Biotech Consulting, considers how the COVID-19 experience will impact the future of clinical trials.
I think it will affect trials going forward, and there are a couple of important things to consider with that.
Because of the pandemic, you have global regulatory agencies working with pharmaceutical companies to accelerate timelines. Normally there is a queue. You submit your data to the regulators around the world, and there is a waiting list. Depending on whether the therapy is a breakthrough or offers some enormous benefit for a rare disease, you can jump the queue. For every regulator worldwide, COVID has gone to the front of the line ahead of everything else. The degree of partnership between the manufacturers of the medications and regulators is unprecedented, and that has accelerated everything.
The other point to emphasize is that the development of the vaccine hasn’t started from scratch. The COVID-19 virus is a SARS virus, although not exactly the same as the SARS virus that came about 17 years ago. However, it is still a SARS virus, and a number of companies had already started research development on that family of viruses so they could skip ahead a couple of years.
Therefore, efficacy was able to be established much quicker, and the genome was sequenced at unprecedented speed and made publicly available around the world. Many companies were researching the virus because it was designated a pandemic and posed a threat to society.
COVID-19 vaccine development certainly appeared to be at warp speed.
I think it has demonstrated what is possible when researchers and regulators choose to partner to bring medicines to the world.
However, we must bear in mind long-term safety, and by definition, we do not have long-term safety data for these vaccines. However, I think the benefit outweighs the risks, certainly in the at-risk populations, such as the elderly, those with immune-compromised systems and respiratory compromised conditions. As we have seen from the data, there is an unacceptable mortality rate in those groups.
Regarding long-term safety data, we must have surveillance systems worldwide to collect the information on it. The first regulator to approve the Pfizer/BioNTech vaccine reported some incidences of anaphylaxis fairly quickly in the UK, and the world needs to understand that with every single vaccine, there is always some incidence of anaphylaxis, and so this is not an inherent fault with the accelerated research development form of the COVID-19 vaccine.
I think it is extremely exciting that the vaccine has come about this quickly and that there will be a number of other vaccine options because no single vaccine developer can make a global number of supplies. Also, for these types of medicines, it has been to the world's shame that they are administered disproportionately to the western world. They need to make sure it is available globally. It's not just the west that is being impacted by this disease.
Is the COVID-19 experience going to have a knock-on effect for any company developing therapeutics going forward?
I think what we have demonstrated is in an emergent situation that industry and regulators can partner together to truly do things at a speed that previously was believed to be impossible. The challenge now will be if you want to move heaven and earth to make this happen, what criteria make it worthwhile?
For example, acne. Now I’m not minimizing it, but a new treatment would not save people’s lives and perhaps wouldn’t merit changing the whole juggernaut of systems as opposed to a cure for all cancers. So, I think the criteria becomes: is this a breakthrough therapy? Is this truly a leap forward in either safety or efficacy relative to what is currently available to patients and has moved the machine? We have demonstrated that moving the machine can be done way more efficiently than people previously thought.
What other lessons have we learned from COVID-19 vaccine development?
We have learned how to do things virtually. Before COVID-19, the clinical trial industry was set up, so participants physically go to a lab, hospital, or clinic and interact face to face with a clinician.
We have discovered through the pandemic that a great many of these things that previously nobody believed could be done in a virtual setting can be. Clinicians can see patients virtually, and many home healthcare companies have emerged where clinicians go to patients’ homes, which is a godsend for non-ambulatory people.
So, protocols are now being designed around conducting clinical trials as efficiently as possible. And because there are many cases where it is not appropriate for patients to self-diagnose or self-report because you need a trained clinician to make an assessment, the question becomes, can this be done in a virtual environment. If not, can the clinician go to the patient rather than the patient go to the clinician?
In the past, perhaps you had a patient who forgets their appointment or didn't feel good so missed their appointment. If they missed too many, they would be out of the study and replaced, which meant the trial going on for much longer. Whereas now, through all these virtual connections, there are very few scenarios that absolutely cannot be done in a virtual setting. So, it has been exciting to think through protocol design and how that can be done.
The other piece is wearables. You used to have to go to a physician, and they would take your blood pressure and heart rate and maybe measure your weight every X number of weeks, days, or months. Now you have wearables that track those measurements 24/7 while you're awake and while you're asleep. You don't have to record them.
All of these things accelerate clinical trial conduct, and that makes drugs available quicker. And so, all of those lessons that I think we have learned throughout 2020 are here to stay. I don't want to say in any way, shape, or form that the clinician is irrelevant. I don't think they will ever be irrelevant. However, the way clinicians and patients interact is forever changing with the incorporation of technology.