THE REACTIONS are there, perhaps too many. There are many who admit it. Starting with AIFA which, in the note on vaccination surveillance of 10 March, writes verbatim: “Overall as of February 26, 2021, 30,015 reports have been evaluated out of a total of 4,118,277 doses administered for all vaccines“. A remarkable reported event rate: 729 per 100,000 doses. Certainly, adds Aifa, “higher than what is usually observed for other vaccinations, for example for the flu”. The most common manifestations (in 93 percent of cases): fever, headache, muscle / joint pain, injection site pain, chills and nausea, were recorded on the same day of vaccination or the next (87% of cases). The significant ones, whose causal link with vaccinations is being evaluated, correspond to 6.1 per cent of the total, which is equivalent to 44 serious events (mainly affecting the central nervous system) every 100,000 doses administered. In short, do we still have to sleep peacefully or would it be legitimate to ask a few questions?
“Unfortunately, the news on the precautionary suspension of the withdrawn batches raises fear and confusion”, admits the virologist of the University of Milan Maurizio Pregliasco who is also medical director of the Galeazzi Institute.
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If our Medicines Agency reveals a significant number of adverse reactions, there are also those who had anticipated the alarm with numbers that photograph an Italy in poor shape compared to other European countries. The update to which it refers Annamaria Colao, holder of the Unesco Chair for Health Education and Sustainable Development of the Federico II University of Naples, dates back to February 2 and was published by the European Surveillance System Eudrasurveillance managed by the European Medicines Agency (EMA). The conclusion is the same: we hold the worst case history in Europe for vaccine-triggered events. Both the common ones and therefore more or less expected, and the serious ones and, therefore, that arouse greater concern. “Just take a look at the three graphs (shown below, ed) to realize the numerical discrepancies. And it’s not stuff of one or two points, but of percentages that make you think ”, observes the professor. Without going into the merits of the mechanism that triggers individual reactions, the first doubt, beyond the real or presumed risks, concerns our local anti-Covid prophylaxis campaign. “Aren’t we going to be doing something wrong in the strategy adopted?”, Ventures Colao.
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Pregliasco replied immediately: “I think the protocol is correct. The adverse event data are however negligible overall. And the number of reports depends on the sensitivity and attention of the subjects and health professionals which, in this case, is higher than the norm, while for other drugs the detection is often neglected. Furthermore, the extent of the effects, which disappear by themselves, is not relevant “. But opinions don’t always agree. And to the words of Pregliasco he replies Antonella Viola, immunologist at the University of Padua and director of the Pediatric Research Institute: “I don’t think the greater number of side effects is related to protocol problems. The real difference is in the vaccinated population, much younger in our case because we started with health professionals, with an average age of around 46. And in young people, the immune system has stronger responses. In the coming months we will see the effects on the elderly population ”.
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The comparison with other European nations, of the Community and beyond, are eloquent. In Italy – it is the Ema data to reveal it – there were 32,866 adverse reactions. We are first. “This had already been clarified by AIFA 15 days ago – recalls Colao – when it disclosed the over 7,000 events resulting from the administration of the only vaccine available at the time, the one produced by Pfizer / Biontech. Now, from the European Surveillance System comes the news of a further important increase. In pole position there are reactions affecting the central nervous system, in second place for frequency and of serious intensity in 30% of cases ”. France, which is in second place in the ranking, recorded 9691 adverse events, almost four times less than Italy. Following are Holland with 8698, Spain with 7415, Germany with 4582. If only our nation stands at such high and different figures, it is evident that the figure is off the scale and there is something wrong.
