Influenza H1N1 (swine flu) vaccination: a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

TY - JOUR

T1 - Influenza H1N1 (swine flu) vaccination

T2 - a safety surveillance feasibility study using self-reporting of serious adverse events and pregnancy outcomes

AU - Mackenzie, Isla S

AU - Macdonald, Thomas M

AU - Shakir, Saad

AU - Dryburgh, Moira

AU - Mantay, Brian J

AU - McDonnell, Patrick

AU - Layton, Deborah

N1 - MEDLINE® is the source for the MeSH terms of this document.

PY - 2012

Y1 - 2012

N2 - 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 National Institute of Health Research, monitoring by specialist neurologists and the MHRA. • There were calls 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.

AB - 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 National Institute of Health Research, monitoring by specialist neurologists and the MHRA. • There were calls 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.

KW - H1N1 vaccination

KW - GUILLAIN-BARRE-SYNDROME

KW - safety surveillance

KW - IMMUNIZATION

KW - VIRUS

KW - post marketing

UR - https://www.scopus.com/pages/publications/84859376504

U2 - 10.1111/j.1365-2125.2011.04142.x

DO - 10.1111/j.1365-2125.2011.04142.x

M3 - Article

C2 - 22082196

SN - 1365-2125

VL - 73

SP - 801

EP - 811

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

IS - 5

ER -