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Hum Vaccin Immunother. 2017 Nov 17:0. doi: 10.1080/21645515.2017.1405882. [Epub ahead of print]
Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season.
Chabanon AL1, Bricout H1, Ballandras C2, Souverain A3, Caroe TD4, Butler KM5.
Author information
Abstract
Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15?g influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15?g. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15?g (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15?g only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.
KEYWORDS:
Inactivated influenza vaccine; The Republic of Ireland; United Kingdom; influenza; passive surveillance; vaccines and immunization
PMID: 29148911 DOI: 10.1080/21645515.2017.1405882
Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season.
Chabanon AL1, Bricout H1, Ballandras C2, Souverain A3, Caroe TD4, Butler KM5.
Author information
Abstract
Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15?g influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15?g. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15?g (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15?g only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.
KEYWORDS:
Inactivated influenza vaccine; The Republic of Ireland; United Kingdom; influenza; passive surveillance; vaccines and immunization
PMID: 29148911 DOI: 10.1080/21645515.2017.1405882