Trial reportThe New England journal of medicine2023
Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph
Trial report in The New England journal of medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04955626 (A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE), which is not on this map. Cited by 67 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 pooled it
23.3field-weighted citation impact, top 1% of its field
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.
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.
A phase 3 master protocol to evaluate additional dose(s) of bnt162b2 in healthy individuals previously vaccinated with bnt162b2
Who cites it
67 citing papers in PubMed, 2 syntheses or guidelines pooled it, 120 citations in OpenAlex.
- Comparing the Efficacy and Adverse Events of Available COVID-19 Vaccines Through Randomized Controlled Trials: Updated Systematic Review and Network Meta-analysis.Journal of research in health sciences · 2023Pooled it
- Relative effectiveness of bivalent COVID-19 vaccine: a systematic review and meta-analysis.Frontiers in medicine · 2023Pooled it
- Safety and Immunogenicity of a Fourth Dose of Omicron BA.1-Adapted BNT162b2 COVID-19 Vaccines in Adults 18-55 Years Old.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Antibody and T-Cell Response to Bivalent Booster SARS-CoV-2 Vaccines in People With Compromised Immune Function: COVERALL-3 Study.The Journal of infectious diseases · 2024Trial
- Original COVID-19 priming regimen impacts the immunogenicity of bivalent BA.1 and BA.5 boosters.Nature communications · 2024Trial
- A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial.Nature medicine · 2024Trial
- Immunogenicity of the BA.1 and BA.4/BA.5 Severe Acute Respiratory Syndrome Coronavirus 2 Bivalent Boosts: Preliminary Results From the COVAIL Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- Safety and immunogenicity of a modified Omicron-adapted inactivated vaccine in healthy adults: a randomized, double-blind, active-controlled Phase III clinical trial.Frontiers in immunology · 2023Trial
- Immunogenicity, Tolerability, and Safety of BA.1-Adapted BNT162b2 Vaccine in 18- to 55-Year-Olds Previously Vaccinated with BNT162b2 or Who Were COVID-19 Vaccine-Naive.Infectious diseases and therapy · 2026Article
- Article
- Article
- Article
- Immunogenicity and Breakthrough Outcomes of mRNA Booster Strategies Among Healthcare Workers During the BA.1/BA.2 Omicron Surge.Microorganisms · 2025Article
- Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025Review
- Safety and Immunogenicity of Monovalent Omicron KP.2-Adapted BNT162b2 COVID-19 Vaccine in Adults: Single-Arm Substudy from a Phase 2/3 Trial.Infectious diseases and therapy · 2025Article
- Article
- Review
- Phylogeny-driven design of broadly protective sarbecovirus receptor-binding domain nanoparticle vaccines.bioRxiv : the preprint server for biology · 2025Article
- Article
7 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
30 authors at 1 institution in 2 countries.
Patricia WinokurFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Juleen GayedFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
David Fitz-PatrickFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Stephen J ThomasFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Oyeniyi DiyaFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Stephen LockhartFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Xia XuFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Ying ZhangFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Vishva BangadFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Howard I SchwartzFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Douglas DenhamFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Jose F CardonaFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Lisa UsdanFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
John GinisFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Federico J MensaFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Jing ZouFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Xuping XieFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Pei-Yong ShiFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Claire LuFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Sandra BuitragoFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Ingrid L ScullyFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
David CooperFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Kenneth KouryFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Kathrin U JansenFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Özlem TüreciFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Uğur ŞahinFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Kena A SwansonFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).ORCID 0000-0002-3389-8414
William C GruberFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
Nicholas KitchinFrom the Division of Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City (P.W.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (J. Gayed, O.D., S.L., N.K.); East-West Medical Research Institute, Honolulu (D.F.-P.); the State University of New York, Upstate Medical University, Syracuse (S.J.T.), and Vaccine Research and Development, Pfizer, Pearl River (Y.Z., C.L., S.B., I.L.S., D.C., K.K., K.U.J., K.A.S., W.C.G.) - both in New York; Vaccine Research and Development, Pfizer, Collegeville, PA (X. Xu, V.B., J. Ginis); CenExel RCA, Hollywood (H.I.S.), and Indago Research and Health Center, Hialeah (J.F.C.) - both in Florida; Clinical Trials of Texas, San Antonio (D.D.), and the University of Texas Medical Branch, Galveston (J.Z., X. Xie, P.-Y.S.) - both in Texas; CNS Healthcare, Memphis, TN (L.U.); and BioNTech, Mainz, Germany (F.J.M., Ö.T., U.Ş.).
C4591031 Clinical Trial Group
SUNY Upstate Medical University · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe emergence of immune-escape variants of severe acute respiratory syndrome coronavirus 2 warrants the use of sequence-adapted vaccines to provide protection against coronavirus disease 2019.
methodsIn an ongoing phase 3 trial, adults older than 55 years who had previously received three 30-μg doses of the BNT162b2 vaccine were randomly assigned to receive 30 μg or 60 μg of BNT162b2, 30 μg or 60 μg of monovalent B.1.1.529 (omicron) BA.1-adapted BNT162b2 (monovalent BA.1), or 30 μg (15 μg of BNT162b2 + 15 μg of monovalent BA.1) or 60 μg (30 μg of BNT162b2 + 30 μg of monovalent BA.1) of BA.1-adapted BNT162b2 (bivalent BA.1). Primary objectives were to determine superiority (with respect to 50% neutralizing titer [NT
resultsA total of 1846 participants underwent randomization. At 1 month after vaccination, bivalent BA.1 (30 μg and 60 μg) and monovalent BA.1 (60 μg) showed neutralizing activity against BA.1 superior to that of BNT162b2 (30 μg), with NT
conclusionsThe candidate monovalent or bivalent omicron BA.1-adapted vaccines had a safety profile similar to that of BNT162b2 (30 μg), induced substantial neutralizing responses against ancestral and omicron BA.1 strains, and, to a lesser extent, neutralized BA.4, BA.5, and BA.2.75 strains. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04955626.).
Indexed as
BNT162 VaccineCOVID-19SARS-CoV-2Vaccines, CombinedAntibodies, NeutralizingAntibodies, ViralHumansMiddle AgedVaccinationAntibodies, NeutralizingAntibodies, ViralBNT162 VaccineVaccines, Combined
Identifiers
What OpenQuestion holds
Textmetadata
Read underepoch 390
Registered trials
NCT04955626ClinicalTrials.gov
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.