Groups of scientists from around the world are working on a vaccine and a cure for the new coronavirus. When can we expect a vaccine on the market? In an interview about the role of clinical trials and the process of introducing the vaccine on the market – Tomasz Dąbrowski, Pratia’s Board of Directors President, the largest network of clinical research centers in Poland, offers his insight.
When can we expect a coronavirus vaccine? What does the vaccine marketing process look like?
Tomasz Dąbrowski: First of all, we have to distinguish between two aspects. Vaccine, or a panacea for immunization against the virus (building antibodies). A medicine, or panacea, for a disease that will arise as a result of a virus.
When it comes to vaccines, the manufacturing process is quite long and complicated. Due to the fact that vaccines are given to hundreds of millions of people (huge populations), the mode of action and clinical trials are under special supervision.
What is the course of action as regards clinical trials for the vaccine?
The standard testing process starting from vaccine development and animal testing begins with the first phase in healthy volunteers. In the case of vaccines, it can be from a few to a dozen or so people who receive the vaccine in very controlled conditions.
The patient’s biochemical parameters are observed and the appropriate dose is determined. At this time, we also observe possible so-called adverse events (i.e. side effects caused by the administration of a new drug).
The second phase of vaccine testing is when the drug is given to hundreds of patients (usually between 100 and 200, but there are also studies where up to 1,000 patients are included). This is the time when it is examined whether the vaccine is actually effective and whether the organism’s immunity is triggered by producing antibodies.
From then on it proceeds to the third phase of clinical trials, which is a population study involving a very large number of patients – even tens of thousands. This is the time when the human body is tested for real virus activity, i.e. during epidemics (e.g. influenza).
Here we can observe how the human body becomes resistant to the effects of the virus during contact with it and what are the possible side effects in a very large population.
After this stage, the drug can already be registered – that is, if it successfully passes all phases of the study. The drug may, but does not have to enter the fourth phase – observation. This is the time during which additional optional parameters are being tested to better understand the effect of such a vaccine, while it is commercially available on the market.
The vaccine, e.g. against COVID-19, can be based on many models, the main ones being:
● A vaccine developed from the virus’ genetic material of DNA or RNA (which seems to be a great opportunity, but this type of vaccine has never before been registered in the world). Under no circumstances should clinical trials of such a vaccine follow a shortened clinical trial pathway for patient safety reasons. Work on this type of vaccine was already underway during the SARS epidemic, but the crisis had passed and companies abandoned their development.
● A vaccine developed from live, attenuated viruses or segments of the pathogen is given to the immune system, usually as an injection, and at a low dose to induce the system to produce antibodies against the pathogen. Antibodies are a type of immune memory that can be quickly mobilized again and triggered to fight the infection. This is how most flu vaccines work in the world today.
Traditionally, the body’s immunity was achieved using live, weakened forms of the virus, or its segments, or full form after inactivation (e.g. under the influence of heat or chemicals). However, these methods have their drawbacks. The live form can in fact continue to evolve in the patient, causing the host’s disease, while higher or repeated doses of inactivated virus are required to achieve the necessary degree of protection.
Some Covid-19 vaccine designs use proven methods, others use newer technology. American Novavax – constructs, for example, a „recombinant” vaccine. The method consists of isolating the genetic code on the „increase in protein” on the surface of Sars-CoV-2, which is part of the virus most likely causing an immune response in humans. It is then pasted into the genome of bacteria or yeast – forcing these microorganisms to produce large amounts of protein.
Still another approach to the vaccine is bypassing the protein and building the vaccine based on the genetic instructions alone. This is the case with the American company Moderna and the German company CureVac, which are working on vaccines against Covid-19 from RNA.
It is worth adding that at CureVac, it is the Polish doctor who manages the team of scientists who are working on the coronavirus vaccine. In turn, another Polish professor is leading researchers from Australia, who for the first time described how the human body is fighting SARS-CoV-2.
It could definitely be stated that we have good scientists. That is why this type of research is developing so fast. There are more and more very good Polish biotechnology companies operating, e.g. in oncology, developing new molecules.
