DSRU Leaders in risk management studies Leaders in risk management studies Passive Enhanced Safety...
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DSRU Leaders in risk management studies Passive Enhanced Safety Surveillance in Children Receiving Fluenz® Tetra Vaccination in England during the Early 2015-16 Influenza Season L. Hazell¹, S. Shakir¹, A. Finlay², H. Coulter², R.S. Brody³, R.P. Wise³ ¹DSRU Education & Research Ltd., Southampton, UK, ²AstraZeneca, Luton, UK, ³AstraZeneca, Gaithersburg, USA To assess the frequencies of suspected adverse drug reactions (sADRs) in children receiving Fluenz® Tetra during the early 2015-16 flu season in England. • Passive enhanced safety surveillance (ESS) was conducted through stimulated spontaneous reporting of sADRs (Figure 1). • This programme was supported by the UK Clinical Research Network and received Ethics Committee approvals. Figure 1 – Overview of passive ESS programme GP practices and school nurse teams agree to take part Children aged 2-17 years vaccinated as part of national immunisation programme Vaccinees given Safety Report Card (SRC) post-vaccination Vaccinees return SRC if sADR experienced sADR data assessed and entered on safety database Analysis of data and report to regulator Site staff record no. of vaccinees given an SRC by age group and lot Counts shared on weekly basis with surveillance team • Data collection period: 8 th October 2015 to 10 th January 2016. • Participating sites: • 42 general practices and 25 primary schools in England. • SRCs issued: • 8,753 in total. • 4,134 (47.2%) aged 2 to 4 years. • 4,078 (46.6%) aged 5 to 10 years. • 541 (6.2%) aged 11 to 17 years. • SRCs returned: • 321 in total; 165 SRCs reported at least one sADR. • Represents 1.9% of all SRCs issued during the surveillance. • Characteristics of vaccinees experiencing sADR (Figure 2): • Majority were children aged 2-4 years (87, 52.7%). • 90 (54.5%) for boys, 74 (44.8%) for girls; one SRC did not specify gender. Background Objective • Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza (flu) vaccine. 1 • It is recommended for use in children 2-17 years of age in the seasonal influenza immunisation programme in England. 2 • We conducted an early season pilot surveillance programme consistent with regulatory guidance for all influenza vaccines. Methods Results Figure 2 – Age/gender distribution • sADRs reported on SRCs: • Most frequently reported sADRs were respiratory symptoms (91 of 165 SRCs, 55.2%). • No sADR was reported at a frequency over 1%. • Table 1 shows 10 most frequently reported sADRs. • One (0.01%) serious and unexpected sADR (flu-like symptoms requiring a hospital visit 2 days after vaccination; child recovered from the sADR within 3 days). Table 1 – Top 10 most frequently reported sADRs Suspected ADR No. of reports % of SRCs issued (N=8,753) Rhinorrhoea 54 0.62 Cough 35 0.40 Pyrexia 31 0.35 Fatigue 29 0.33 Headache 23 0.26 Nasopharyngitis 19 0.22 Decreased appetite 17 0.19 Oropharyngeal pain 16 0.18 Body temperature increased 14 0.16 Nasal congestion 13 0.15 Results No. of SRCs returned by age and gender (N=164; one SRC did not specify gender) 50 38 25 13 0 2-4 years 5-10 years 11-17 years NS Boys Girls • Pattern of sADRs reported in this pilot safety surveillance programme was broadly comparable with the frequency of adverse events reported for Fluenz® Tetra in clinical trial and post-marketing data, despite differences in methods. • Limitations include the relatively small numbers and limited power to detect rare (>1/10,000 and <1/1,000) and very rare events (<1/10,000). • No evidence from the data to suggest an increased frequency of minor expected events or other safety signals in the 2015-16 season. Conclusion REFERENCES: [1] MedImmune UK Ltd. Summary of Product Characteristics - Fluenz®Tetra. [2] Joint Committee for Vaccination and Immunisation. Statement on the annual influenza vaccination programme - extension of the programme to children. Department of Health 2012. DSRU Education and Research Ltd www.dsru.org DISCLOSURES: Project co-sponsored by DSRU Education & Research Ltd. and AstraZeneca. Copyright © 2016 email: [email protected]
Transcript of DSRU Leaders in risk management studies Leaders in risk management studies Passive Enhanced Safety...
