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Volume 5, Issue 7 (Suppl) J Infect Dis Ther, an open access journal
ISSN: 2332-0877 Infection Prevention 2017
December 14-15, 2017
December 14-15, 2017 | Rome, Italy
13th World Congress on
INFECTION PREVENTION AND CONTROL
Adverse events following immunization with a meningococcal serogroup B vaccine: Report from a
German passive surveillance system
Doris Oberle, Dirk Mentzer and Brigitte Keller-Stanislawski
Paul-Ehrlich-Institut, Germany
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 immunization (AEFI) reported from Germany since launch on the European market
through December 2016 were reviewed and analyzed.
Results: Through December 2016, a total of 664 individual case safety reports (ICSR) notifying 1960 AEFI were received.
A majority of vaccines were children aged two 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.
Biography
Doris Oberle is a Physician and Biostatistician at the pharmacovigilance department of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines,
Langen, Germany. Her research focuses on the investigation of adverse events following immunization. For example, within the scope of a case-control study, she
investigated the association between pandemic influenza A (H1N1) vaccination and narcolepsy in Germany. She is also involved in the detection and evaluation of
safety signals especially regarding newly approved pharmaceutical products like the meningococcal B vaccine.
Doris Oberle et al., J Infect Dis Ther 2017, 5:7(Suppl)
DOI: 10.4172/2332-0877-C1-035