Adverse events associated with pandemic influenza vaccines: comparison of the results of a follow-up study with those coming from spontaneous reporting

Vaccine
A CarvajalJ Castrodeza

Abstract

Prior to marketing of pandemic influenza vaccines, the only safety data were those from clinical trials. The objective of this study was to compare information coming from spontaneous reporting with that systematically collected in a formal observation study; this also permits to further evaluate safety of pandemic influenza vaccines in the targeted patients' population. Out of a sample of 507 vaccinated subjects, 103 (20.3%) developed some complication. In the same period 83 reports corresponding to all vaccinated people of Castilla y León (n=131,462) were collected. Severe cases were 1 (1%) and 7 (8.4%), respectively, with the two procedures. The spontaneous reporting rate was 322-fold lower than that identified through the follow-up study; when considered the severe cases, it was 37-fold lower. Under certain circumstances reporting might be performing better than usual due to strengthening of the surveillance system. Adverse events observed for the pandemic H1N1 vaccines lie within the expected safety profile for common events with influenza vaccines. An overall benefit-risk assessment of these vaccines should be done.

References

Mar 19, 1999·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·E G BrownS Wood
May 13, 2009·Science·Christophe FraserWHO Rapid Pandemic Assessment Collaboration
Jun 3, 2009·Expert Review of Vaccines·Alexander Doroshenko, Scott A Halperin
Sep 12, 2009·The New England Journal of Medicine·Tristan W ClarkIain Stephenson
Sep 12, 2009·The New England Journal of Medicine·Michael E GreenbergRussell L Basser
Oct 23, 2009·The New England Journal of Medicine·Feng-Cai ZhuJing-Shan Zheng
Dec 19, 2009·Lancet·Dina PfeiferDavid Wood
Jun 18, 2010·Vaccine·Marc P GirardMarie Paule Kieny
Jul 10, 2010·AIDS·Pablo TebasCenter for AIDS Research and Clinical Trials Unit of the University of Pennsylvania

Citations

Oct 22, 2011·Medicina clínica·Mariano MadurgaDolores Montero
Aug 9, 2011·Vaccine·Leonoor WijnansMiriam Sturkenboom
Mar 11, 2011·Journal of Biopharmaceutical Statistics·Xiaoming LiIvan S F Chan
Oct 6, 2018·Chonnam Medical Journal·Lindsey BroussardPeter I Song

Related Concepts

Repeated Rounds of Survey
Influenza
Trivalent Live Attenuated Influenza Vaccine
Influenza A Virus, H1N1 Subtype
Clinical Trials
Complication
Influenza virus vaccine
Persons
Vaccines
Research Subject

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