tetano
Editor, Senior Moderator
BMJ Open. 2018 Oct 18;8(10):e023263. doi: 10.1136/bmjopen-2018-023263.
[h=1]Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.[/h] Pillsbury AJ[SUP]1[/SUP], Glover C[SUP]1[/SUP], Jacoby P[SUP]2[/SUP], Quinn HE[SUP]1,[/SUP][SUP]3[/SUP], Fathima P[SUP]2[/SUP], Cashman P[SUP]4[/SUP], Leeb A[SUP]5,[/SUP][SUP]6[/SUP], Blyth CC[SUP]2,[/SUP][SUP]7,[/SUP][SUP]8,[/SUP][SUP]9[/SUP], Gold MS[SUP]10[/SUP], Snelling T[SUP]2,[/SUP][SUP]8,[/SUP][SUP]11,[/SUP][SUP]12[/SUP], Macartney KK[SUP]1,[/SUP][SUP]3,[/SUP][SUP]13[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety.
[h=4]DESIGN AND SETTING:[/h] Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia.
[h=4]PARTICIPANTS:[/h] Individuals aged ≥6 months who received a routine seasonal influenza vaccine at a participating site (n=102 911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73 892; 71.8%).
[h=4]MAIN OUTCOME MEASURE:[/h] Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt.
[h=4]RESULTS:[/h] Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42 869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ≥65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels.
[h=4]CONCLUSIONS:[/h] Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.
? Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
[h=4]KEYWORDS:[/h] active surveillance; epidemiology; vaccine safety
PMID: 30341132 DOI: 10.1136/bmjopen-2018-023263
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[h=1]Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia.[/h] Pillsbury AJ[SUP]1[/SUP], Glover C[SUP]1[/SUP], Jacoby P[SUP]2[/SUP], Quinn HE[SUP]1,[/SUP][SUP]3[/SUP], Fathima P[SUP]2[/SUP], Cashman P[SUP]4[/SUP], Leeb A[SUP]5,[/SUP][SUP]6[/SUP], Blyth CC[SUP]2,[/SUP][SUP]7,[/SUP][SUP]8,[/SUP][SUP]9[/SUP], Gold MS[SUP]10[/SUP], Snelling T[SUP]2,[/SUP][SUP]8,[/SUP][SUP]11,[/SUP][SUP]12[/SUP], Macartney KK[SUP]1,[/SUP][SUP]3,[/SUP][SUP]13[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]OBJECTIVE:[/h] To actively solicit adverse events experienced in the days following immunisation with quadrivalent inactivated influenza vaccine using Australia's near real-time, participant-based vaccine safety surveillance system, AusVaxSafety.
[h=4]DESIGN AND SETTING:[/h] Observational cohort study conducted in 194 sentinel surveillance immunisation sites (primary care, hospital and community-based clinics) across Australia.
[h=4]PARTICIPANTS:[/h] Individuals aged ≥6 months who received a routine seasonal influenza vaccine at a participating site (n=102 911) and responded to a survey (via short message service or email) sent 3 days after vaccination about adverse events experienced (n=73 892; 71.8%).
[h=4]MAIN OUTCOME MEASURE:[/h] Near real-time and cumulative participant-reported rates of any adverse event, fever or medical attendance experienced within 3 days after vaccination overall, by brand, age, pregnancy status and concomitant vaccine receipt.
[h=4]RESULTS:[/h] Participant median age was 57 years (range: 6 months to 102 years); 58.1% (n=42 869) were female and 2.7% (n=2018) were pregnant. Near real-time fast initial response cumulative summation and Bayesian analyses of weekly event rates did not demonstrate a safety signal. Children aged 6 months to 4 years had higher event rates (522/6180; 8.4%) compared with older ages; participants aged ≥65 years reported fewer events (1695/28 154; 6.0%). There were no clinically significant differences in safety between brands, by age group or overall. Cumulative data analysis demonstrated that concomitant vaccination was associated with increased rates of fever (2.1% vs 0.8%) and medical attendance (0.8% vs 0.4%), although all rates were low and did not exceed expected levels.
[h=4]CONCLUSIONS:[/h] Novel, postmarketing AusVaxSafety surveillance demonstrated comparable and expected safety outcomes for the 2017 quadrivalent inactivated influenza vaccine brands used in Australia. These near real-time, participant-reported data are expected to encourage confidence in vaccine safety and promote uptake.
? Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
[h=4]KEYWORDS:[/h] active surveillance; epidemiology; vaccine safety
PMID: 30341132 DOI: 10.1136/bmjopen-2018-023263
Free full text