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Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012 Bettinger, Julie A.; Rouleau, Isabelle; Gariépy, Marie-Claude; Bowie, William R.; Valiquette, Louis; Vanderkooi, Otto G.; Kellner, James D.; Coleman, Brenda; McNeil, Shelly; McCarthy, Anne; De Serres, Gaston
Abstract
In 2011 and 2012, a nationwide Canadian vaccine safety surveillance network rapidly collected safety data from healthcare workers (HCW) during the first weeks of the annual influenza vaccination campaign. This network provided the first available post-marketing safety data on seasonal influenza vaccines with information on background rates as a comparator. In 2012, these data were used to investigate a possible safety concern regarding a particular vaccine. An online questionnaire was provided to participating HCW two weeks before the annual influenza vaccination campaign for controls, and eight days after influenza vaccination for vaccinees. Control and vaccinees were requested to report health events occurring in the seven days prior to receiving the questionnaire. Control data were used to calculate background rates. HCW reporting a severe event were followed-up by telephone within 48 hours of the online report to validate the report and check on their health status. More than 22,000 vaccinated HCW were enrolled and surveyed over two seasons and > 90% reported no severe event following vaccination. Validated severe event rates were similar in vaccinated HCW and unvaccinated HCW (2.2% vs 2.3%; p < 0.70). The questionnaire was accurately completed for most reported symptoms, matched the validated report and was able to detect events of interest. Prior to the safety concern, the implicated vaccine was in use at one centre. Reassuring safety data were provided to public health authorities 48 hours after the vaccine was temporarily suspended. Data from this and similar networks can be used for rapid evaluation of vaccine safety and for safety assessment as required by the European Medicines Agency in 2015.
Item Metadata
Title |
Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012
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Creator | |
Date Issued |
2015
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Description |
In 2011 and 2012, a nationwide Canadian vaccine safety
surveillance network rapidly collected safety data from
healthcare workers (HCW) during the first weeks of the
annual influenza vaccination campaign. This network
provided the first available post-marketing safety data
on seasonal influenza vaccines with information on
background rates as a comparator. In 2012, these data
were used to investigate a possible safety concern
regarding a particular vaccine. An online questionnaire
was provided to participating HCW two weeks
before the annual influenza vaccination campaign for
controls, and eight days after influenza vaccination for
vaccinees. Control and vaccinees were requested to
report health events occurring in the seven days prior
to receiving the questionnaire. Control data were used
to calculate background rates. HCW reporting a severe
event were followed-up by telephone within 48 hours
of the online report to validate the report and check
on their health status. More than 22,000 vaccinated
HCW were enrolled and surveyed over two seasons
and > 90% reported no severe event following vaccination.
Validated severe event rates were similar in vaccinated
HCW and unvaccinated HCW (2.2% vs 2.3%;
p < 0.70). The questionnaire was accurately completed
for most reported symptoms, matched the validated
report and was able to detect events of interest. Prior
to the safety concern, the implicated vaccine was in use
at one centre. Reassuring safety data were provided to
public health authorities 48 hours after the vaccine
was temporarily suspended. Data from this and similar
networks can be used for rapid evaluation of vaccine
safety and for safety assessment as required by the
European Medicines Agency in 2015.
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Genre | |
Type | |
Language |
eng
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Date Available |
2016-03-08
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution 2.5 Canada
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DOI |
10.14288/1.0228080
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URI | |
Affiliation | |
Citation |
Bettinger, J. A., Rouleau, I., Gariepy, M. C., Bowie, W. R., Valiquette, L., Vanderkooi, O. G., . . . De Serres, G. (2015). Successful methodology for large-scale surveillance of severe events following influenza vaccination in Canada, 2011 and 2012. Euro Surveillance: Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin, 20(29), 21189.
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Peer Review Status |
Reviewed
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Scholarly Level |
Faculty
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Rights URI | |
Aggregated Source Repository |
DSpace
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Item Citations and Data
Rights
Attribution 2.5 Canada