adverse events in 29% of cases, in hospital 1 in 1800

adverse events in 29% of cases, in hospital 1 in 1800
adverse events in 29% of cases, in hospital 1 in 1800

The experts of the JCVI, the independent British medical-scientific committee that assists the government of Boris Johnson on the vaccination campaign, are right not to recommend the administration of vaccines to healthy children and young people between the ages of 12 and 15, urging greater caution on the report. risks / benefits, or the main scientific societies of pediatricians who instead recommend getting the vaccine in this age group? Beyond the cases of frail or immunosuppressed children who need to stimulate an antibody response to Covid, Italy is perhaps not receiving it in a hasty and imprudent way – compared to other States such as Great Britain, Israel, Germany or Denmark – l idea that vaccinating children and adolescents always, everywhere and in any case is a good thing? Are there official data, scientifically validated, published in authoritative scientific journals and as updated as possible that are worth taking into consideration?

The questions are anything but strange and the answers, marked by the utmost scientific rigor, cannot be listed, so simply and, as positions no vax. At least they require a supplement of reflection.

In Italy, as is well known, Aifa authorized on May 31, after the EMA’s green light three days earlier, the use of the Pfizer-BioNtech vaccine to immunize young people between 12 and 15 years of age from Covid. , triggering a change in the vaccination campaign on children and young people. Since then, the mantra “vaccinate, vaccinate, vaccinate” has somewhat abandoned its hold on the over 60s “escaped” from immunization. But if this strategy has shown, with significant statistical significance, to be extremely effective, at two months and six months, on adults in preventing severe disease, the transitive property on adolescents does not seem to be able to be applied automatically and with the same. safety standards, because no one knows the long-term results yet.

It should also be remembered that vaccines have so far obtained conditional authorization in Europe, not definitive approval. An authorization that remains conditional on the fact that phase 3 of the study produces the same efficacy and safety results over time until the final date on which the “design” of the trial says it must arrive (for Pfizer it is set for May 2023). The study, however, was conducted on the over 16s, but not on the under 16s, for whom the procedural trick of the so-called immunobridging: in practice, assuming that the pathology is similar to that of the adult population, yes it also pursues the primary objective of reducing the severity of the infection in adolescents.

But on children “the course of the infection is frequently asymptomatic” (study published in the British Medical Journal July 20, 2021) and even children between the ages of 12 and 16, when they become infected with Sars-CoV-2, are asymptomatic or have mild symptoms. Covid-19-related multi-systemic inflammatory syndrome has a modest incidence (~ 3 in 10,000 children in the US, where it mainly affects blacks, Hispanics and Asians) and it is unclear whether vaccines avoid it. The same incidence of the so-called Long-Covid seems to be in line with the course of other common viral diseases. Covid-19 therefore does not represent a danger for our young people who, on the contrary, if they fall ill, remain contagious for about a week and develop a lasting and beneficial immunity for all.

Pfizer’s study, for example, of 2,260 boys recorded only 18 cases of Covid in 6 months, of which none hospitalized, while that of Moderna, conducted on 12-15 year olds, counted 4 cases of Covid on 3,732 children, mostly asymptomatic and in a mild form.

However, there is not only this. From the United States there are “fresh” numbers that deserve attention on the pharmacovigilance front. The CDC, an important control body on public health, in fact published in August, in the V-safe program, a monitoring of the health status of 129,059 adolescents aged 12 to 17 years in the following 7 days inoculation of Pfizer-BioNTech’s anti-Covid vaccine. It is a digital system of “solicited surveillance” through which the families of the children are invited to report the appearance of any more or less serious adverse reactions.

Table 3 indicates the percentages of “immediate” adverse reactions / health impacts that emerged in the period 14 December 2020-16 July 2021. And what do the data, cumulative of the two doses, say?

The general data is that the onset of these adverse events increases, even a lot, after the second dose compared to the effects produced by the first. In the cluster 12-15 years old, the sample reported severe impacts on health in 11% of cases after the first dose and as much as 28.6% after the booster dose, while among 16-17 year-olds the same percentages respectively indicate 10. , 6% after the first dose and 25.4% after the second.

What adverse symptoms are we talking about? In the 12-15 year old class, always moving from the first to the second dose, the inability to carry out normal daily activities (for example, any effect that makes one unable to wear a shirt or to go up the stairs at home) hit 9% respectively and 24.7% of the sample; the inability to go to work or to be able to attend school, first affected 3.7% and then 11.7%; the need for medical care 0.5% and 0.6%; an intervention in telemedicine 0.1% and subsequently 0.2%; an outpatient visit after both doses 0.2%; the use of the emergency room 0.1% and after the booster dose 0.2%; hospitalization first 0.02% and then 0.03%.

In the 16-17 year old cluster, the same types of impacts on health indicate these percentages after the first and second inoculation: the inability to carry out normal daily activities goes from 9.3% to 23.1%; the inability to work or go to school from 2.4% to 6.1%, the need for medical care from 0.5% to 0.8%, telemedicine from 0.1% to 0.2%; the outpatient clinic from 0.2% to 0.3%; the visit to the emergency room from 0.1% to 0.2%; hospitalization from 0.02% to 0.04%.

Small numbers? Maybe, but if they are projected onto the entire Italian population of 12-17 year olds (3,414,410 adolescents, according to Istat) and assuming that everyone is vaccinated, this map of pharmacovigilance would result:

• 1,935 children hospitalized with serious health problems (~ 1 every 1,800);

• 10,244 children who will go to the emergency room (3 out of 1,000);

• 15,930 children who will resort to an outpatient visit (~ 4.7 per 1,000);

• 42,103 children who will need medical care (~ 12 per 1,000), plus another 10,244 who will have to resort to telemedicine interventions;

• 367,871 children who will not be able to go to school or work (~ 11 out of 100);

• 1,121,112 children who will be unable to carry out normal daily activities for one or more days (~ 33 out of 100).

In total, doing a simple arithmetic calculation, we would have about 80 thousand children who would need the National Health Service, from the need for medical treatment to hospitalization. Incidentally: according to the VIII Aifa Report on Covid vaccine safety, 91 thousand reports of adverse events were collected in Italy from December 2020 to August 2021, equal to 110 out of 100 thousand vaccines, i.e. hundreds of times less than the V- surveillance data. safe of the CDC.

In light of these projections (and considering that the cases of effects induced by the Moderna vaccine in adolescents are even worse than those of the Pfizer vaccine), science and politics cannot avoid some questions: our government is aware of these numbers ? And our family doctors? Are these numbers deemed acceptable by the authorities? How can it be argued that in childhood, the benefit / harm ratio is favorable to vaccination? Would the “sacrifice” of our children really protect the health of the entire community? How can youth vaccination be better than natural infection immunization, especially when the latter has been shown to offer over 10-20 times more robust and long-lasting protection for the Delta variant?

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