The Reports of suspected adverse reactions to vaccines are down 39%. No causal link established for the deathsi. The highest reporting rates of suspected adverse reactions to vaccines were recorded, in 2022 as had already occurred in 2021, for the anti-meningococcus C and anti-meningococcus B vaccines. If only reports with serious events are considered, the highest rate was observed for the Mpr (measles, mumps and rubella), Mpr-V (the 3 plus the anti-varicella) and anti-meningococcus C vaccines, although to a significantly lower extent than in 2021. This is what emerges from the 2022 Vaccine Report published by the Italian Medicines Agency (AIFA), in collaboration with the Istituto Superiore di Sanità and the Vaccine Vigilance Working Group composed of the Regional Pharmacovigilance Centers, representatives of the Prevention Offices of the Regions and the Ministry of Health.
The cause-effect assessment is complex, however, the report specifies. Establishing this ‘responsibility’, which in technical language is called causal link, causal relationship or cause-effect relationship, is not at all simple. It is a rather complex procedure, which evaluates the case from both a clinical and pharmacological point of view, also in relation to the data available from scientific literature and other reliable sources. In fact, it is not enough for the event to occur after vaccination, but other possibilities must also be considered. First of all, the time span between vaccination and the first symptoms of the event must be adequate from a ‘biological’ point of view. For example, if 3 days after the administration of a vaccine a patient is diagnosed with a tumor, it is unlikely that the vaccine has any responsibility, because the tumor requires a much longer ‘biological’ time to develop and be identified in the analyses. Similarly, an allergic reaction experienced one year after vaccination is not attributable to the vaccine, because allergic reactions can occur at most a few days or weeks after vaccination itself.
Simple examples to understand, although in most cases more complex and previously undescribed events must be evaluated. In any case, vaccination is almost never the only possible cause. In fact, the vaccinated person’s illnesses and the medications they are taking must also be considered. For example, if a person with cardiovascular disease is vaccinated and has a stroke in the following month, the cardiovascular disease will be a more likely cause of the stroke than the vaccine. Furthermore, reports often do not include fundamental information to define the responsibility of a vaccine in causing an event. Establishing a correlation between vaccination and an adverse event is a process that always leaves room for uncertainty, which remains even when using algorithms that support those responsible for the evaluation.
Suspected adverse events
In general, the reports of possible side effects confirm that the benefit-risk ratio is in full favor of the authorized products, with incidence rates of 0.048% for all administrations, which drops to 0.003% in cases with at least one serious event. Furthermore, no safety alerts with a potential negative impact on the benefit-risk ratio of the authorized vaccines have occurred.
Excluding anti-Covid vaccines, which are the subject of other publications, in 2022 approximately 19 million doses were administered in Italythe report states. Of these, 10,967 reports were entered into the National Pharmacovigilance Network, of which 9,077 referred to suspected adverse reactions that actually occurred in 2022, with a rate of 47.8 reports per 100,000 doses administered, equal to 0.048% of cases. This figure is down 39% compared to the reports of the previous year. 93.5% of the reports concerned exclusively non-serious adverse events that affected 5 anatomical systems or apparatuses: general alterations and conditions relating to the site of administration, especially fever, local reactions at the injection site and crying; irritability, nervousness and restlessness; alterations of the gastrointestinal system, especially with diarrhea, vomiting and stomach ache and abdominal pain; alterations of the skin and subcutaneous tissue, in particular generalized skin reactions, morbilliform rash and urticaria; drowsiness, headache and febrile convulsions. At the time of reporting, 78% of the suspected adverse events had resolved without any consequences for the person, in 10% of the cases the outcome had not been reported, in 8% the vaccinated person was improving, 3% had not yet recovered and 0.7% were in the recovery phase with sequelae.
Considering reports with at least one serious event, the reporting rate drops to 2.8 per 100,000 doses administered, equal to 0.003% of administrations. Cases with events requiring hospitalization are 1.6%, while deaths out of 19 million vaccinations were 7, 0.1% of the suspected cases reported, but for none of them has a causal link been established that could attribute the vaccine’s responsibility for the death.
Of the 7 fatal casesthe vaccines indicated as suspect were in one case the quadrivalent against measles, mumps, rubella and chickenpox and in 6 cases the flu vaccine, in 3 reports administered together with the anti-Covid. In no case did the available information allow the cause of death to be identified in the vaccine.
The 3 cases of vaccination with only the influenza vaccine indicated as suspicious involved elderly patients, with an average of 86.3 years, complex clinical pictures and multiple pathologies; in no case did the available information allow the cause of death to be identified in the vaccine. The remaining 3 cases of influenza vaccine co-administered with the anti-Covid vaccine always involved patients with complex clinical pictures and multiple pathologies, aged 63, 80 and 92; in no case did the available information allow the cause of death to be identified in the vaccine. The single case with the quadrivalent vaccine involved a 2-year-old patient, affected by multiple pathologies, whose death, as also reported by the medical-legal report, was not related to the vaccination, but to the pre-existing pathological condition.
At European level only in 2 cases safety assessment in 2022
Vaccines they are therefore confirmed to be highly safe products. At the European level, there are only 2 safety issues that have required specific investigation in one year. In fact, during 2022, there are 2 safety signals regarding vaccines that have been submitted for evaluation by the Prac, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA).
Specifically, the report states, one safety signal concerned extensive swelling of the limb after administration of the 23-valent unconjugated pneumococcal vaccine and resulted in a recommendation to update the product information.
The other signal concerned immune thrombocytopenia (a lack of platelets in the blood that causes often mild bleeding) after the administration of the tetravalent vaccine against diphtheria, tetanus, pertussis and polio. But since the available data were not sufficient to support a hypothesis of a causal relationship between vaccination and the pathology, no regulatory action was recommended by the Prac, other than routine monitoring.
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