Short and Long-Term Safety of the 2009 AS03- Adjuvanted Pandemic Vaccine De Serres, Gaston; Gariépy, Marie-Claude; Coleman, Brenda; Rouleau, Isabelle; McNeil, Shelly; Benoît, Mélanie; McGeer, Allison; Ambrose, Ardith; Needham, Judy; Bergeron, Chantal; Grenier, Cynthia; Sleigh, Kenna Marie; Kallos, Arlene; Ouakki, Manale; Ouhoummane, Najwa; Stiver, Grant; Valiquette, Louis; McCarthy, Anne; Bettinger, Julie A.; PHAC-CIHR influenza Research Network (PCIRN)
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 H 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,0.001). Paresthesia was reported by 7 HCW (0.1%) after the pandemic vaccine but by none after the seasonal vaccine. For the pandemic vaccine, no clustering of SAE was found in the 6 month follow-up. Conclusion: The 2009 pandemic vaccine seems to have a good safety profile, similar to the 2010–2011 TIV, with the exception of local reactions. This surveillance was adequately powered to identify AE associated with an excess risk $1 per 1000 vaccinations but is insufficient to detect rare AE.
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