The Italian Medicines Agency has published today on the institutional portal the Report on the Postmarketing Surveillance of Vaccines in Italy 2016, which describes the overall results of the analyzes conducted by type of vaccine on the reports entered in the National Pharmacovigilance Network in 2016.
“Even from the 2016 Report - says the General Manager, Mario Melazzini - there are no safety issues that can change the benefit-risk ratio of the vaccines used. As a regulatory agency, continuing with the transparency operation already started, we put in place and make available rigorous data and analyzes, in the face of a lot of disinformation on vaccines, supported by some opinion movements which, although representing a small percentage of the population, raise uproar and they generate doubts that are too often unfounded and unsupported by evidence. The 2017 data will be available in the first months of the new year ".
Unlike the previous ones, in which the analysis was conducted on the reactions that arose in the year under review, this year the Report examines all the suspected adverse reactions included in the National Pharmacovigilance Network in 2016, including those that arose in previous years. , in line with all the data made available by the Agency (OSMED report, RAM report). From the evaluation of the reports entered in 2016, no safety signals for authorized vaccines have emerged at the moment.
The reports on vaccines inserted in the 2016 network were 4.766 (11% of the total reports of drugs and vaccines). Of these, 3.256 reports (68%) refer to suspected adverse reactions that have occurred in the 2016.
The reports for bacterial vaccines were 2.977 (85,3% non-serious), and almost all refer to meningococcal (n. 1.713) and pneumococcal (n. 1.113) vaccines.
There were 1.602 reports for viral vaccines (80,8% non-serious), of which 74% related to influenza and morbid disease vaccines. There were 1.479 reports regarding bacterial and viral vaccines in combination (85,8% non-serious).
Overall, most of the reported reactions were defined as non-serious (approximately 84%). Among these, the most common were fever, injection site reactions (such as pain, redness, swelling, erythema), irritability, malaise, crying, headache.
Reports of suspected adverse reactions considered serious were rare and in most cases were transitory, with complete resolution of the reported event and not related to vaccination.
Of the seven fatal cases described in the 2016 Report, none were correlated with the vaccination among those for which the causal link could be assessed, while for the other two cases, in-depth studies were requested but not yet available at the time of publication of this Report.
It is recalled that the definition of “serious reaction” also includes hospitalization, the appearance of a clinically relevant event, regardless of the consequences for the patient, and the lack of efficacy of the vaccine.
The 37% of reports were received by specialists, about 28% from other professional figures (who do not fall into the other categories, such as vaccinating doctors), 20% from hospital doctors or nurses. The reporting rate in the North was higher than in the Center and South, except in the region of Sicily where one of the highest rates in Italy was observed.
In an overall picture in which there is a growing trend of drug reports, the trend in vaccine reporting, excluding the 2014-15 peak, remains constant.
It should be remembered that a high number of reports does not in itself constitute a cause for alarm, rather it is a testimony to greater attention and responsibility on the part of the signalman.
AIFA recommends the utmost care and completeness in the description of the reported cases in order to allow a complete analysis of the data and a correct assessment of the causal link between the reported event and the administration of the drug or vaccine.