tetano
Editor, Senior Moderator
Br J Clin Pharmacol. 2011 Nov 15. doi: 10.1111/j.1365-2125.2011.04142.x. [Epub ahead of print]
Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes.
Mackenzie IS, Macdonald TM, Shakir S, Dryburgh M, Mantay BJ, McDonnell P, Layton D.
Source
Medicines Monitoring Unit (MEMO) Division of Medical Sciences University of Dundee Ninewells Hospital & Medical School Dundee DD1 9SY UK Drug Safety Research Unit (DSRU) Bursledon Hall Blundell Lane Southampton SO31 1AA UK.
Abstract
Objectives: During the global H1N1 influenza A (swine flu) pandemic 2009-2010, swine flu vaccines were expeditiously licensed and a mass vaccination programme for high risk groups including pregnant women was introduced in the UK. This pilot active safety surveillance study was performed to establish the feasibility of rapidly monitoring the new swine flu vaccines in large patient numbers receiving or offered the vaccination under normal conditions of use within a short time frame. Design: A cohort design with safety data capture through modern technologies Setting: Scotland, UK during the winter swine flu vaccination programme 2009-2010. Participants: Individuals receiving or offered the swine flu vaccination Main outcome measures: self-reported serious adverse events (SAEs) and pregnancy outcomes. Results: Cohort comprised 4,066 people; 3,754 vaccinated and 312 offered the vaccination but not vaccinated. There were 939 self-reported events (838 different events); 53 judged to fit SAE criteria by the investigators, with 9 judged as possibly, probably or definitely vaccine related. None of the 7 deaths (6 in vaccinees) were judged as vaccine related. 128 women reported 130 pregnancies during the study; 117 pregnant at study start. There were reports of 4 miscarriages in 3 women and 6 possible congenital abnormalities in live births. Conclusions: Overall, no significant safety issues were identified. The methodology and use of modern technologies to collect safety data from large numbers of patients was successful and could be used again in similar safety studies. What is already known about this subject: ▪ While the new H1N1 vaccines underwent the usual rigorous safety and efficacy testing, concerns remained that there may be unexpected side effects of the vaccines ▪ The strategy for H1N1 vaccine pharmacovigilance in the UK consisted of two patient studies by the two vaccine manufacturers, 14 small scale studies supported by the NIHR, monitoring by specialist neurologists and the MHRA. ▪ This pilot study was performed to investigate the feasibility of a large-scale prospective active surveillance system for near real-time vaccine safety monitoring that would be complementary to the other aforementioned initiatives.. What this study adds: ▪ This pilot study demonstrated that collecting 'near real-time' reporting of event data from patients who experienced side -effects as well as those who reported no problems after swine flu vaccination is feasible ▪ The use of information technologies improves patient involvement in research as well as dramatically limiting the cost of the study. ▪ The online methodology facilitates rapid surveillance in response to urgent safety issues.
? 2011 The Authors. British Journal of Clinical Pharmacology ? 2011 The British Pharmacological Society.
PMID:
22082196
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22082196
Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes.
Mackenzie IS, Macdonald TM, Shakir S, Dryburgh M, Mantay BJ, McDonnell P, Layton D.
Source
Medicines Monitoring Unit (MEMO) Division of Medical Sciences University of Dundee Ninewells Hospital & Medical School Dundee DD1 9SY UK Drug Safety Research Unit (DSRU) Bursledon Hall Blundell Lane Southampton SO31 1AA UK.
Abstract
Objectives: During the global H1N1 influenza A (swine flu) pandemic 2009-2010, swine flu vaccines were expeditiously licensed and a mass vaccination programme for high risk groups including pregnant women was introduced in the UK. This pilot active safety surveillance study was performed to establish the feasibility of rapidly monitoring the new swine flu vaccines in large patient numbers receiving or offered the vaccination under normal conditions of use within a short time frame. Design: A cohort design with safety data capture through modern technologies Setting: Scotland, UK during the winter swine flu vaccination programme 2009-2010. Participants: Individuals receiving or offered the swine flu vaccination Main outcome measures: self-reported serious adverse events (SAEs) and pregnancy outcomes. Results: Cohort comprised 4,066 people; 3,754 vaccinated and 312 offered the vaccination but not vaccinated. There were 939 self-reported events (838 different events); 53 judged to fit SAE criteria by the investigators, with 9 judged as possibly, probably or definitely vaccine related. None of the 7 deaths (6 in vaccinees) were judged as vaccine related. 128 women reported 130 pregnancies during the study; 117 pregnant at study start. There were reports of 4 miscarriages in 3 women and 6 possible congenital abnormalities in live births. Conclusions: Overall, no significant safety issues were identified. The methodology and use of modern technologies to collect safety data from large numbers of patients was successful and could be used again in similar safety studies. What is already known about this subject: ▪ While the new H1N1 vaccines underwent the usual rigorous safety and efficacy testing, concerns remained that there may be unexpected side effects of the vaccines ▪ The strategy for H1N1 vaccine pharmacovigilance in the UK consisted of two patient studies by the two vaccine manufacturers, 14 small scale studies supported by the NIHR, monitoring by specialist neurologists and the MHRA. ▪ This pilot study was performed to investigate the feasibility of a large-scale prospective active surveillance system for near real-time vaccine safety monitoring that would be complementary to the other aforementioned initiatives.. What this study adds: ▪ This pilot study demonstrated that collecting 'near real-time' reporting of event data from patients who experienced side -effects as well as those who reported no problems after swine flu vaccination is feasible ▪ The use of information technologies improves patient involvement in research as well as dramatically limiting the cost of the study. ▪ The online methodology facilitates rapid surveillance in response to urgent safety issues.
? 2011 The Authors. British Journal of Clinical Pharmacology ? 2011 The British Pharmacological Society.
PMID:
22082196
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/22082196