Evidence map›Paper›PMID 37698774›Full record

ArticleInfectious diseases and therapy2023

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

Louise Murdoch, Karen Quan, James A Baber, Agnes W Y Ho, Ying Zhang, Xia Xu, Claire Lu, David Cooper, Kenneth Koury, Stephen P Lockhart and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05310084 (A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05310084 phase3completednot on this map

A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE

TypeinterventionalSponsorBioNTech SERan2022 to 2022Enrolled1,134ConditionsSARS-CoV-2 Infection, COVID-19ArmsBNT162b2, Placebo, Seasonal Inactivated Influenza Vaccine
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
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  15. Article
  16. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 4 countries.

Louise MurdochEmeritus Research, Camberwell, VIC, Australia.
Karen QuanVaccine Clinical Research and Development, Pfizer Australia Pty Ltd, Sydney, NSW, Australia. Karen.Quan@pfizer.com.
James A BaberVaccine Clinical Research and Development, Pfizer Australia Pty Ltd, Sydney, NSW, Australia.
Agnes W Y HoVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Ying ZhangVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Xia XuVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Claire LuVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
David CooperVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Kenneth KouryVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Stephen P LockhartVaccine Research and Development, Pfizer Ltd, Hurley, UK.
Annaliesa S AndersonVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Özlem TüreciBioNTech, Mainz, Germany.
Uğur ŞahinBioNTech, Mainz, Germany.
Kena A SwansonVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
William C GruberVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Nicholas KitchinVaccine Research and Development, Pfizer Ltd, Hurley, UK.
C4591030 Clinical Trial Group
Pfizer (United States) · USBioNTech (Germany) · DEPfizer (Australia) · AUPfizer (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionVaccination 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.

methodsIn 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.

resultsRandomized 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.

conclusionsBNT162b2 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 registrationClinicalTrials.gov registration: NCT05310084.

Indexed as

BNT162b2Clinical trialCoadministrationCOVID-19ImmunogenicityInfluenzaSafetySeasonal inactivated influenza vaccineVaccination

Identifiers

PMID37698774
PMCPMC10581992
OpenAlexW4386624325

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.