Covid vaccine on children: data is missing for an adequate risk/benefit analysis

Covid vaccine on children: data is missing for an adequate risk/benefit analysis
Covid vaccine on children: data is missing for an adequate risk/benefit analysis

by Sara Gandini and Maurizio Rainisio

In 2020, the number of deaths among children and young people aged between 5 and 14 considering all causes, not just Covid-19, was 360: 49 less than expected calculated compared to the previous nine years (2011-2019) ; in 2021 there were 381 deaths, 22 fewer than expected; in 2022 there were 382 deaths, 15 fewer than expected. In 2023 we had 438 deaths, 47 more than expected. Substantially we note a significant defect in deaths in the years in which the epidemic was greater virulent, while an excess is seen in 2023 when the epidemic seemed to be coming to an end. It seems paradoxical and yet no one talks about it.

Some have noted that the mortality flaw could be attributed to risk arising from road accidents decreased during the lockdown. However, Istat data on the causes of deaths do not indicate any increase in deaths from road accidents in the 5-14 age group in the years of the epidemic compared to previous years.

Among those aged 6 to 12 there were 3 deaths attributed to Covid-19 in 2020 (1 in 1.2 million), 5 in 2021 (1 in 0.74 million), 9 in 2022 (1 in 0.41 million) , and none in 2023. Such small numbers would have allowed for an examination extremely accurate of clinical cases to verify whether Covid was actually the cause of death, because they most likely concern subjects with various concomitant pathologies. This was done in England and Wales, where theOffice for National Statistics distinguishes between deaths involving Covid And due to Covid. The former, more or less, are in agreement with the Italian ones.

It is also interesting to note that in the USA social inequalities and the lack of a national healthcare system like the Italian one have an impact remarkable also on pediatric mortality: from August 2021 to July 2022, the deaths attributed to Covid in children aged 5-9 years were 4/million and in children aged 10-14 years 5/million, twice compared to Italy.

There are approximately 3.6 million children aged 5-11 years. For the period before March 2022, in which 2.4 million doses were administered, no separate mortality/morbidity data are available for children with or without vaccine, 1.3 and 2.3 million respectively; ISS instead announced them for the following period until January 2023. In this period, a further approximately 0.3 million doses were administered, reducing the number of children without vaccines by 75 thousand units and increasing the number of children vaccinated with two doses. Among vaccinated children, no deaths occurred during this period, while there were 8 deaths among children Not vaccinated.

Based on this very limited data (one twentieth of the total number of vaccinated children), an estimate could be made which would indicate that without the vaccine there would have been 4 more deaths; on the contrary, assuming that all children were vaccinated with an additional 4.5 million doses, we could estimate 8 fewer deaths. To make this estimate reasonably precise it would be appropriate for the health authority made public data similar to those concerning the previous period in which approximately 2.4 million doses of vaccine were administered to 1.3 million children.

We have no way to estimate how many adverse events there would have been among the 2.3 million unvaccinated children if they had been vaccinated. Serious adverse events are estimated to be rare, but we do not yet know how rare, nor their course; in fact even the most recent meta-analyses declare that information is missing on this type of event. It is not clear why manufacturing companies were not required to carry out this procedure active pharmacovigilance because this would have allowed us to understand something more about the safety of vaccines. This, combined with the limited data on mortality with and without vaccine, does not allow us to carry out an adequate risk/benefit analysis of vaccination in this population.

Data sources:

The data made available is invariably in aggregate form and with variable age groupings. As far as possible we tried to stay within the pediatric ages. There are notable discrepancies between the ISS data and those of the Ministry of Health on the number of vaccines administered, but they are not such as to influence the conclusions and data on deaths from traffic accidents until 2021.

ISTAT provides data for the size of the population by single age and for deaths from all causes aggregated for age groups 0.1-4, and then five in five years.

ISS through INFN provides data for deaths attributed to Covid. Aggregated data for age groups 0-5, 6-12, 13-19, and then ten after ten years.

The ISS weekly bulletins from 16 March 22 to 18 January 23 provide data on the effect of vaccines aggregated by age groups 5-11, 12-39, 40-59, 60-79, 80 or older.

The Ministry of Health database – Covid-19 Opendata Vaccini provides aggregate data in age classes 5-11, 12-19, and then ten by ten years on the administration of vaccines.

 
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