Aifa: first data on adverse events of covid-19 vaccines

Aifa: first data on adverse events of covid-19 vaccines
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Aifa has published a press release, dated 4 February 2021, indicating its evaluations on the reports received of adverse events to the anti-Covid19 vaccines Pfizer and Moderna (the only ones administered for a sufficiently long period to provide them).

AIFA press release 628

According to the law, "7.337 reports were received out of a total of 1.564.090 doses administered (reporting rate of 469 per 100.000 doses), of which 92,4% refer to non-serious events" while "7,6 % of reports classified as "serious" (corresponding to 557 serious cases NDR) for which the causal link with vaccines is being assessed, three out of four did not require specific intervention in the hospital setting. In the period, 13 were also reported deaths occurred in the hours following vaccination "...

We specify that the period under consideration is one month, from December 27, 2020 to January 26, 2021, and that the data refer almost exclusively to the Pfizer vaccine (Comirnaty) as the Moderna entered Italian distribution only on January 14th. Now Astrazeneca (Oxford vaccine) has also arrived, which is reserved for under 55s and of which we will presumably see the data in a month or in any case in the next updates.

It should be noted that they are not carrying out any active pharmacovigilance projects: the reports are spontaneous or reported by health professionals / doctors. There is therefore no research and those who are vaccinated are not actively contacted to assess their state of health. On the other hand we have confirmation from the news of these days, that those who get vaccinated are frequently forced to take time off from work due to fever and / or pain of various kinds and intensity. In our opinion, this is a serious flaw in this "survey" which also invalidates its validity: Aifa in fact comes to the conclusion that "The analyzes conducted on the data acquired so far therefore confirm a good safety profile of these two mRNA vaccines. L The large number of reports does not imply that unexpected criticalities have emerged, but it is an indication of the high capacity of the pharmacovigilance system to monitor safety. "
But how is it possible to define an experimental (or even just "new") product safe without carrying out investigations worthy of the name on the clinical consequences of its use?
We read on the website of the Istituto Superiore di Sanità: "With regard to active vaccinovigilance, these are projects that allow the collection of suspected Aefi, encouraging and facilitating reports by health professionals in specific situations (for example for new vaccines or for limited periods of time). "
So why in this case is it not considered necessary (if not essential) the accurate detection, research and management of suspected or confirmed adverse events? I guess the answer is the same for all the questions these days: too much haste, we are in an emergency.


From England, on the other hand, we receive different and above all rapidly increasing data:
Pfizer: from 9/12/20 to 24/1/21 49472 adverse reactions of which 107 deaths. After 6 days: 59614 143 and XNUMX deaths.
AstraZeneca: from 4/1/21 to 24/1/21 21032 adverse reactions of which 32 deaths. After 6 days: 42649 and 90 deaths. + 8 abortions

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We will continue to update and publish trying to keep up with the new data - and with the new vaccines.