23 November 2009
New study of swine flu vaccination in Scotland
A new study to identify any rare side effects of the swine flu vaccination is being launched in Scotland this week by the University of Dundee.
Safety studies have already been carried out on the vaccine as part of the licensing process, and these have shown the vaccine to be safe. However, follow-up of large numbers of people can identify any very rare side effects of the vaccine that cannot normally be identified through routine clinical trials. This kind of ongoing monitoring takes place routinely for all new vaccines.
The study is being run by the Medicines Monitoring Unit (MEMO), University of Dundee, in collaboration with the Drug Safety Research Unit (DSRU), Southampton.
The study is being rolled out in stages across Scotland. People who have been offered swine flu
vaccination can take part in the study by registering for the study online at www.safetyswineflu.co.uk); by picking up a form from their GP surgery; or by phoning 0800 9173509.
The study will use internet and mobile phone technology to streamline the data collection and processing. The study organisers hope as many people as possible from all over Scotland will join the study. They will then be followed up for a year after their swine flu vaccination to monitor for any rare side effects.
The study will also look for people who were offered swine flu vaccination but decided not to accept it. This will allow comparison to be drawn between the sections of the population who took the vaccine and those who didn’t.
Initially, the study will only look at people aged 16 and over, but it is hoped to expand the study in the near future to include children.
Dr Isla Mackenzie, consultant physician with MEMO and lead doctor on the study, said, 'Working with very large numbers of people is the only way to pick up extremely rare but important side effects of drugs or vaccines, such as those that only occur in 1 in 10,000 people. While the swine flu vaccine has been licensed and passed as safe to administer to the population, it is routine for new vaccines to continue to be monitored. It is good news for Scotland that we are able to mount such a study here and we hope that the public will help us by taking part in this important study.'
'The vaccination programme is now underway and by using online technology we think we can quickly get a lot of people involved in this study. It is a novel project in that sense, but the technology is there and people are comfortable with it, so we think it could be a very good way of recruiting people into a large study.'
Dr Deborah Layton, pharmacist and principal research fellow from the Drug Safety Research Unit,
added, 'This study is complementary to other studies being conducted to monitor the swine flu vaccine, and offers the potential for near ‘real-time’ vaccine monitoring and alerts, with minimal additional workload for doctors and nurses involved in the vaccination programme.'
The Medicines Monitoring Unit has been able to set up the study relatively quickly to get it running while the vaccination programme is still in its early stages. Funding for the study has come internally from the University.
'As a University unit we have the resources to get this academic study off the ground as a side-benefit from the commercial research we do on other projects,' said Professor Tom MacDonald, of MEMO.
More information is available at www.safetyswineflu.co.uk/).
NOTES TO EDITORS
The UK government and the devolved administrations including Scotland have initiated a programme of vaccination in response to an outbreak of H1N1 influenza A viral infection (swine flu). Licenses have been granted via an expedited approval process to vaccine manufacturers for the newly developed swine flu vaccinations. As this programme gets underway, monitoring in extremely large numbers of people who have received the vaccination will enable the identification of any very rare side effects from the vaccination.
A number of studies are being conducted in the UK to monitor the vaccine and the epidemiology
of swine flu. This proposal is complementary to these initiatives. It is a pilot study for a
large-scale active surveillance system to monitor the vaccination in the UK population using novel
data collection methods. The study is being conducted by the University of Dundee (www.dundee.ac.uk/),
in partnership with the Drug Safety Research Unit (www.dsru.org/). The study aims to collect data from as many people as possible who were offered the swine flu vaccine. They will each be followed up over a one-year period. This number is needed to allow adequate appraisal of rare adverse events which may only occur in 1/10,000 people. Workload for GPs and nurses involved in the administration of the vaccine will be minimal.
The study will be conducted as follows:The study will be publicised (using posters and leaflets)
within GP surgeries to patients visiting their GPs. Patients who wish to participate
(whether vaccinated or not) will provide their consent and some very basic information on
their demography, current health status, date of vaccination (if vaccinated) and contact details
of next of kin.
Information technologies (Internet and mobile phones) will be used to collect data from patients
or their next of kin on simple outcomes (an event causing admission to hospital, receipt of
emergency treatment, pregnancy) to examine the feasibility of near real-time vaccine monitoring.
Other important additions such as linking to mortality data will be examined.
The Medicines Monitoring Unit (MEMO), University of Dundee is an academic centre studying drug
use and side effects.
The Drug Safety Research Unit in Southamptonis a registered independent medical research
charity that works in association with the University of Portsmouth. The Unit was established to
provide a monitoring system to safeguard public health following the introduction of new
medicines.
For media enquiries contact:
Grant Hill
Press Officer
University of Dundee
Nethergate, Dundee, DD1 4HN
TEL: 01382 384768
E-MAIL: g.hill@dundee.ac.uk
MOBILE: 07854 953277 |
