Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine.
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.


RESULTS
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<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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT01289418, NCT01318876.
Centre de recherche du CHUQ-CHUL, Laval University, Quebec City, Quebec, Canada. gaston.deserres@ssss.gouv.qc.ca
Gaston
G
De Serres
Marie-Claude
MC
Gariépy
Brenda
B
Coleman
Isabelle
I
Rouleau
Shelly
S
McNeil
Mélanie
M
Benoît
Allison
A
McGeer
Ardith
A
Ambrose
Judy
J
Needham
Chantal
C
Bergeron
Cynthia
C
Grenier
Kenna
K
Sleigh
Arlene
A
Kallos
Manale
M
Ouakki
Najwa
N
Ouhoummane
Grant
G
Stiver
Louis
L
Valiquette
Anne
A
McCarthy
Julie
J
Bettinger
D000276:Adjuvants, Immunologic; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006282:Health Personnel; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D058873:Pandemics; D010292:Paresthesia / Q000139:chemically induced
D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C568072:arepanrix