They have been about 20 million the doses of all types of vaccines administered in Italy in 2020, excluding products against Covid. Three million less than in 2019, a decline linked to reduced access to vaccinations, stress in healthcare facilities and other reasons that mix science and psychology in the first year of the Sars-CoV-2 pandemic. The 2020 Vaccine Report drawn up by Aifa explains that out of this total of administrations the adverse reactions reported were 17.9 every 100 thousand doses, with a rate of 606 reports per million inhabitants. Also in this case, of course, decreasing compared to the last few years. Of these, reports reporting serious vaccine-related reactions were 1.9 per 100 thousand doses.
The document, which describes the vaccine surveillance activities of the Italian Medicines Agency in collaboration with the Istituto Superiore di Sanità and the Working Group on the analysis of vaccine signals, underlines that “among the suspected adverse reactions observed in 2020 no undesirable events emerged that could modify the assessment of the relationship between benefit and risk of the vaccines used. All suspected adverse reactions observed, in fact, are known and therefore already reported in the product information of vaccines authorized in Italy. Furthermore, no groupings, temporal or geographic clusters of reports referable to specific batches were observed which have suggested potential defects in the quality of the medicinal product “. In short, everything under control, apart from the reduction in administrations compared to 2019. \
Source: ISS
Specifically, the reports entered in 2020 were 5,352 (12.9% of those surveyed by the National Pharmacovigilance Network which obviously also deals with drugs). Of these, 69% refer to suspected adverse events that occurred in 2020 while about 30% refer to previous years. The bulk was reported autonomously while a large part, almost 40%, is due to the active pharmacovigilance studies of the Regions carried out together with the AIFA. Of the reports the84.3% is classified as non-serious, 15.6 with serious events and in 0.1% indefinite. Unsurprisingly, the most frequent reactions are feverwith a rise in temperature up to 39.5 degrees centigrade, local reactions at the injection site or generalized skin reactions. All known and common effects as well as indicated in the characteristics of the different products used for hexavalent, tetravalent, trivalent, pneumococcal, anti-rotavirus, anti meningococcal vaccines and so on.
Among the less common events – but in any case known and already reported – reported by a doctor, pharmacist, healthcare professional or patient there were adverse reactions such as irritability, inconsolable crying (in the case of infants or children) e hyperpyrexia, i.e. fever above 39.5 degrees. Rarer, however, i.e. below 500 meters, are events such as hyporeactivity, diarrhea, nausea, vomiting, general pain, edema, headache and even disorders of the autonomic nervous system (vegetative reactions such as hypotension, lipothymia, sweating, etc.), asthenia, urticaria and itching, arthralgia, loss of appetite and febrile convulsions. Very few events, under 100, due to hypotonia or sleep disturbances. We are talking about 20 million administrations. Incidentally, in 95% of non-serious cases the reaction was obviously already resolved or in the process of being resolved at the time of the report. In 0.2% of the reports the reported outcome was death, but in none of the cases it was found to be correlated with vaccination.
Main adverse reactions reported in the latest Aifa Vaccine Report for 2020. Source ISS
71% of the reports concerned i children up to 11 years, age group in which most of the primary vaccinations and subsequent boosters fall (61.6% in the 1 month – 1 year age group), 3.7% adolescents, 19.4% adults and 5.9% over-65s. Among the vaccines with the most reports are those anti-meningococcal drugs (Men B, Men C, Men ACW135Y), indicated for primary immunization against invasive meningococcal infection caused by the serotype contained in the vaccine. In 2020, 2,475 reports of suspected adverse reaction to meningococcal vaccines were entered, down by 3.5% compared to 2019. 90.6% concern type B, 6.9% type ACW135Y, 2.1% type C.
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Source: Vanity Fair
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