Abstract
AIMSDuring 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.METHODSA cohort design with safety data capture through modern technologies was carried out in Scotland, UK during the winter swine flu vaccination programme 2009–2010 in individuals receiving or offered the swine flu vaccination. The main outcome measures were self-reported serious adverse events (SAEs) and pregnancy outcomes.RESULTSThe cohort comprised 4066 people; 3754 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 nine judged as possibly, probably or definitely vaccine related. None of the seven deaths (six in vaccinees) were judged as vaccine related. One hundred and twenty-eight women reported 130 pregnancies during the study with 117 pregnant at study start. There were reports of four miscarriages in three women and six possible congenital abnormalities in live births.CONCLUSIONSOverall, 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.
Highlights
In April 2009, the first cases of human influenza A (H1N1) (‘swine flu’) were identified in Mexico, Canada and the US [1].The virus spread rapidly to other parts of the world and a global flu pandemic was declared in June 2009 by the World Health Organization (WHO).The rapid development of H1N1 vaccines to prevent further morbidity and mortality became a public health priority and the first vaccines were licensed in October 2009
A mass vaccination programme for high risk groups was introduced in the UK from late October 2009 onwards
The results of this study indicate that a large-scale prospective active surveillance system for ‘near real-time’ vaccine safety monitoring that would be complementary to other initiatives is feasible
Summary
In April 2009, the first cases of human influenza A (H1N1) (‘swine flu’) were identified in Mexico, Canada and the US [1].The virus spread rapidly to other parts of the world and a global flu pandemic was declared in June 2009 by the World Health Organization (WHO).The rapid development of H1N1 vaccines to prevent further morbidity and mortality became a public health priority and the first vaccines were licensed in October 2009. A mass vaccination programme for high risk groups was introduced in the UK from late October 2009 onwards. In Scotland, the vaccination programme was launched on 21 October 2009. In a second phase of the programme, young children aged over 6 months and up to 5 years of age were prioritized for vaccination between December 2009 and March 2010 [2]. Around 500 000 people in Scotland were vaccinated against H1N1 influenza between November 2009 and April 2010 (>5 million in the UK) [3]
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