Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16

Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin
Hélène BricoutTimothy David Caroe

Abstract

Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 µg vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorit...Continue Reading

References

Jan 30, 2004·British Journal of Clinical Pharmacology·P A RoutledgeK W Woodhouse
Dec 17, 2009·Vaccine·Ian G BarrUNKNOWN Writing Committee of the World Health Organization Consultation on Northern Hemisphere Influenza Vaccine Composition for 200
Feb 4, 2011·The New England Journal of Medicine·Xiao-Feng LiangYu Wang
Dec 6, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Hazel J ClothierJim P Buttery

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Citations

Jan 4, 2018·Human Vaccines & Immunotherapeutics·Claudia Maria TrombettaEmanuele Montomoli
Mar 3, 2020·Human Vaccines & Immunotherapeutics·Simon de LusignanGael Dos Santos
Mar 11, 2020·Micromachines·Liping XieWei Qian

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