An expert panel “Info COVID-19. Ask – Decide” was organized at the Presidential Palace in Warsaw on Thursday evening. At the invitation of President Andrzej Duda, experts answered questions, among others, about the safety of mRNA vaccines against COVID-19, how vaccines are developed and the further course of the pandemic.
In an expert panel organized at the Presidential Palace in Warsaw, questions about COVID-19 were answered by: the doctor in charge of the Infectious Diseases and Paediatrics Department of the Hospital. Stefan Żeromski in Krakow Lidia Stopyra and president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, member of the Management Board of the European Medicines Agency Grzegorz Cessak.
The group of experts also included prof. Krzysztof Pyrć (Jagiellonian University in Krakow, member of the Healthcare Council of the President of the Republic of Poland), prof. Krzysztof Tomasiewicz (head of the Department and Clinic of Infectious Diseases at the Medical University of Lublin) and Dr. Artur Zaczyński, neurosurgeon, deputy medical director of the Central Clinical Hospital of the Ministry of Interior and Administration.
Safety of mRNA vaccines against COVID-19
The president of URPL was asked about the safety of mRNA vaccines against COVID-19. Grzegorz Cessak emphasized that they are not new products. Work on the development of this technology, he explained, began 30 years ago and concerned the development of cancer vaccines.
Cessak indicated that the entire registration process was carried out in full regime, i.e. all data on the safety, efficacy and quality of the drug had to be provided. – The clinical trials of the first, second and third phases have been completed – he stressed. The head of the URPL explained that some issues could be postponed, but without any exceptions in terms of safety and effectiveness.
Conditionality for approval of COVID-19 vaccines
When asked about the conditionality of approving COVID-19 vaccines, Cessak pointed out that there are several dozen registered drugs in Europe, e.g. in oncology, immunology, diabetology, neurology, cardiology and other areas that have conditional permits.
– This is because some data are not crucial at the time of approval, we can postpone them and obtain them at a later date. Just like today we learn about the vaccine booster, which at the time of registration was not a critical data and it could be postponed – he explained.
How vaccines are made
Professor Pyrć explained how vaccines are made. He indicated three types of them. – mRNA vaccines are vaccines that are really pure information sent to our cells that allows them to produce proteins, fragments of this virus, so that our immune system learns what this (virus – ed.) Looks like – he explained.
– In addition to mRNA vaccines, we also have vector vaccines, which – as to the idea – work very similarly: we deliver information to the cell what the virus looks like, the cell produces, and this medium, the information carrier, is here instead of pure mRNA, i.e. ribonucleic acid, another virus. At the moment, these are adenoviruses that carry this information, they cannot cause disease because they are inactive themselves, they are inert, but they provide information and enable the production of a protein, ‘he said.
“Importantly, we have a new type of vaccine that is already approved at this point. This is a new vaccine, a subunit vaccine where we deliver not information to our cells but proteins. Proteins that are produced outside our body, but also in cells, in this case in insect cells – he said.
Illness of vaccinated people
Prof. Thrott, in response to a question about serious COVID-19 cases in people vaccinated with two doses, said that “people who get vaccinated with two doses already know this, they lose immunity over time, so they need a third dose.”
– There may be many such cases. If we ask how many seriously ill people are there, it is worth noting that the question is to what extent the risk of a serious disease is reduced – pointed out the professor. He went on to see that in countries that were very well vaccinated against COVID-19, the death rate was much lower.
Vaccines do not mutate
The panel also asked whether the hypothesis that the vaccinated people are to blame for the non-extinction of the virus – which is subject to further mutations – is likely or the opposite and vaccination weakens the coronavirus.
Prof. Pyrć vehemently denied the claims that vaccines cause mutations. As he noted, vaccines are not a medicine – they do not act directly against the virus.
– What puts pressure on the virus that is trying to survive in our body is the immune system, and this immune system, when it “learns”, after vaccination or after getting infected, tries to suppress this virus and the virus tries to get it escape. If there is no infection, and this is to inoculate, then the virus cannot multiply, if it is not able to multiply, it is not able to mutate – described prof. Throw.
When the pandemic becomes endemic
Dr. Cessak was asked about the further course of the pandemic and whether and when it will turn into an endemic. This issue, he said, is being discussed by scientists who are talking about administering a fourth dose. – Scientists unanimously state that the frequency of administration of these successive boosters does not necessarily translate into effectiveness and transmission of the virus – he noted.
He recalled the recent announcement of the European Medicines Agency, which talks about the plans to administer the next doses of the vaccine on a seasonal basis – as in the case of the influenza virus, when there is a need to strengthen the immune system with subsequent waves of disease.
Vaccinations of children and pregnant women
Dr. Lidia Stopyra was responsible, among others, for to questions about childhood immunization. She stressed that the vaccine is safe and effective also in this age group. She pointed out that, contrary to the predictions from the beginning of the pandemic, it turned out that children can also be seriously ill with COVID-19, which was proved especially by the fourth wave, when many such cases were observed, as well as deaths in the youngest.
She emphasized that vaccinated children rarely require hospitalization. She also drew attention to the psychological aspect of the pandemic and the numerous suicide attempts by children.
When asked if the vaccine had an impact on fertility, the course of pregnancy, or the child who would be born one day, Dr. Zaczyński replied that there were studies which showed that “the vaccine certainly does not affect the course of pregnancy, the course of childbirth”. – Complications related to vaccinations are practically not observed in pregnant women. However, we observe complications in unvaccinated pregnant women. It can be seen in clinical practice – said Dr. Zaczyński.
Adverse post-vaccination reactions
He explained that “mRNA instruction alone does not affect the human genome.” – This is the instruction for the production of the protein that makes our body immune to the virus. However, it is not built into our genome in any way, so there is no substantive basis to believe that it limits human fertility – explained Zaczyński.
The President of URPL pointed out that if we compare the number of adverse vaccination reactions to the number of vaccinations performed in Poland, it turns out that NOP occurred only in 0.03 percent. vaccinations performed. He emphasized that the system of verification of adverse effects of vaccines functions very efficiently. NOP after administration of mild COVID-19 vaccines accounted for 0.024%, severe 0.003%, and severe only 0.001%.
Main photo source: TVN24