Article

Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination.

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.
Vaccine (Impact Factor: 3.77). 03/2011; 29(20):3708-13. DOI: 10.1016/j.vaccine.2011.02.097
Source: PubMed

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, 1,162 (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.

0 Bookmarks
 · 
89 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Inactivated influenza vaccines have been given to pregnant women since 1964. Since 2004, the Advisory Committee on Immunization Practices has recommended that pregnant women receive trivalent inactivated influenza vaccine at any time during pregnancy. Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated influenza vaccine in mothers or their infants. During the 2009–2010 influenza A (H1N1) influenza vaccination program, several monitoring systems were established or enhanced to assess whether adverse events were associated with H1N1 2009 monovalent vaccines (2009 H1N1 influenza vaccines). Data from these systems did not identify any safety concerns in pregnant women who received 2009 H1N1 influenza vaccines or their infants. Although live attenuated influenza vaccines are not recommended in pregnant women, a small number of studies have not shown any safety concern among pregnant women or their infants who were inadvertently exposed to these vaccines. This review summarizes US and international safety data for influenza vaccines in pregnant women with an emphasis on 2009 H1N1 influenza vaccines.
    Expert Review of Vaccines 01/2014; 11(8). · 4.22 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: During influenza pandemics, pregnant women have an increased risk of severe complications. Vaccination can diminish these complications. In the Netherlands, the adjuvanted vaccines Focetria® and Pandemrix® were used during the A/H1N1 (2009) influenza pandemic. The national vaccination scheme included pregnant women, but knowledge concerning the safety of adjuvants during pregnancy was lacking. The aim of the study is to assess safety of adjuvanted influenza vaccines during pregnancy. The Dutch Teratology Information Service, part of the Netherlands Pharmacovigilance Centre Lareb, recruited 295 A/H1N1 (2009) vaccinated pregnant women through health care providers. Questionnaires were sent during the pregnancy to their health care providers and a second one 6 weeks after the estimated date of birth. Reported complications and adverse outcomes were compared with background rates. Additionally, the spontaneously reported pregnancy-related adverse reactions in the database of the Netherlands Pharmacovigilance Centre Lareb are described. Compared with the background rate, no increased risk of spontaneous abortions or congenital malformations was observed. There were three spontaneous abortions among 23 first trimester exposures. In the cohort of 281 pregnancies with known outcomes, three major malformations were observed after exposure at any time during pregnancy. In these cases exposure occurred once periconceptional, and twice in the second trimester. Furthermore, no increased risk of adverse pregnancy outcomes or neonatal problems were observed. The spontaneously reported pregnancy-related adverse events showed no unexpected pattern. The present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics. Birth Defects Research (Part A), 2014. © 2014 Wiley Periodicals, Inc.
    Birth Defects Research Part A Clinical and Molecular Teratology 04/2014; · 2.27 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: In recent times, there has been much interest in the development of pharmacological kinase inhibitors that treat NSCLC. Furthermore, treatment options have been guided by the development of a wide panel of synthetic small molecule kinase inhibitors. Most of the molecules developed belong to the type I class of inhibitors that target the ATP-binding site in its active conformation. The high sequence similarity in the ATP-binding site among members of the kinase families often results in low selectivity and additional toxicities. Also, second mutations in the ATP-binding site, such as threonine to methionine at position 790, have been described as a mechanism of resistance to ATP-competitive kinase inhibitors. For these reasons, alternative drug development approaches targeting sites other than the ATP cleft are being pursued. The class III or allosteric inhibitors, which bind outside the ATP-binding site, have been shown to negatively modulate kinase activity. Areas covered: In this review, the authors discuss the most well-characterised allosteric inhibitors that have reached clinical development in NSCLC. Expert opinion: Great progress has made in developing inhibitors with entirely new modes of action. That being said, it is important to highlight that despite their apparent simplicity, biochemical assays will remain at the core of drug discovery activities to better explore these new opportunities.
    Expert Opinion on Investigational Drugs 03/2014; · 4.74 Impact Factor