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doi:10.1016/j.vaccine.2011.02.097 | How to Cite or Link Using DOI
Copyright © 2011 Published by Elsevier Ltd.
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Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination
Elisabetta Parrettaa, Corresponding Author Contact Information, E-mail The Corresponding Author, Benedetta Iannielloa, Fernanda Ferrazinb, Francesco Rossia and Annalisa Capuanoa
a Regional Center for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Faculty of Medicine and Surgery, Second University of Naples, Via De Crecchio, 7, 80138 Naples, Italy
b Italian Medicines Agency, Section of Pharmacovigilance, Via del Tritone, 181, 00187 Rome, Italy
Received 1 September 2010;
revised 14 February 2011;
accepted 28 February 2011.
Available online 12 March 2011.
Abstract
According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1162 (87.37%
AE reports were classified ‘non serious’, 91 (6.84%) ‘serious’, 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries.
Copyright © 2011 Published by Elsevier Ltd.
Permissions & Reprints
Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination
Elisabetta Parrettaa, Corresponding Author Contact Information, E-mail The Corresponding Author, Benedetta Iannielloa, Fernanda Ferrazinb, Francesco Rossia and Annalisa Capuanoa
a Regional Center for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, Faculty of Medicine and Surgery, Second University of Naples, Via De Crecchio, 7, 80138 Naples, Italy
b Italian Medicines Agency, Section of Pharmacovigilance, Via del Tritone, 181, 00187 Rome, Italy
Received 1 September 2010;
revised 14 February 2011;
accepted 28 February 2011.
Available online 12 March 2011.
Abstract
According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy for prophylaxis of the A/H1N1 (2009) pandemic influenza. From October 2009 to June 2010, the Italian Pharmacovigilance Adverse Event (AE) Spontaneous Reporting System [Rete Nazionale Farmacovigilanza] (RNF) received 1330 reports of AEs temporally related with the pandemic influenza vaccination out of a total of 924,057 doses administered. Among these, 1162 (87.37%
AE reports were classified ‘non serious’, 91 (6.84%) ‘serious’, 3 (0.23%) had a fatal outcome and 74 (5.56%) did not include the degree of seriousness. Among the serious AE reports, some unexpected AEs emerged. Even though some typical vaccine safety issues which emerged should be further explored, such as vaccination in pregnancy, the analysis of all AE reports sent to RNF shows that the vaccine has a well-tolerated safety profile which resembles that of the already available seasonal influenza vaccines. This contrasts with the widespread public concern about its safety, which has been one of the major causes of the low vaccination rate observed in Italy, as well as in other countries.