Short and Long-Term Safety of the 2009 AS03-Adjuvanted Pandemic Vaccine

Gaston De Serres, Marie-Claude Gariépy, Brenda Coleman, Isabelle Rouleau, Shelly McNeil, Mélanie Benoît, Allison McGeer, Ardith Ambrose, Judy Needham, Chantal Bergeron, Cynthia Grenier, Kenna Sleigh, Arlene Kallos, Manale Ouakki, Najwa Ouhoummane, Grant Stiver, Louis Valiquette, Anne McCarthy, Julie Bettinger and on behalf of the PHAC-CIHR influenza Research Network (pcirn)

PLOS ONE, 2012, vol. 7, issue 7, 1-8

Abstract: Background: This study assessed the short and the long term safety of the 2009 AS03 adjuvanted monovalent pandemic vaccine through an active web-based electronic surveillance. We compared its safety profile to that of the seasonal trivalent inactivated influenza vaccine (TIV) for 2010–2011. Methodology/Principal Findings: Health care workers (HCW) vaccinated in 2009 with the pandemic vaccine (Arepanrix ® from GSK) or HCW vaccinated in 2010 with the 2010–2011 TIV were invited to participate in a web-based active surveillance of vaccine safety. They completed two surveys the day-8 survey covered the first 7 days post-vaccination and the day-29 survey covered events occurring 8 to 28 days after vaccination. Those who reported a problem were called by a nurse to obtain details. The main outcome was the occurrence of a new health problem or the worsening of an existing health condition that resulted in a medical consultation or work absenteeism. For the pandemic vaccine, a six-month follow-up for the occurrence of serious adverse events (SAE) was conducted. Among the 6242 HCW who received the pandemic vaccine, 440 (7%) reported 468 events compared to 328 of the 7645 HCW (4.3%) who reported 339 events after the seasonal vaccine. The 2009 pandemic vaccine was associated with significantly more local reactions than the 2010–2011 seasonal vaccine (1% vs. 0.03%, p

Date: 2012
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0038563

DOI: 10.1371/journal.pone.0038563

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