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Technologies facilitated safety surveillance of 2009 flu vaccine in UK
Mackenzie IS. Br J Clin Pharmacol. 2011;doi:10.1111/j.1365-2125.2011.04142.x. In press.
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Researchers from the United Kingdom reported that the use of modern technologies to collect safety data on influenza vaccinations during the 2009 pandemic was feasible and yielded no significant safety issues.
According to background information in the study, despite the rigorous safety and efficacy testing conducted for H1N1 vaccinations, concerns remained about unexpected adverse effects.
For this reason, Isla S. Mackenzie, MBChB, PhD, FRCP,of the University of Dundee, and colleagues conducted a pilot study to assess the feasibility of a prospective active surveillance system for near real-time vaccine safety monitoring. Internet-based technologies were used to monitor 3,754 vaccinated participants and 312 participants who did not receive the vaccine.
“We asked people to let us know whether they had any serious health problems after being offered swine flu vaccination,” Mackenzie said in a press release. “We also followed a group of pregnant women who were offered [the vaccine] to check whether there were any problems with their pregnancies or their [newborns].”
Participants provided monthly follow-up reports on their health status, via email or text message, for up to 6 months. Of 939 self-reported events, 53 were considered serious adverse events, and nine were “possibly,” “probably” or “definitely” vaccine-related. There were 130 pregnancies reported during the surveillance period, of which four miscarriages and six possible congenital abnormalities in live births were reported.
“This adds further evidence for the safety of the 2009-2010 H1N1 swine flu vaccine,” Mackenzie told Infectious Disease News. “The use of Internet technology in the study enabled collection of large amounts of patient self-reported data quickly and economically, and encouraged patient participation in the study, which addressed an important public health question.” – by Ashley DeNyse
Disclosure: Dr. Mackenzie reports no relevant financial disclosures.
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