As companies involved in conducting and designing clinical trials (Pratia and Clinscience) within the NEUCA Capital Group, we also try to support local companies and universities in attempts to create new drugs for coronavirus. We are in talks with several such entities and scientists. We implement many activities in this area pro bono.
Can the vaccine launch process be accelerated?
There are currently over 35 clinical trials of the COVID -19 vaccine in the world. Some of them have already started human studies. In parallel, there are dozens of clinical trials underway concerning drugs that can combat complications caused by the virus, in particular those caused by pulmonary fibrosis.
Bearing in mind the very rigorous process of conducting clinical trials, especially those in the field of completely new therapies – the only thing we can do today is to accelerate the process of issuing consents to start a clinical trial and launching projects faster. The claim that we are able to „deliver” a registered and safe vaccine earlier than within 12-18 months seems to be irresponsible. If we add the fact that exactly the whole world will want to use it, we will encounter another huge barrier with the production of this specific product and satisfying the supply.
Johnson & Johnson announced that if their COVID-19 vaccine is effective, it could appear on the market early next year. The company would then like to produce one billion vaccines by the end of 2021.
By the end of 2021 – this is realistic. Of course, as I said before – it all depends on the results of clinical trials. Let’s remember that there is no genetic vaccine in the world yet. And „traditional” vaccines also have their pros and cons.
What is the process of putting the drug on the market? Can the mode of action be somehow sped up here?
When it comes to medicines, the marketing process looks similar to the vaccine. Usually, clinical trials take place in a smaller population and drugs are given to sick patients, not healthy volunteers. The process of placing the drug on the market cannot be accelerated (apart from improving administrative efficiency).
Is there a significant amount of awareness of what clinical trials are in Poland?
I started with the first clinical trials together with my mother in 2001. It can be said that these were the beginnings of clinical trials in Poland. A lot has changed since then. Today, clinical research is a huge industry and the awareness of them is constantly increasing among Poles (patients and doctors).
Poland, thanks to its well-established centers conducting clinical trials, has gained a very strong brand around the world. Last year, to further support clinical trials, the Medical Research Agency was established. It was also the best year in terms of the number of registrations of new clinical trials. We have exceeded 600 registrations of new clinical projects – to compare it with previous years, this number ranged from 350 to 450 registrations.
Pratia, which I have the pleasure to manage, currently conducts over 200 clinical trials involving over a thousand patients. We have a very deep sense of what we do being our mission. Every day, thanks to our projects, we are able to give the opportunity for treatment to the patients who need it the most, i.e. those with oncological diseases. Currently, about 40 percent of our patients are such people.
It is estimated that in Poland over 30,000 patients take part in clinical trials annually.
Together with my team we work in the clinical trials field because we believe that by providing cutting-edge therapies we help our patients and contribute to the creation of new drugs that can save not only our lives but also our health.
What do clinical trials look like in other countries?
One can say that it varies according to each individual country. Western countries – Germany, France, Spain, or the United States, carry out a more significant amount of clinical trials. These are the markets in which the share of the public payer in reimbursement of expensive therapies is very high. Therefore, they naturally constitute a great commercial potential for pharmaceutical companies. Globally, the United States still remains the largest market for clinical trials today, but countries such as China are beginning to catch up with them.
In Eastern European countries, where healthcare is often underfunded, clinical trials are an alternative access to modern therapies. For example, an oncologically ill patient usually receives older generic drugs from the state. As part of clinical trials, he has a chance to access the latest biological therapies that he simply couldn’t afford. That is why, in Eastern Europe, clinical trials are developing so well, and patients are willing to participate. In addition to the availability of therapy, they gain very good access to professional care, research and recognized specialists, often leaders of opinion without long queues.
In highly developed countries – one of the reasons for participating in a clinical trial is also a high level of awareness. Satisfaction with help in creating new drugs for the next generation is also important for participants.
* Pratia is the largest network of clinical research centers in Poland. It consists of seven professional medical facilities located in the largest cities in Poland and four Partner Centers. The Pratia clinical research center is characterized by experience, quality, and, above all, patient care.
To read the interview in Polish, please follow the link: https://www.swiat-zdrowia.pl/artykuly/szczepionka-i-lek-przeciwko-covid-19-jak-wygladaja-badania-nad-szczepionkami