Colao, who reiterates that she is a convinced yes-vax, felt compelled to investigate. And therefore, with the epidemiologist Weather in Prisco Piscitelli, his collaborator for Unesco, went through the documents available on the Ema website: “We questioned the validity of our vaccination protocol, focusing on the data of Great Britain which from the beginning vaccinated the elderly population with a single dose . Unlike our country where the booster dose was also injected, in line with the protocol registered by Pfizer and Moderna and approved by Ema. In this case, the hypothesis of a higher rate of reactions would partly depend on the double dose and on the fact that we have vaccinated a relevant group of non-elderly subjects ”. A thesis that recognizes the explanation of the numerous side effects, as a result of the vaccination of young people between 20 and 40 years, those who probably enjoy the most lively immune response.
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And on this point, Pregliasco intervenes by adding that “the second dose is foreseen by the registration studies and guarantees a higher and more lasting protection. Studies to perfect the vaccination schedule are welcome, as always happens for every vaccine after registration, and even more so for these who have had an emergency authorization “. Specifically, Viola also agrees: “With mRNA vaccines we cannot use a single dose because we risk generating an immunity that is not maintained over time or that is not very effective against variants. Also, Aifa’s data says there’s no difference in the number of events reported following the first and second dose, so that’s not the problem. As I said before, the point is the age of the vaccinated: in young people the immune system has stronger reactions. “
The surveillance system
Another factor, no less significant but useful for interpreting the numerical difference in reports, would be the methodology followed in Italy for recording reactions. “Without attributing particularly virtuous behaviors – reasons Colao – probably thanks to the 15-minute stop of observation of the vaccinated even the slightest reactions were recorded by the monitoring”.
No alarmism
The interpretative hypotheses are the result of the analysis of numbers and individual procedures, according to Colao. But he warns: “Reading the data must not question the validity of vaccines or even induce in citizens the suspicion that instead of protecting they are taking serious risks”. But so many reactions, regardless of the underlying reasons, would require a change of course in the vaccination procedure? Since February 10th, Colao has been advocating the need not to administer the second dose to the carpet: “We should evaluate the antibody response after the first, and only recall those in which the quantity of antibodies has proved insufficient to cover them from contagion. And this will also allow us to expand the range of the vaccinated population and reduce the circulation of the virus, achieving herd immunity in a short time. Today it seems to me that the government is moving in this direction ”.
Without controversy comes Viola’s dissenting clarification: “The scientific community considers it dangerous to change the protocols of highly effective vaccines such as Pfizer and Moderna. The two doses are needed and it is not necessary to do serological tests before undergoing the vaccination. Those who have had the disease in recent months can postpone the second dose “. On the other hand, Pregliasco recalls how “difficult and burdensome it is to systematically perform analyzes to evaluate the antibody response” and how it is necessary to deal with another aspect: “Not all the methods adopted to carry them out are adequate to measure the actual intensity of the response: And today controlled studies on population samples are underway for the evaluation of the case “
More sensitive women
It may be because they are more careful, they perceive every slightest change better, the fact is that the numbers on the differences certify it: women have reported the majority of adverse events to the vaccine. 907 reactions out of 100 thousand doses administered in women compared to 424 reported by men. Virtually more than double. This time, a percentage comparable to that of other European countries. And this too would be an element to be explored, bearing in mind that interpretative theories already exist. Starting from a different immune response in women, which would seem to affect, according to recent studies and as the Ema Eudrasurveillance website writes, “on the frequency and severity of adverse reactions, especially in relation to fever, pain and inflammation”. Viola is not surprised by these data: “Women have a stronger immune system, which also reacts more to vaccines. This allows them to be more protected against infections, thus protecting the fetus, but exposes them to more inflammatory reactions as well as to autoimmune diseases ”.
Pregliasco invites caution to avoid unjustified fear and anxiety: “I repeat that these are reactions considered mild and self-resolving, a small price to pay in the face of a significant health risk, at any age, due to illness. Let’s not fall into a defeatist approach that feeds doubts in the community and risks slowing down the vaccination campaign, a possibility to date of reaching a more civilized coexistence with this virus and resuming a new normality “. Viola adds: “It is good to remember that natural infections activate inflammation much more and can trigger autoimmunity phenomena. Better protect yourself with a vaccine “.
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