DSRU Leaders in risk management studies
Passive Enhanced Safety Surveillance in Children Receiving Fluenz® Tetra Vaccination in England during the Early 2015-16 Influenza Season
L. Hazell¹, S. Shakir¹, A. Finlay², H. Coulter², R.S. Brody³, R.P. Wise³¹DSRU Education & Research Ltd., Southampton, UK, ²AstraZeneca, Luton, UK, ³AstraZeneca, Gaithersburg, USA
To assess the frequencies of suspected adverse drug reactions (sADRs) in children receiving Fluenz® Tetra during the early 2015-16 flu season in England.
• Passive enhanced safety surveillance (ESS) was conducted through stimulated spontaneous reporting of sADRs (Figure 1).
• This programme was supported by the UK Clinical Research Network and received Ethics Committee approvals.
Figure 1 – Overview of passive ESS programme
GP practices and school nurse teams agree to take part
Children aged 2-17 years vaccinated as part of national immunisation programme
Vaccinees given Safety Report
Card (SRC) post-vaccination
Vaccinees return SRC if sADR experienced
sADR data assessed and entered on safety
database
Analysis of data and report to regulator
Site staff record no. of vaccinees given an SRC by age group and lot
Counts shared on weekly basis with
surveillance team
• Data collection period: 8th October 2015 to 10th January 2016. • Participating sites: • 42 general practices and 25 primary schools in England.
• SRCs issued: • 8,753 in total. • 4,134 (47.2%) aged 2 to 4 years. • 4,078 (46.6%) aged 5 to 10 years. • 541 (6.2%) aged 11 to 17 years. • SRCs returned: • 321 in total; 165 SRCs reported at least one sADR. • Represents 1.9% of all SRCs issued during the surveillance.
• Characteristics of vaccinees experiencing sADR (Figure 2): • Majority were children aged 2-4 years (87, 52.7%). • 90 (54.5%) for boys, 74 (44.8%) for girls; one SRC did not specify gender.
Background
Objective
• Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza (flu) vaccine.1
• It is recommended for use in children 2-17 years of age in the seasonal influenza immunisation programme in England.2
• We conducted an early season pilot surveillance programme consistent with regulatory guidance for all influenza vaccines.
Methods
Results
Figure 2 – Age/gender distribution
• sADRs reported on SRCs:• Most frequently reported sADRs were respiratory symptoms (91
of 165 SRCs, 55.2%).• No sADR was reported at a frequency over 1%.• Table 1 shows 10 most frequently reported sADRs.• One (0.01%) serious and unexpected sADR (flu-like symptoms
requiring a hospital visit 2 days after vaccination; child recovered from the sADR within 3 days).
Table 1 – Top 10 most frequently reported sADRs
Suspected ADR No. of reports % of SRCs issued (N=8,753)
Rhinorrhoea 54 0.62
Cough 35 0.40
Pyrexia 31 0.35
Fatigue 29 0.33
Headache 23 0.26
Nasopharyngitis 19 0.22
Decreased appetite 17 0.19
Oropharyngeal pain 16 0.18
Body temperature increased 14 0.16
Nasal congestion 13 0.15
Results
No. of SRCs returned by age and gender (N=164; one SRC did not specify gender)50
38
25
13
02-4 years 5-10 years 11-17 years NS
BoysGirls
• Pattern of sADRs reported in this pilot safety surveillance programme was broadly comparable with the frequency of adverse events reported for Fluenz® Tetra in clinical trial and post-marketing data, despite differences in methods.
• Limitations include the relatively small numbers and limited power to detect rare (>1/10,000 and <1/1,000) and very rare events (<1/10,000).
• No evidence from the data to suggest an increased frequency of minor expected events or other safety signals in the 2015-16 season.
Conclusion
REFERENCES: [1] MedImmune UK Ltd. Summary of Product Characteristics - Fluenz®Tetra. [2] Joint Committee for Vaccination and Immunisation. Statement on the annual influenza vaccination programme - extension of the programme to children. Department of Health 2012.
DSRU Education and Research Ltd www.dsru.org
DISCLOSURES: Project co-sponsored by DSRU Education & Research Ltd. and AstraZeneca. Copyright © 2016 email: [email protected]
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