04 bandell influenza 508

CDC ACIP — Vaccine Advisory Committee

Acip

Slides

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CO-9Instructions for Use Based on Human Factors Usability Studies 
that Aligned with FDA Guidance1
1. Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, Guidance for Industry and FDA Staff, 2023ObjectiveConfirm intended users can administer FluMist to themselves or to an 
appropriate child without errors or difficulties that could result in 
administration failure Confirm intended users can administer FluMist to themselves or to an 
appropriate child without errors or difficulties that could result in 
administration failure 
Intended 
UsersAdult patients aged 18 to 49 years (self-administered) 
Adult caregivers (≥18 years) who administer to adults or children 
(2-17 years)Adult patients aged 18 to 49 years (self-administered) 
Adult caregivers (≥18 years) who administer to adults or children 
(2-17 years)
Study 
RecruitmentIntended to reflect mix of male/female participants, race, 
educational background, right/left handedness, with or without nasal 
spray experienceIntended to reflect mix of male/female participants, race, 
educational background, right/left handedness, with or without nasal 
spray experience
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CO-18
Patients Answer Yes/No Questions Aligned with Flu ACIP 
Recommendations Allowing Pharmacists to Determine Eligibility 
women.17
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CO-19
Patients Answer Yes/No Questions Aligned with Flu ACIP 
Recommendations Allowing Pharmacists to Determine Eligibility 
women.women.
CO-20Patients Answer Yes/No Questions Aligned with Flu ACIP 
Recommendations Allowing Pharmacists to Determine Eligibility 
women.19
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CO-34
Global Vaccine Effectiveness of IIV and LAIV4 in Pediatric Patients –
Compilation from Non-Comparative Studies (2019-2024)
020406080100
65
(41, 79)59
(48, 67)67
(48, 80)VE, % (95% CI) 
DATA ARE UNAVAILABLE FOR 20/212019/20 2021/22 2022/23 2023/24
2 years 2–6 years45
(13, 66)
49
(25, 66)48
(8, 70)66
(58, 72)
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(37, 64)34
(19, 46)40
(22, 53)64
(51, 74)
13
(–70, 55)
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(36, 63)72
(50, 85)
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(19, 70)34
(–7, 59)64
(49, 75)77
(62, 86)
71
(31, 90)
72
(24, 89)
2–17 years 2–6 years
6 mo–17 years60
(57, 64)
UK1
n=N/A
2–17
yearsFIN2
n=195FIN2
n=178FIN2
n=1149FIN2
n=1102US3,4†
n=646
6 mo–
8 yearsUS3,4†
n=471
9–17
yearsDEN5‡
n=473FIN6§
n=349UK7
n=N/A
1–17
yearsUS8,9†ۅ
n=117
9–17 yearsFIN6§
n=299US8,9†ۅ
n=95
6 mo–
8 yearsUK10
n=N/ADEN11‡
n=339
2–6 yearsUS12†‡
n=34
1–17
yearsUK10
n=N/AUK13
RCGP, 
CARI
n=N/A
2–17
yearsUS14,15†
NVSN
n=622US14,15†
US Flu VE
n=283US14,15†
VISION
n=6068LAIV IIV
Data for FLUMIST Quadrivalent (LAIV4) are relevant to FLUMIST because both vaccines are 
manufactured using the same process and have overlapping compositions17
VE CIs truncated at 0 to enable graphical display. †Data for all vaccines, but little use of LAIV4 or IIV3 in the US.4,9,15,16 ‡Data for interim influenza A only. §End-of-season estimates from Week 40 (2021) to Week 26 (2022). ‖A(H3N2) represented an estimated 94% of all influenza-positive participants.
CI = confidence interval; DEN = Denmark; FIN = Finland;GB-PC = Great Britain Primary Care; IIV = inactivated influenza vaccine; IIV3 = trivalent inactivated influenza vaccine; LAIV = live attenuated influenza vaccine; LAIV4 = quadrivalent live attenuated influenza vaccine; 
mo = months; n = total number of cases; N/A = not available; NVSN = New Vaccine Surveillance Network; UK = United Kingdom; US = United States; VE = vaccine effectiveness; VISION = Virtual SARS-CoV-2, Influenza, and Other respiratory viruses Network.
1. Public Health England. Surveillance of influenza and other respiratory viruses in the UK. Winter 2019 to 2020; 2. In-house data, AstraZeneca. DoF 143691; 3. TenfordeMW et al. Article and supplementary appendix. Clin Infect Dis . 2021;73(11):e4244–e4250; 4. Committee on Infectious Diseases. Pediatrics . 
2019;144(4):e20192478; 5. EmborgH et al. Euro Surveill . 2022;27(15):2200278;6. In-house data, AstraZeneca. DoF 168928; 7. UK Health Security Agency. Surveillance of influenza and other seasonal respiratory viruses in winter 2021 to 2022; 8. Price AM et al. Clin Infect Dis. 2023;76(8):1358–1363; 9. Grohskopf LA et 
al. MMWR RecommRep. 2021;70(5):1–28; 10. UK Health Security Agency. Surveillance of influenza and other seasonal respiratory viruses in the UK, winter 2022 to 2023; 11. Kissling E et al. Euro Surveill. 2023;28(21):2300116; 12. McLean HQ et al. MMWR RecommRep. 2023;72(8):201–205; 13. UK Health Security 
Agency. Surveillance of influenza and other seasonal respiratory viruses in the UK, winter 2023 to 2024; 14. Frutos AM et al. MMWR MorbMortal WklyRep . 2024;73(8):168–174; 15. Grohskopf LA, et al. MMWR RecommRep . 2023;72(2):1–25; 16. Centersfor Disease Control and Prevention. Live Attenuated Influenza 
Vaccine [LAIV] (The Nasal Spray Flu Vaccine); 17. FLUMIST Prescribing Information. August 2024.33
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