Doris Oberle
Paul-Ehrlich-Institut
Federal Institute for Vaccines and Biomedicines
Germany
Title: Adverse events following immunisation with a meningococcal serogroup B vaccine: report from a German passive surveillance system
Biography
Biography: Doris Oberle
Abstract
Background
Invasive meningococcal disease (IMD) can be fatal and may lead to permanent neurological sequelae and disabilities. In January 2013, a novel vaccine against Neisseria meningitis serogroup B, 4CMenB, was approved by the European Medicines Agency. We aimed at evaluating the safety profile of this vaccine.
Methods
All adverse events following immunisation (AEFI) reported from Germany since launch on the European market through December 2016 were reviewed and analysed.
Results
Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1960 AEFI were received. A majority of vaccinees were children aged 2 to 11 years (n=280, 42.2%) as well as infants and toddlers aged 28 days to 23 months (n=170, 25.6%). General disorders and administrations site conditions was the system organ class (SOC) with the majority of AEFI (n=977, 49.8%) followed by the SOCs nervous system disorders (n=249, 12.7%) and skin and subcutaneous tissue disorders (n=191, 9.7%). Screening for immune-mediated and neurological diseases did not raise any safety signal in terms of an increased proportional reporting ratio (PRR).
Conclusions
The safety profile described in the summary of product characteristics, in general, is confirmed by data from spontaneous reporting. No safety concerns were identified.