Evidence map›Paper›PMID 40591130›Full record

ArticleInfectious diseases and therapy2025

Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial.

Oyeniyi Diya, Juleen Gayed, Francine S Lowry, Hua Ma, Vishva Bangad, Federico Mensa, Jing Zou, Xuping Xie, Yanping Hu, Mark Cutler and 11 more

Registry-linked trialAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05997290 (A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT05997290 phase2 / phase3completednot on this map

A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS

TypeinterventionalSponsorBioNTech SERan2023 to 2025Enrolled1,051ConditionsSARS-CoV-2 Infection, COVID-19ArmsBNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
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

21 authors.

Oyeniyi DiyaVaccine Research and Development, Pfizer Ltd, Marlow, UK.
Juleen GayedVaccine Research and Development, Pfizer Ltd, Marlow, UK. juleen.gayed@pfizer.com.ORCID http://orcid.org/0009-0004-2974-5302
Francine S LowryVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Hua MaVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Vishva BangadVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Federico MensaBioNTech, Mainz, Germany.
Jing ZouDepartment of Microbiology and Immunology, The University of Texas Medical Branch, Galveston, TX, USA.
Xuping XieDepartment of Microbiology and Immunology, The University of Texas Medical Branch, Galveston, TX, USA.
Yanping HuDepartment of Microbiology and Immunology, The University of Texas Medical Branch, Galveston, TX, USA.
Mark CutlerVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Todd BelangerVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
David CooperVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Xia XuVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Robin MoggVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Özlem TüreciBioNTech, Mainz, Germany.
Uǧur ŞahinBioNTech, Mainz, Germany.
Kena A SwansonVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Kayvon ModjarradVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Annaliesa S AndersonVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Alejandra GurtmanVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Nicholas KitchinVaccine Research and Development, Pfizer Ltd, Marlow, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCOVID-19 continues to cause substantial health burden, particularly among vulnerable populations. Vaccines remain a vital tool in preventing severe disease outcomes. As the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve; therefore, updates may be needed to closely match COVID-19 vaccine composition to predominant circulating lineages to confer optimal protection.

methodsIn this cohort from a substudy of an ongoing phase 2/3 trial, 102 healthy adults (18‒55 and > 55 years of age, n = 51 each) were vaccinated with Omicron KP.2-adapted BNT162b2. Serum neutralizing titers against Omicron KP.2, JN.1, and KP.3 were assessed before and through 1 month after vaccination. Immunogenicity in KP.2-adapted BNT162b2 recipients was compared with participants who received JN.1-adapted BNT162b2 in an earlier cohort of this substudy. Local reactions and systemic events through 7 days and adverse events (AEs) through 1 month are reported.

resultsOne month after vaccination, KP.2-adapted BNT162b2-elicited neutralizing titers against Omicron KP.2, JN.1, and KP.3 were numerically higher than those induced by JN.1-adapted BNT162b2. Geometric mean fold rises from before to 1 month after vaccination were numerically higher in those who received KP.2-adapted BNT162b2 compared with those who received JN.1-adapted BNT162b2 (9.4 vs. 6.8 for KP.2; 7.8 vs. 5.7 for JN.1; 9.2 vs. 7.0 for KP.3). Percentages of participants with seroresponses were numerically higher against KP.2 after KP.2-adapted BNT162b2 than JN.1-adapted BNT162b2 (75% vs. 65%) and similar against JN.1 and KP.3 for both vaccines (69% vs. 67% for JN.1; 74% vs. 73% for KP.3). Local reactions and systemic events were all mild to moderate in severity, AEs were infrequent, and no serious AEs or AEs leading to withdrawal were reported.

conclusionsCollectively, these immunogenicity, safety, and tolerability data support administration of KP.2-adapted BNT162b2 to protect against contemporaneous circulating lineages. CLINICALTRIALS: GOV IDENTIFIER: NCT05997290.

Indexed as

BNT162b2BoosterCOVID-19LineageOmicron KP.2SARS-CoV-2 vaccineSublineageVariant adapted

Identifiers

PMID40591130
PMCPMC12339817

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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.