«We have never dealt with such a large number of vaccinations. We don’t know what it brings »

Genetic vaccines are one of the newest developments in medicine. How do they work? Are they safe and will they be our future? Will the massive COVID-19 vaccination program be a success? The questions are answered by a specialist in clinical genetics from the Department of Medical Genetics of the Medical University of Warsaw – dr hab. n. med. Krzysztof Szczałuba.

1. Dr. Szczałuba draws attention to the problematic feature of mRNA-based vaccines – their transport and storage must take place under strict conditions. “When they are thawed and frozen again, they become inactive,” he says
2. The geneticist emphasizes that this is the first ever vaccination campaign on such a massive scale. It is not known what its effects will be
3. Read the first part of the conversation HERE
4. More about COVID-19 can be found on the TvoiLokony home page

Monika Zieleniewska, Medonet: Are genetic vaccines our future?

Dr hab. n. med. Krzysztof Szczałuba: Assuming that the RNA of the virus is not integrated into the host’s DNA. On this assumption, it is the future, because these vaccines can induce more permanent immunity.

In the case of mass vaccination, however, from a technical point of view, it is important to bear in mind the relative instability of RNA. Vaccines should be stored and transported in a specific way to fulfill their role. When they are thawed and frozen again, they become inactive.

We were a little less gentle with old-type vaccines, that is, those with inactive viral material – weakened or devoid of virulence. They are more resistant to transport, thawing or serving, which is why it is an important logistic issue.

Besides, do we consider genetic vaccines to be refined?

Vaccines with the participation of the so-called messenger RNAs have been largely studied in animal models. We have results from the operation of such influenza and Zika virus vaccines in animal models. We also have the results of research on mRNA anti-cancer vaccines. They are promising and appear to be safe and do not integrate into the host genome.

However, I repeat that the trials of vaccination with mRNA vaccines were mainly carried out on animals. If we look at human clinical trials, they looked at mRNA vaccines against influenza. This was in 2017 and the effects of vaccination were described as only moderate. Publications on this subject can be found, for example, in the Lancet (3). We don’t really know why, because we know that it is generally quite safe product, but the results of human studies differ slightly from the results of animal studies. We expected a better effect. Hence, in December 2020 it was found that there are generally no contraindications for mRNA vaccines, but there are also no guidelines, no formal guidelines when, how and with whom to apply this type of vaccination, because large clinical trials have not been conducted.

There are no contraindications, so are they safe?

Regarding safety, we have two small 2-month observational studies. The safety profile has been defined as large. It was also noted that after mRNA vaccines, some systemic or systemic adverse events may occur (4).

I also note the discrepancy between the indicators of the so-called a relative and absolute reduction in the risk of COVID-19 after vaccination. While the relative ratio (RRR) is around 95-97 percent, the absolute ratio (ARR) is even only 1 percent. (5). MRNA vaccines are promising, but one thing is to create a clinical trial on several or tens of thousands of people, and another to introduce them immediately into a mass vaccination program. This has already been done in Israel, where vaccines, including mRNA vaccines, have been administered to more than half of the population (the percentage of so-called vaccination in the population is around 120 with a maximum of 200) and vaccination is still ongoing. It should be noted that these are mass vaccinations of various groups, not only risk groups. Conventional influenza vaccination most often concerned risk groups, that is, the elderly or those with comorbidities, and was not of a mass nature.

More than four weeks ago, an analysis was published on the vaccination of the population of Israel, almost 600. people who received a viral mRNA preparation. This is a very big analysis. Vaccination results were interpreted up to 44 days. Of course, we can get different results after 60, 90 or 120 days. But we have what we have an analysis after about 40 days.

What is the result of it?

The first calculations suggested that the total number of deaths from the coronavirus was declining. Later, it was pointed out that it was impossible to count how many deaths there were, and to compare, for example, the data from mid-September 2020 to the current ones. It is necessary to take into account that some people had their first immunization at that time and others at that time, some received only one dose and others two doses of the vaccine, and the group sizes were different. On this basis, the number of deaths per day per examined person was calculated. Different results were obtained – an increase in their number. According to Herve Seligmann and Haim Yativ, the number of deaths compared to the unvaccinated group was even 15 times higher (6).

What are the conclusions of this?

Israeli scholars supported the authority of the French Nobel laureate prof. Luc Montagnier, who studied RNA viruses, incl. HIV and received the Nobel Prize for his research (7). Well, the general conclusion after these several dozen days is that mass vaccination leads to a possible increase in the number of deaths among the most vulnerable people (the elderly, with comorbidities). In turn, according to the authors, the mass of vaccination causes a decrease in the number of hospitalizations, because people with a mild COVID-19 course (middle-aged or young healthy people, not burdened with comorbidities), experience the infection even more gently. Thus, based on the analyzes of these scientists, the benefit of mass vaccination would be that those who are expected to be infected relatively easily would have had it even easier to avoid hospitalization, while those who had had the infection would be at even greater risk. However, it should be noted that these are data after several dozen days and we do not know what may happen later. Perhaps the results will be completely different. We can certainly draw one conclusion – we have not dealt with the mass vaccination of such a scale so far and we do not know what it entails.

This is our first time?

There has never been anything like this before. Of course, the medical literature emphasizes, especially in relation to Ebola, where contacts and contacts were also vaccinated, i.e. not necessarily people from high-risk groups, but, as above, of healthy people, that thanks to vaccination the infection did not spread (8).

However, epidemics come and go and we don’t really know why and what it will be like in the fall. Maybe the virulence of the virus will naturally decrease? What will be the death rate? What will be the number of hospitalizations?

So we are not XNUMX% sure that the mass vaccination will be as effective as we assumed?

There is an opinion that massive vaccination may lead to people turning away a bit. They will say that vaccinations for other diseases of people at risk will no longer be needed. And after all, vaccinations are a very important weapon, the only fundamental question is – on what front should they be used? To fight the SARS-CoV-2 virus as much as possible, but in what groups? Wouldn’t it make sense to give up massiveness and allocate vaccines to people at risk – the elderly and those with comorbidities, where the baseline mortality is higher? I cannot answer this question, but if the virus is prevalent in the population, I would be more selective, to focus on vaccination of risk groups.

Because if massively, then also children?

The December 2020 guidelines stated that vaccination against SARS-CoV-2 for all children was not recommended (9). The study by Jan Brauner and colleagues, which appeared in Science, states that the transmission of the virus in the pediatric and adolescent population may be the highest (10). The researchers say that the lockdown of schools was the biggest factor in reducing the spread of the virus.

In fact, we live in an era of lockdown and we do not know if it is effective, especially when it has been implemented almost everywhere, basically excluding the possibility of comparing populations in countries with and without lockdown.

It should also be remembered that a child’s immune system is constantly developing and is not entirely the same as in adults. In adults, the immune system still learns and remembers, but based on information inherited from childhood. Conventional, calendar-based, and study-based childhood immunization is extremely important and must be done. Experience has shown that they are effective against many serious diseases. However, we do not yet have the results of clinical trials of SARS-CoV-2 vaccines in the pediatric population.

This may interest you:

1. When will you get the second dose of the COVID-19 vaccine?
2. New report on vaccination reactions in Poland. How many deaths?
3. How effective is COVID-19 vaccines? [COMPARISON]

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