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Rapid Safety Monitoring of H1N1 Vaccine Feasible

Uses modern technology to collect rapid self-reported safety data in large numbers of patients

FRIDAY, Nov. 18 (HealthDay News) -- A rapid safety surveillance system using modern technology is feasible for monitoring new H1N1 vaccines given or offered to large numbers of patients under normal conditions within a short period of time, according to a study published online Nov. 15 in the British Journal of Clinical Pharmacology.

Isla S. Mackenzie, M.D., Ph.D., from the University of Dundee in the United Kingdom, and colleagues determined the feasibility of a rapid, large-scale surveillance system that uses modern technology for safety monitoring of new H1N1 vaccines. Safety data were collected from participants who either received (3,754 individuals) or were offered (312 individuals) the vaccination during the 2009 to 2010 winter H1N1 vaccination program in the United Kingdom. Self-reported serious adverse events (SAEs) and pregnancy outcomes were the main outcomes measured.

The investigators found that 53 of the 939 self-reported events fit the SAE criteria; and nine of these events were judged as possibly, probably, or definitely related to the vaccine. Seven deaths were observed, of which six were in the vaccinated group. None of the deaths were determined to be related to the vaccine. Pregnancy was noted in 117 participants at the start of the study. In total, 130 pregnancies were reported in 128 women during the follow-up, with six possible congenital abnormalities in live births. Three women reported a total of four miscarriages.

"Overall, 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," the authors write.

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