The AIFA report on vaccines? 188 pages not to mention the essentials
It came out on July 26 relationship that Aifa dedicates to the pharmacovigilance of vaccines. The file-moreover ready from June 25 (!)- collects data from 2022. Needless to ask why it is not up to date: despite the fact that public bodies have sophisticated computers and even AI to manage databases, every year Aifa accumulates months and months of delay before their disclosure.
The report on 2017 saw the light six months later, that of 2019, 12 months. This released now refers to 2022, therefore, presents the reports of 18 months ago.
Are there data on Covid vaccinations? Nope.
Why is that?
In early March 2023, the latest update on Covid vaccines came out, on that occasion Aifa warned that from then on there would be no more distinctions between those vaccines and all the others, so data on Covid ones would also be included in a common report annually.
The result is: while before the updates were disclosed within the three months following the period under review (e.g. the data for the year 2022 came out in March 2023), now the data of the anti Covid vaccines for the year 2023 will be public in July 2025, when the general attention has waned.
What would be useful to know today? The benefit-risk ratio of mRNA vaccines given that some European countries have already purchased the packages for the next pandemic, the new Avian, given for safe even if officially no “species jump ” has yet occurred in humans (therefore the new antidotes have not been tested on any disease).
Let’s get to the report
The premise is reassuring:
“Reports of suspected adverse reactions confirm that the use of vaccines had a favorable benefit-risk ratio, with the absence of risk signals in Italy. In this regard, the annual incidence of reports in 2022 was 47.8 reports per 100,000 doses administered, a value that drops to 2.8 per 100,000 doses in the case of reports with at least one serious event. The deaths out of 19 million vaccinations were 7, 0.1% of suspected cases reported but for no one has been established a causal link that can attribute the responsibility for the death to the vaccine”.
On page 19 we read that “the main objective of Vaccine vigilance is to understand whether or not a certain adverse event is related to the administration of a vaccine that occurred previously”.
But then, surprisingly – and unlike in past years- in this report Aifa did not assess any causation except in six out of 10,967 cases!
The vaccination-adverse event report is not considered by Aifa for any other of the reports received. Fevers, seizures, Bell’s palsy, Guillam Barre’s syndromes, seven deaths or deaths resulting from 19 million doses are to be considered only “suspected reactions”.
On the contrary, as you can see from the accompanying slide, Figure 13, in the 2017 hexavalent vaccine report, Aifa was able to establish the causal link (72% of the reports were rated “correlable”).
What happened in 2022 differently?
Mystery. Aifa gives no explanation. Yet a clarification on this would be relevant to the stated intent of the report.
The slide with the considerations was made by the infectionist Fabio Franchi. Which reminds us that until 2015 the Aifa reports did not examine the cause and effect nexus, introduced from 2016 to 2021, but that is now forgotten again. “It is better to leave all events in the limbo of suspicions, it is a more comfortable choice to manage for those who want to defend vaccines to the bitter end”.
It would be an important point to clarify in view of the upcoming amendments to change the Lorenzin Law that the League has anticipated to propose to parliament.
Another interesting chapter is the one about the active pharmacovigilance (which is the adverse event detection system that involves the active involvement of family members, required to keep a diary to record any ailment or malaise that occurs in the weeks following vaccination. Passive surveillance, on the other hand, is based only on spontaneous statements).
Beware of percentages. Aifa points out that 80% of the reports reported in the report derive from active surveillance; “but we also know that those studies concern very small percentages – recalled Franchi – Are research carried out, presumably, on less than 1% of the population. Aifa, again, does not provide the exact numbers that would allow to do some calculation preciso.Il report reports 4, what is surprising is that none of these is known what has emerged”.
That’s right. Studies are presented but no data appear!
On page 93 et seq we find that sample active pharmacovigilance studies have been done on:
1) Vaccination against meningococcal B (Besero
Results? Not reported.
2) Promotion of vaccine activities-supervision at the ASL of Caserta. The project funded by the Campania Region has constituted “a network of health professionals (doctors, nurses) trained, sensitized and motivated on Vaccinovigilance, able to recognize and report suspected adverse reactions associated with the use of vaccines”.
Results? Not reported.
3)” Surveillance of adverse events after vaccination in pregnancy”: multiregional project with the Puglia Region (leader) and Campania as an adherent region, whose objective is to acquire efficacy and safety data of influenza and anti-diphtheria – tetanus-pertussis vaccines in pregnancy through the compilation of a vaccination diary and the performance of telephone interviews of follo up The project also provided for the realization of training and awareness-raising activities of the operators of the birth path on the issues of safety and surveillance of adverse events in the vaccination field”.
Results? Not reported.
4) “Vigifarmacova:: surveillance on adverse reactions from vaccines”: project of multiregional dimension, with the Veneto Region as leader and the participation of n. 11 Italian regions (Abruzzo, Calabria, Campania, Emilia-Romagna, Friuli-Venezia Giulia, Liguria, Lombardy, Marche, Molise, Piedmont, Tuscany). It is an active surveillance of children subject to vaccination in the first two years of life, with the primary objective of increasing parental involvement in Vaccinovigilance. The study involves parents being asked, via SMS, to provide guidance on any adverse events arising after vaccination. The use of an IT platform (called Vigifarmacovax
Results? Not reported.
It’s not over. As you can see from the second table attached there is an obvious unevenness in reporting between regions up to 194 times between the most “virtuous” and the least.
In Val D’Aosta the reporting rate of adverse events is 0.8 per 100,000 inhabitants; in Piedmont it rises to 83.2 per 100,000; in Friuli Venezia Giulia it is the maximum reported among all regions, 155.6.
Aifa does not explain the reason for these differences. Franks reflects: “We wonder if these differences can be considered reliable and how undeclared the undeclared is. Aifa does not wonder what they depend on, yet it is a signal that the detection system is not working. We discuss unreal data”.
Not only that. “Aifa has mentioned the phenomenon of’ under notification ‘ and has not quantified it – the infectionist has specified-Yet it is possible to do it and it has been done: the report OER Puglia (we talked about it here) compared the percentage of reports between active and passive surveillance for the quadrivalent Mrpv vaccine. The degree of under notification was in the order of many hundreds of times for serious events. The numbers they discuss are 500 times less than the royals!”
Moral: the dedicated report came out a year and a half late, it lacks pharmacovigilance on COVID, it does not report any cause and effect link between vaccinations and adverse events (the latter was even indicated as the main purpose of the work), it lists 4 studies of active pharmacovigilance (which alone absorb 80% of the reports although covering only 1% of the population) but does not even report a result, it is counted among the publications of scientific value yet it is content to observe gigantic discrepancies in the reports between regions (without providing explanations) and share among the “not classifiable” for lack of data. All the illnesses, serious or light, that followed the 19 million vaccinations are only “suspicious”.
Yeah, the usual suspects. Pharmaceutical companies thank you.
Original source: https://blog.ilgiornale.it/locati/2024/08/02/il-rapporto-aifa-sui-vaccini-188-pagine-per-non-dire-lessenziale/
