Research teams from around the world are working to find an effective vaccine against COVID-19. As it turns out, Polish researchers also deal with this in cooperation with the Medical Research Agency. Aleksandra Mościcka-Strudzińska from the National Center for Research and Development talks about how such a vaccine is made.
Why is producing an effective COVID-19 vaccine so important? Scientists say onlymass vaccinationcan eliminate the coronavirus from the environment. Therefore, until it is invented, we will be doomed to maintain a distance in social relations, increased hygiene and constant disinfection. Polish researchers also joined the race - the Medical Research Agency in cooperation with 3 Polish research centers started its own research.
- What is the vaccine development process? Apparently it takes many years?
Aleksandra Mościcka-Strudzińska (NCBR):
Vaccines are preparations containing antigens that are capable of inducing the development of specific, active immunity against an infectious agent or produced by a toxin or an antigen. Their development and registration usually takes several years.
The first stage of the work allows to determinewhat is to be included in the vaccine , i.e. which antigen is capable of inducing a high level of immune response. This requires both knowledge about the virus and the human body.
Then you need to work out aantigen production methodto proceed with the testing. Gradually, in subsequent studies, more and more complex models are used to verify how the preparation works. First in vitro with the use of live cells, bacteria or tissue cultures, then in vivo by administering the preparation to animals. It is necessary to determine the route of administration and make an initial decision about the concentration of the antigen.
If, while maintaining appropriate standards, we are already able to produce the preparation in the amount needed to be administered to a group of volunteers as part of clinical trials, we can take the next step -start research with human participation .
This stage, for ethical reasons, is subject to the most restrictiverestrictions , but it allows you to make sure whether and how the preparation works on the human body. Notwe can 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 - it causes immunization. Probably each of us can imagine the effects of the first aspect, and what does the latter mean?
Well, we have to make sure that we do not start giving almost the entire population of the world a preparation that will give us false confidence that the people who took it are immune to COVID-19. The clinical trial is also intended to help determine more details: tolerance of different doses of the vaccine or the need for booster doses. All three phases of clinical trials can takeup to 7 years .
- Can this process be accelerated in the case of SARS-CoV-2?
AMS:Due to the importance of the problem, the whole world has stepped up its efforts: scientists in laboratories and doctors in hospitals, and the activities of registration dossiers. Currently, over a dozen research groups independently from each otherare working on thevaccine. They are supported by both states and private donors.
The company that first began administering its vaccine to humans in the first phase of clinical trials in March has partnered with the NIH (the US government medical research agency) and received support from CEPI (a foundation that finances privately and publicly funded research into the development of vaccines).
- With the speed of work in mind, we hear today about the start of preparations for a potential second phase of clinical trials.
In Europe, the European Medicines Agency (EMA) has stepped in to tackle the pandemic and launched itsspecialprocedure for emerging he alth threats. As a result, both scientists and companies developing the vaccine can count on scientific advice in the course of designing a clinical trial, help in optimizing the process of vaccine development and its evaluation. It is also possibleto market itif the benefit of its immediate availability outweighs the risk of having less comprehensive research 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. Therefore, despite all efforts, we must reckon with the fact that it will bea minimum of several monthsbefore the vaccine is available.
- And what is going on in the topic of vaccine research in Poland?
AMS:The Medical Research Agency has decided to start its own research, which will be carried out in partnership with Polish and international centers. The agency selected for cooperation3 Polish centers : Łukasiewicz Research Network - Institute of Biotechnology and Antibiotics with a team of prof. Marcin Drąg from the Wrocław University of Technology, the National Institute of Oncology in a 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 Wrocław.
The idea of the vaccine under development is to focus oncombining nanoparticles with bacteriophage . The research on the beneficiaries of the National Center for Research and Development (NCBR) to date may also prove the potential for the implementation of such an ambitious project in Poland.
It is worth mentioning, for example, two projects by researchers from Gdańsk. As part of our LEADER program, Dr. Ewelina Król has developed a vaccine against the Zika virus, and Beata Gromadzka, M.Sc., has developed the NaNoEXpo system, which modernises the production process of new generation vaccines. The project of the Institute of Biotechnology and Antibiotics in Warsaw en titled "Influenza vaccine - innovative production of subunit antigens."
- How can the National Center for Research and Development today support scientists and entrepreneurs who have undertaken work on the COVID-19 vaccine?
AMS:We have several programs supporting the development of medicine (eg the Strategmed Program) or new medicinal products (eg the INNOMED program and InnoNeuroPharm). In our portfolio of funded projects, we do not yet have projects that are directly related to a drug or vaccine against coronavirus infection.
We know, however, that our beneficiaries are working on modifying their solutions and applying them to fight COVID-19, e.g. the SensDX company from Wrocław, which with the support of the National Center for Research and Development, has developed a test for rapid flu detection, today wants to use its technology to coronavirus diagnosis.
In the field of medicinal products Celon Pharma S.A. initiated a strategic program of testing, verification and search for effective COVID-19 treatment, based on solutions already developed under previous projects co-financed by the National Center for Research and Development.
Fast Track ProgramWe count on the activity of potential applicants and the submission of new applications for solutions dedicated to the COVID-19 pandemic for the Fast Track program.The call for proposals for large enterprises and their consortia continues until April 20 , andfrom April 21the call for applications for SMEs and consortia from theirshare. We are aware that in the era of globalization, after the SARS and MERS epidemics, the COVID-19 pandemic creates new scientific challenges and we believe that Polish research groups will actively engage in the search for innovations dedicated to the latest needs with the financial support of the National Center for Research and Development.
- Vaccinations are not only a research challenge, but also an educational and social challenge. Even today, protective vaccinations arouse a lot of emotions in Poland, and many people say that they weaken the natural protection of the body. What does the scientific world say about it?
There are still myths in Poland that, if they appeared today, would immediately be indicated as "fake news". The effectiveeffect of vaccinesis based on the body's natural defense mechanism and does not weaken it. On the contrary: it strengthens it by showing what the opponent looks like, but without having to bear the full consequences of coming into contact with an active pathogen.
At the same time, it is worth remembering that the rigor of the development, testing and marketing of vaccines is even greater than for drugs. Each batch of vaccine is additionally tested by the state quality control laboratory. In light of this,refusal of vaccinationscompulsory vaccinations without medical indications .
This problem is raised in the new NCBR competition under the GOSPOSTRATEG Strategic Program, which includes, inter alia, refusal of vaccinations as a challenge to the state he alth policy, social trust, public he alth and family and social policy.
This topic was reported by the Ministry of He alth. The aim of the project, which we can finance, is to develop tools to encourage patients to reject false medical claims. Applications by 22 May may be submitted by research units and consortia of research units implementing projects as part of their non-economic activities. Detailed information is available on the NCBR website.
While waiting impatiently for the development 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 vaccinations, without unnecessary exceptions, eliminate the pathogen. It is extremely difficult, but it has already worked out once - in 1980, the World He alth Organization declared smallpox eradicated in the human population.
- COVID-19 Causes China Coronavirus: Symptoms And Treatment
- Coronavirus vaccine: when will it be ready?
- This is what the lungs of a COVID-19 patient sound like!