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Safety and Immunogenicity of the BNT162b2 Vaccine Coadministered with Seasonal Inactivated Influenza Vaccine in Adults

journal contribution
posted on 2023-11-09, 04:35 authored by L Murdoch, K Quan, JA Baber, AWY Ho, Y Zhang, X Xu, C Lu, D Cooper, K Koury, SP Lockhart, AS Anderson, Ö Türeci, U Şahin, KA Swanson, WC Gruber, N Kitchin, M Arya, Eugene AthanEugene Athan, T Blackmore, S Bull, A Edwards, E Esquilant, J Finlay, P Hamilton, T Hemi, T Humphrey, J Kamerbeek, J Kerr, J Kok, A McGirr, B Montgomery, AM Neville, D Quinn, D Sheahan, S Smith, R Stubbs, M Tagelagi, C Thurlow, M Williams, J Wojciechowska
Introduction: Vaccination is a critical tool for preventing coronavirus disease 2019 (COVID-19) and influenza illnesses. Coadministration of the COVID-19 vaccine, BNT162b2, with seasonal inactivated influenza vaccine (SIIV) can provide substantial benefits, including streamlining vaccine delivery. Methods: In this phase 3 study, healthy 18- to 64-year-olds who had received three previous doses of BNT162b2 were randomized (1:1) to the coadministration group (month 0, BNT162b2 + SIIV; month 1, placebo) or the separate-administration group (month 0, placebo + SIIV; month 1, BNT162b2). The primary immunogenicity objective was to demonstrate that the immune responses elicited by BNT162b2 and SIIV [measured by full-length S-binding immunoglobulin G (IgG) levels and strain-specific hemagglutination inhibition assay (HAI) titers against four influenza strains 1 month post-vaccination, respectively] when coadministered were noninferior to those elicited by either vaccine administered alone, based on a prespecified 1.5-fold noninferiority margin [lower bound 95% CI for geometric mean ratio (GMR) > 0.67]. Reactogenicity and adverse event (AE) rates were evaluated. Results: Randomized participants who received study vaccination (N = 1128; coadministration group, n = 564; separate-administration group, n = 564) had a median age of 39 years. Model-adjusted GMRs for coadministration to separate administration were 0.83 (95% CI 0.77, 0.89) for full-length S-binding IgG levels and 0.89–1.00 (lower bound of all 95% CIs > 0.67) for the four influenza strain-specific HAI titers, with all endpoints achieving the prespecified noninferiority criterion. Reactogenicity events were mostly mild or moderate when BNT162b2 was coadministered with SIIV. Serious AEs were reported in < 1% of participants within 1 month after any vaccination; none were considered vaccine-related. Conclusions: BNT162b2 coadministered with SIIV elicited immune responses that were noninferior to those elicited by BNT162b2 alone and SIIV alone, and BNT162b2 had an acceptable safety profile when coadministered with SIIV. The results of this study support the coadministration of BNT162b2 and SIIV in adults. Trial Registration: ClinicalTrials.gov registration: NCT05310084.

History

Journal

Infectious Diseases and Therapy

Volume

12

Pagination

2241-2258

Location

New Zealand

ISSN

2193-8229

eISSN

2193-6382

Language

en

Publication classification

C1.1 Refereed article in a scholarly journal

Issue

9

Publisher

Springer Science and Business Media LLC