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The Covid-19 vaccine is the news of the moment. In the United Kingdom the administration has already begun, the United States has approved it and also in Europe the meeting has been advanced from December 29 to 21 to give the green light, with the clear objective of starting the campaign at the end of the year. But, are we really sure that this drug, developed in record time, bypassing most of the controls that are normally mandatory, is effective and above all safe? Loretta Bolgan, Ph.D. in chemistry and pharmaceutical technologies, researcher and scientific consultant, raised many questions about this. DiariodelWeb.it interviewed her.
Loretta Bolgan, the vaccination campaign against Covid-19 has already started in England and other countries around the world. Yet she preaches caution: why?
I carried out the first review of two vaccines, specifically the Moderna and the Oxford ones, when they were already under study and development, but had not yet obtained authorization. Then there is Pfizer’s, which works with the same technology as Moderna. But your security concerns are almost identical, because the virus is the same.
Please try to explain it to us in understandable terms.
Safety concerns were already well known from the days of the studies conducted for the Sars vaccine. At that time they had already developed a series of biotech vaccines and tested them preclinically in animals: as we do in ordinary times, not in times of pandemic. Unfortunately, those studies found that potentiation of the disease occurred in the majority of vaccinated animals. Instead of being protected, they developed a serious and often fatal complication. For this the studies were interrupted. Until today.
Does the same problem also apply to Covid-19?
Yes. In fact, when industries asked for a fast track, much of the discussion was on this topic. To date, preclinical studies, which in this case were conducted in parallel and not before clinical ones, do not allow us to verify the incidence of this very serious adverse reaction.
Why?
In the first place, because an animal species has been chosen that genetically does not develop the complications of infection, and that is no longer good. Second, because it was vaccinated using the original sequence of the Wuhan virus as antigen, and the reinfection was carried out with exactly the same virus without changes. In this way, it is evident that the antibodies that are formed are protective, and we cannot understand whether the potentiation of the disease develops. However, even in such optimal conditions, where they expected the animal to not even get infected, it actually got infected anyway. They claim that he did not develop the serious pathology, but we cannot know it, because that animal, in fact, does not present the complications.
In essence, the risk is that the vaccine not only does not protect, but even favors the aggravation of the disease?
Exact. This is the most well-known mechanism of vaccine damage, both to manufacturers and regulatory agencies.
And why weren’t these security risks taken into account?
This should be asked of the agencies. In my opinion, they have implied that the problem does not exist, but if we do not do the studies we cannot know. On the other hand, they could also say that it will be directly evaluated in vivo in vaccinated people.
It’s like saying that the first to be vaccinated will be human guinea pigs.
They will be in all respects.
This is quite concerning.
It is very disturbing. And I don’t support it: there are very important studies, also recently published in Nature, that have raised these fears. It is clear that industrial researchers are trying to downplay the problem, because they tend to claim that Covid-19 is a devastating and incurable disease, for which the only salvation is the vaccine. While there are risks, according to them, these are outweighed by the benefits.
But is this the reality?
I maintain the opposite. The overall mortality from Covid-19, even if it is overestimated, is still less than 0.5%. And there are other treatments as well, as evidenced by the significant results obtained by doctors who have used off-label drug mixtures. On the other hand, I repeat, we have no indication of the incidence of the fatal serious reaction to the vaccine. Therefore, in the absence of this information, we are not entirely sure that deaths caused by vaccines are less than those caused by Covid-19.
Are there any precedents for this?
It should be noted that vaccines such as dengue vaccines were withdrawn precisely because of this problem, after the death of several children: the company had underestimated the incidence of this adverse reaction and had ensured that they were marketed anyway.
So, is it legitimate to think that the interests of pharmaceutical companies are behind these maneuvers?
I think the pharmaceutical industries do their job: offer a product. And they have shown that they can create a vaccine very quickly, even in an emergency phase. The problem, in my opinion, is that when they requested authorization for the fast track we were still in the middle of the pandemic, so there were no exact estimates of the real danger of the virus. The use of a vaccine with a high risk of adverse reactions could be justified, but only against a virus with a very high mortality. On the other hand, in the case of Covid-19, for me this vaccine did not even have to be authorized and go on the market.
So the pharmaceutical companies did their job, but the controllers didn’t?
It should be understood what kind of evaluation they did.
If you were to give Italians some advice, would you tell them to take this vaccine or not?
It is a totally experimental vaccine, since to date we do not have reliable data on safety. Who will undergo the vaccine will be the guinea pig, volunteer or not. If vaccination were compulsory, this would be completely inconceivable: you cannot force a person to conduct an experiment. But even if it was optional, they could force us with blackmail: without the vaccine you don’t work, you don’t study, or you don’t move. This should not be accepted at all, in any way. Free choice is a right enshrined in our Constitution.
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