Researchers at Dundee University said yesterday that the rapid reporting of data, from thousands of people who received the 2009-10 swine flu vaccination in Scotland, could add another layer of safety to future vaccination campaigns.
The data, published in the British Journal of Clinical Pharmacology, showed “no significant safety issues” in patients exposed to the vaccine.
The majority of the 3,754 participants were e-mailed once a month, and a few contacted by text, letter and phone, for seven months and asked if they had experienced any serious medical problems which they believed were related to the vaccine.
While there are long-standing mechanisms for collecting data about side-effects once a vaccination or medicine starts to be used, the processes are often slow, and it can take months or years before the data is analysed and the results made known.
Professor Tom MacDonald, lecturer in clinical pharmacology at the university, who suggested the study, said the project had provided inexpensive high-quality data whose methodology would be of interest to bodies such as the World Health Organisation.
In 2009, the UK government recommended that some groups of people should be vaccinated against swine flu because the disease was spreading quickly worldwide. To meet the timescales, vaccines were moved more rapidly than usual through the test and production phases, leading to fears this could trigger unwanted reactions.
Led by Dr Isla Mackenzie from the medicines monitoring unit at the University of Dundee and Dr Deborah Layton from the independent academic drug safety research unit in Southampton, the team collected data from participants at the time they were vaccinated, and a further 312 people who were offered vaccination, but declined.
Dr Mackenzie said: “We asked people to let us know whether they had any serious health problems following being offered swine flu vaccination.
Dr Mackenzie added: “The use of web-based technology in the study was successful in reducing costs and allowing the collection of high-quality data directly from patients. This method for near ‘real-time’ monitoring, with minimal additional workload for healthcare staff, should be considered as an additional tool for other safety studies.”