Adnkronos Rome, June 23 (Adnkronos Salute) – In 2023, reports of adverse events on vaccines decreased, "bringing levels to values below those recorded in the pre-pandemic period. In 2023, there was a marked reduction in reports from vaccines (-86,3%), which went from 31.652 to 4.330. Approximately 1 in 3 reports in 2023 concerned anti-Covid vaccines (28,3%, 1.224), for which the decrease compared to 2022 was equal to 94,2%.
Excluding from the analysis the reports containing anti-Covid vaccines as suspect vaccines, the reduction corresponds to 71,1%, with a total of reports from vaccines that goes from 10.967 in 2022 to 3.164 in 2023". This is highlighted in the 'Vaccine Report 2023' published by the Italian Medicines Agency (AIFA), which also takes stock of over 2 years of post-authorization monitoring of Covid vaccines. Data, numbers and detailed analyses tell of an Italy that is attentive, but without alarmism, capable of monitoring the proper functioning of the most impressive vaccination plan in recent history.
The reason for the drop in reports recorded? "First of all, the collapse in the number of doses administered: from over 52 million in 2022 to just over 25 million in 2023. But also the end of large active pharmacovigilance projects and the attenuation of media interest, which historically pushes up spontaneous reports for all vaccines", underlines the AIFA.
In 2023, "9 safety signals were opened on vaccines against Covid-19. All were examined by the Prac, the Risk Assessment Committee of the EMA, the European Medicines Agency. And all were closed favorably, that is, without any changes to the authorization or clinical indications of the vaccines involved - we read in the Aifa report - Before 2023, other safety signals evaluated by the EMA's Prac concluded by confirming the benefit-risk ratio in favor of the vaccine, highlighting however a correlation between the adverse events and its administration. This has already led to the inclusion of adverse effects in the package leaflet, as happens for any other drug. The related adverse events, but not to such an extent as to outweigh the benefits of vaccination for the general population, are: anaphylactic reaction, capillary leak syndrome, embolic and thrombotic events, erythema multiforme, heavy menstrual bleeding, immune thrombocytopenia, localized swelling in people with a history of dermal filler injections, myocarditis and pericarditis".
"Among the signals assessed by the Prac, but closed without modifying the package leaflets because the data were not sufficient to support a causal association, are: acute external macular retinopathy, amenorrhea, autoimmune hepatitis, corneal transplant rejection, glomerulonephritis and nephrotic syndrome, histiocytic necrotizing lymphadenitis, myositis, multisystem inflammatory syndrome, pemphigus and pemphigoid (bubbles on the upper and lower skin), postmenopausal haemorrhage, vulvar ulceration," the report lists.
"It is important to remember - AIFA points out - that making a report does not mean having certainty of a cause-effect relationship, which depends on many other factors, including: the temporal association between vaccination and the adverse event must also be biologically plausible (for example, if a tumor is diagnosed 3 days after the administration of a vaccine, it is unlikely that the responsibility is attributable to vaccination); the frequency with which that event occurs in the general population, regardless of vaccination; and also the presence of other possible causes, such as pre-existing diseases and medications taken".
In 2023, the report continues, "there were 572 reports with at least one serious event associated with anti-Covid vaccines, equal to 46,7% of the total reports on these vaccines. But be careful: this does not mean that the vaccine caused the event. It only means that, in those cases, the reported event had a significant clinical impact (hospitalization, risk to life, temporary or permanent disability). In reality - it is pointed out - only 182 reports out of 1.224 concerned adverse events that arose in 2023. The others (over 1.000) were retroactive, that is, reports referring to previous years. And it is precisely among these that the most serious events are concentrated: an understandable logic, since the milder reactions are often overlooked or forgotten over time, while the serious ones tend to push users to report even months later".
In relation to the outcome, "in 49% of the adverse events there was a complete resolution or improvement. For 31,4% the outcome at the time of reporting was considered unresolved, for 7,8% resolved with sequelae and for 2,6% the reported outcome was the death of the patient. Those following the administration of the anti-Covid vaccines alone were 36, while 2 were cases of co-administration of the anti-Covid and flu vaccines. This does not mean, however, in any case - specifies the AIFA - that a causal link was found between the administration of the vaccine and the death. In 11 cases, in fact, essential information for the evaluation was missing, in others the evidence did not support any causal association with the vaccine. In 7 cases these were patients with a complex clinical picture, with the coexistence of important diseases, while for another 7 cases the death occurred many months after the administration of the vaccine, a fact that does not suggest any temporal correlation with the last one. administration. In another case, it was the report of the family's medical examiner that ruled out any connection between the vaccination and the death, most likely resulting from a suspected encephalitis that was not promptly diagnosed. A final case involved an elderly patient, who suffered anaphylactic shock a few minutes after the administration of the fourth dose of the vaccine".
The reporting rate of serious events from anti-Covid vaccines "was 2,5 per 100.000 doses. For comparison: the rate of hospitalization from Covid in 2023 was 140 per 100.000 inhabitants. The risk of the disease remained largely higher than that of the vaccine - the report highlights - Compared to the reports regarding all other vaccines, for anti-Covid vaccines there is a lower proportion of those sent by doctors (30,4%) and especially by other health workers (8,9%), while there is a significant percentage of reporting by citizens, equal to 45,4%".
The report then goes into detail about the 9 signals closed in 2023. "The first concerned vulvar ulceration in association with Pfizer's Comirnaty mRNA vaccine; the next 3 safety signals concerned pemphigus and pemphigoid, autoimmune diseases characterized by the formation of blisters on the surface of the skin in the first case and under the skin in the second. The cases were associated with the Astra Zeneca viral vector vaccines Vaxzevria, Moderna's Comirnaty and Spikevax mRNA vaccines; the fifth, sixth and seventh signals concerned the Vaxzevria, Comirnaty and Spikevax vaccines associated with myositis, a muscle inflammation that can be caused by various factors including infections, autoimmune conditions and drug intake; the eighth and ninth signals concerned postmenopausal hemorrhages associated with Comirnaty and Spikevax vaccines."
In all cases, "sufficient evidence has never emerged to establish a causal link between the vaccine and the adverse events reported, and a threshold of evidence has never been reached that calls into question the overall safety of the vaccine. No signal has required the recall of batches, the modification of the therapeutic indications, or the interruption of administration."