The Italian Medicines Agency has published the annual report on the safety of COVID-19 vaccines. The data collected and analyzed concern the reports of suspected adverse reactions registered in the National Pharmacovigilance Network (RNF) in the vaccination campaign year from 27 December 2020 to 26 December 2021 for the four vaccines in use in the current vaccination campaign.
In the period considered, 117.920 reports were received out of a total of 108.530.987 doses administered (reporting rate of 109 per 100.000 doses), of which 83,7% (98.717) referred to non-serious events, such as pain in injection site, fever, asthenia / fatigue, body aches.
Serious reports correspond to 16,2% of the total (19.055), with a rate of 17,6 serious events per 100.000 doses administered. As reported in previous Reports, regardless of the vaccine, dose and type of event, the reaction occurred in most cases (approximately 73%) on the same day as vaccination or the next day and only more rarely beyond 48 hours. .
In the vaccination campaign year, Comirnaty was the most used vaccine in Italy (69,1%), followed by Spikevax (18,3%), Vaxzevria (11,2%), and COVID-19 Janssen vaccine (1,4 %). The reports by type of vaccine are instead distributed as follows: Comirnaty 68%, Vaxzevria 19,8%, Spikevax 10,8%, Vaccine COVID-19 Janssen 1,4%.
For all vaccines, the most reported adverse events, mostly non-serious and already resolved at the time of reporting, are fever, fatigue, headache, muscle / joint pain, injection site pain, chills and nausea. It should be noted that in the pivotal studies up to 64% of undesirable effects were detected in the placebo group and are attributable to the so-called nocebo effect.
As regards the administration of the third dose, which began in September, as of December 26, 2021, 3.510 reports were included in the RNF, compared to 16.198.231 of third doses administered, with a reporting rate of 21,7 reports per 100.000 third doses, lower than that observed for primary cycle doses. 84,1% (2.951) of reports related to non-serious events, with a reporting rate of 18,2 per 100.000 doses administered, and 15,9% (558) to serious adverse events, with a rate of 3,4 reports of serious events per 100.000 doses administered.
730 reports were received after heterologous vaccinations, involving the use of 2 different COVID-19 vaccines for primary vaccination cycles (heterologous primary vaccination) or for booster doses 3-6 months after the primary vaccination course (heterologous booster ). Most of the reports after heterologous vaccination are related to the administration of an mRNA vaccine after the first administration of an adenoviral vector vaccine, are for the most part not serious and have the same characteristics as the rest of the reports.
With regard to vaccinations in pediatric age (5-16 years), as of 26/12/2021 4.178.361 doses of vaccine were administered, 96% of which in the age group 12-16 years (4.005.471 doses) and 4% in the 5-11 year range (172.890 doses). Of the two vaccines authorized for this population, Comirnaty was the most used (87,5%) (Spikevax 12,5%). As of December 26, 2021, a total of 1.170 reports of suspected adverse reactions occurring in the pediatric population were recorded in the RNF, representing 1% of all reports, with a reporting rate of 28 events per 100.000 doses administered in the pediatric range, regardless the type of vaccine and the assessment of the causal link, therefore lower than that found in the general population (109 events per 100.000 doses administered). In the pediatric population, the most frequently reported adverse events are fever, headache, fatigue and vomiting. 69% of reactions resolved completely or were improving at the time of reporting. Reporting rates in the 5-11 age group are preliminary and no particular safety concerns are currently emerging.
Vaccination for COVID-19 is indicated in both pregnancy and lactation and no particular safety problems emerge from pharmacovigilance data and ad hoc studies in this population. There is also no evidence to suggest that COVID-19 vaccines can adversely affect fertility in either sex.
The other insights presented in the Report, on events of particular interest such as anaphylaxis, Guillain-Barré syndrome, myocarditis / pericarditis, Bell's palsy and thrombocytopenic thrombosis confirm the safety data evaluated at European level.