Aleksandra Moscicka-Strudzinska of NCRD: Under normal circumstances, it would take about 10 years to work on a vaccine against COVID-19
Why did the SARS-CoV-2 virus causing COVID-19 spread by adopting a pandemic scale, while the SARS-CoV-1 responsible for SARS caused outbreaks of lesser scope? According to NIH (U.S. government medical research agency) analyses, both viruses are capable of staying on surfaces for quite a long period of time, but people infected with SARS-CoV-2 may be infected before they have symptoms of the disease. Moreover, according to the NIH, there are 5-10 people with undetected infection per person diagnosed. As a result, until a vaccine or drug against COVID-19 is registered, we are doomed to maintain distance in social relations, increased hygiene and constant disinfection. What else do scientists know today about coronavirus, and especially how to effectively protect ourselves from it? Aleksandra Moscicka-Strudzinska – coordinator of the pharmaceutical and biotechnology area at the National Center for Research and Development – tells us.
What is the process of working on a vaccine? Apparently it takes many years?
Aleksandra Moscicka-Strudzinska (NCRD): Vaccines, are preparations containing antigens that are able to induce the development of specific, active immunity against an infectious agent or the toxin or antigen it produces. Their development and registration usually takes several years. The first stage of work makes it possible to determine what is to be included in the vaccine, i.e. what antigen is capable of inducing a high level of immune response. This requires both knowledge of the virus in question and the human body. Then a way to produce the antigen must be developed to proceed to testing. Gradually, subsequent studies use increasingly sophisticated models to verify how the preparation works. First in vitro using live cells, bacteria or tissue cultures, then in vivo administering the preparation to animals. It is necessary to determine the route of administration and make an initial decision on the concentration of the antigen. If, with appropriate standards, we already know how to produce the preparation in the amount needed for administration to a group of volunteers in a clinical trial, we can take the next step – to start research with humans. This stage, for ethical reasons, is subject to the most stringent rigor, but it allows us to make sure if and how the preparation works on the human body. We cannot bypass this stage. On the one hand, we must be sure that the preparation is not dangerous, but we must also confirm that it works – causes immunization. Probably each of us can imagine the consequences of the former aspect, but what does the latter mean? Well, we need to make sure that we don’t start giving almost the entire population of the world a preparation that gives us false confidence that those who have taken it are immune to contracting COVID-19. The clinical trial is also expected to help determine more details: the tolerance of different doses of the vaccine or the need for booster doses. All three phases of the clinical trial could take up to seven years to complete.
In cases such as the SARS-CoV-2 virus, can this process be accelerated?
Due to the seriousness of the problem, the whole world has intensified its efforts: the work of scientists in laboratories and doctors in hospitals, as well as the efforts of registration officials. Currently, more than a dozen research groups are working independently on a vaccine. They are supported by both states and private donors. The company, which was the first to begin administering its vaccine to humans in March as part of the first phase of clinical trials, has partnered with the NIH and received support from CEPI (a foundation that funds private and public research into vaccine development). With an eye toward accelerating the work, we are already hearing that preparations have begun for a potential second phase of clinical trials. In Europe, the European Medicines Agency (EMA) has joined the fight against the pandemic and launched its special procedure for emerging health threats. As a result, both scientists and companies developing a vaccine can count on scientific advice during the design of a clinical trial, assistance in optimizing the vaccine development and evaluation process. It may also be possible to release it for marketing if the benefit of immediate availability outweighs the risk of having less comprehensive study information than is normally required. In contrast, clinical trials cannot be eliminated from the entire vaccine development process, nor can clinical trials be conducted according to a protocol that would unnecessarily expose volunteers. So despite all efforts, we must expect that it will be a minimum of several months before the vaccine is available.
And what is happening on the topic of vaccine research in Poland?
The Medical Research Agency has decided to launch its own study, which will be carried out in partnership with Polish and international centers. The agency has selected three Polish centers for cooperation: Lukasiewicz Research Network – Institute of Biotechnology and Antibiotics with the team of Prof. Marcin Drąg from the Wroclaw University of Technology, the National Institute of Oncology in consortium with the Institute of Biochemistry and Biophysics of the Polish Academy of Sciences and the Medical University of Warsaw, and the Medical University of Wroclaw. The idea behind the vaccine under development is to focus on combining a nanobody with a bacteriophage.
The potential to carry out such an ambitious project in Poland can also be evidenced by previous research by beneficiaries of the National Research and Development Center. It is worth mentioning, for example, two projects by female researchers from Gdansk. Under our LIDER program, Dr. Ewelina Król developed a vaccine against the Zika virus, and MA Beata Gromadzka developed the NaNoEXpo system, which modernizes the production process of new-generation vaccines. The project of the Institute of Biotechnology and Antibiotics in Warsaw entitled “Influenza vaccine – innovative preparation of subunit antigens” was also successful.
So how can NCRD today support the scientists and entrepreneurs who have undertaken work on the COVID-19 vaccine?
We have several programs supporting the development of medicine (e.g., the Strategmed Program) or new medicinal products (e.g., the INNOMED program and InnoNeuroPharm). In our portfolio of funded projects, we do not yet have any that are directly related to a drug or vaccine against coronavirus infection. However, we know that our beneficiaries are working on modifying their solutions and applying them to fight COVID-19, for example, SensDX from Wroclaw, which with NCRD support developed a test for rapid flu detection, today wants to use its technology for coronavirus diagnostics. In the field of medicinal products, Celon Pharma S.A. has initiated a strategic program to test, verify and search for an effective COVID-19 treatment, relying on solutions already developed under previous projects co-financed by the National Research and Development Center.
We look forward to the activity of potential applicants and the submission of new applications for solutions dedicated to the COVID-19 pandemic to the Fast Track program. The call for proposals for large companies and their consortia is open until April 20, and the call for proposals for SMEs and consortia with their participation starts on April 21. We are aware that in the era of globalization, following the SARS and MERS epidemics, the COVID-19 pandemic is creating new scientific challenges, and we believe that Polish research groups will actively join the search for innovations dedicated to the latest needs with financial support from NCRD.
The topic of vaccines is not only a research challenge, but also an educational and social one. Vaccination raises a lot of emotions in Poland even today, with many people claiming that it weakens the body’s natural protection. What does the scientific world say on the subject?
There are still myths operating in Poland that, if they appeared today, would immediately be pointed out as “fake news.” The effective action of vaccines is based on the natural defense mechanism of organisms and does not weaken it. On the contrary: it strengthens it by showing what the enemy looks like, but without having to suffer the full consequences of coming into contact with an active pathogen. At the same time, it is worth remembering that the rigor of vaccine development, testing and marketing is even greater than for drugs. Each vaccine batch is additionally tested by a state quality control laboratory. In light of this, it is incomprehensible to refuse mandatory vaccinations without medical indications. We are addressing this problem in a new NCRD competition within the framework of the GOSPOSTRATEG Strategic Program, which includes, among other things, vaccine refusal as a challenge for state health policy, social trust, public health and family and social policy. This topic was submitted by the Ministry of Health. The goal of the project, which we can subsidize, is to develop tools to induce patients to reject false medical claims. Applications by May 22 may be submitted by scientific units and consortia of scientific units carrying out projects as part of their non-economic activities. Detailed information is available on the NCRD website.
As we eagerly await the creation of a vaccine against COVID-19, we must be aware that the existence of a vaccine does not automatically eliminate the virus in question from the population. Only mass vaccination, without unnecessary exceptions, can eliminate the pathogen. This is extremely difficult, but it has already succeeded once – in 1980 the World Health Organization declared smallpox eradicated in the human population.
