DÄ internationalArchive14/2009Vaccination Safety Update: In reply


Vaccination Safety Update: In reply

Dtsch Arztebl Int 2009; 106(14): 249. DOI: 10.3238/arztebl.2009.0249

Schneeweiß, B

LNSLNS Higher demands are made on the safety of vaccines than on medication used to treat serious disorders, because vaccines are usually used in healthy persons. We therefore wholeheartedly support Dr Klement's demand for well equipped and efficient monitoring systems in the interest of drug safety. Even in comprehensively tested vaccines it cannot be ruled out that very rare side effects will be observed for the first time once a vaccine has started to be widely used. It is therefore necessary to identify signs of possible side effects speedily and to investigate them reliably.

Of importance in this context are not only national efforts to improve pharmacovigilance but also cooperation among the EU authorities. A good example is the EudraVigilance database of the European Medicines Agency (EMEA; www.europa.emea.eu)). This contains one of the biggest side effect databases worldwide and is accessible for national authorities. The recently published EMEA recommendation, the "Guideline on the Conduct of Pharmacovigilance for Vaccines for Pre- and Postexposure Prophylaxis against Infectious Diseases" (http://www.emea.europa.eu/pdfs/human/phvwp/50344907en.pdf), for example, describes the requirements for pharmacovigilance of vaccines in the EU. Diverse WHO initiatives are also worth mentioning—such as the Global Advisory Committee on Vaccine Safety (GACVS; http://www.who.int/vaccine_safety/en/), which publishes evidence based assessments regarding perceived vaccination risks, and the attempts by the WHO/CIOMS working group to standardize pharmacovigilance of vaccines (http://www.cioms.ch/jan2008_current_programme_and_planned_activities.pdf).

Macrophagic fasciities, as mentioned by Dr Stenzel and colleagues, is one of the rare vaccination signs whose importance for systemic health impairment is unclear. In our limited overview we were able to discuss neither this, nor several other hypotheses, but we are in the process of preparing a separate publication on the subject.

One of the main objectives of our review article was to emphasize the need for doctors to notify any suspected vaccination related complication—this is central to pharmacovigilance. To detect signs early on, it is desirable that health impairments are also notified that may occur owing to a temporal, but possible not causal, association with the vaccination. DOI: 10.3238/arztebl.2009.0249

Prof. Dr. med. habil. Burkhard Schneeweiß
Karolinenhofweg 20
12527 Berlin, Germany

Conflict of interest statement
The author has received speaker honoraria and travel expenses from GlaxoSmith-Kline, SanofiPasteurMSD, and Wyeth
Schneeweiß B, Pfleiderer M, Keller-Stanislawski B: Vaccination Safety Update. [Impfsicherheit heute]. Dtsch Arztebl Int 2008; 105(34–35): 590–5. VOLLTEXT
1. Schneeweiß B, Pfleiderer M, Keller-Stanislawski B: Vaccination Safety Update. [Impfsicherheit heute]. Dtsch Arztebl Int 2008; 105(34–35): 590–5. VOLLTEXT