Trial reportThe New England journal of medicine2020
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.
2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1,644 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
1,644citing papers in PubMed, 1 pooled it
58.7field-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 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of sars-cov-2 rna vaccine candidates against covid-19 in healthy individuals
Serology Testing (Antibody Levels) With Time Following SARS-CoV-2 (Covid-19) Vaccinations in Residents of Nursing, Extended Care, and Over-55 Communities
Who cites it
1,644 citing papers in PubMed, 1 synthesis or guideline pooled it, 2,701 citations in OpenAlex.
- A Meta-Analysis on the Immunogenicity of Homologous versus Heterologous Immunization Regimens against SARS-CoV-2 Beta, Delta, and Omicron BA.1 VoCs in Healthy Adults.Journal of microbiology and biotechnology · 2025Pooled it
- Safety and Immunogenicity of BNT162b2 in Antiretroviral Therapy-Treated People With HIV.Open forum infectious diseases · 2026Trial
- Safety, immunogenicity, persistence and dose evaluation of the CS-2034 mRNA COVID-19 vaccine: a phase II randomized controlled trial in healthy Chinese adults.BMC infectious diseases · 2025Trial
- Safety and immunogenicity of an optimized self-replicating RNA platform for low dose or single dose vaccine applications: a randomized, open label Phase I study in healthy volunteers.Nature communications · 2025Trial
- Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study.Human vaccines & immunotherapeutics · 2024Trial
- Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials.Nature communications · 2024Trial
- Receptor binding domain-independent pancoronavirus vaccine design by fusion of conserved T/B Epitopes.Emerging microbes & infections · 2026Article
- Effects of natural killer cell depletion on innate and adaptive immune responses to COVID mRNA vaccination.Journal of immunology (Baltimore, Md. : 1950) · 2026Article
- 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
- Comparative analysis of clinically approved lipid nanoparticles for intranasal siRNA delivery against SARS-CoV-2.Drug delivery and translational research · 2026Article
- mRNA Vaccines Targeting the Conserved SARS-CoV-2 Fusion Machinery Elicit Cross-Variant and Robust Immunity.Vaccines · 2026Article
- Long-Term Humoral Immune Dynamics in Healthcare Workers with Hybrid and Vaccine-Induced Immunity: The VaCoMRI Study.Viruses · 2026Article
- Multifunctional antibody responses from a primateScience translational medicine · 2026Article
- A predictive model for rapid assessment of protective efficacy against emerging SARS-CoV-2 variants.Infectious Disease Modelling · 2026Article
- RNA delivery to the corneal endothelium using charge-altering releasable transporters.Science advances · 2026Article
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- An In Vitro Screen Identifies H1 Influenza Hemagglutinin Substitutions That Alter mRNA-LNP Vaccine Responses Against the Stalk Domain.Vaccines · 2026Article
- Persistent SARS-CoV-2 Spike Protein in Vasculitic Skin Lesions after Infection or mRNA Vaccination: A Retrospective Case control Immunofluorescence Study.Acta dermato-venereologica · 2026Article
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- Novel Recruitment, Data Collection, and Safety Reporting Methods in the Era of COVID-19: Design of a Post-Emergency Use Authorization COVID-19 Vaccination Safety-Surveillance Study.Pharmacoepidemiology and drug safety · 2026Observational
1,584 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
25 authors at 1 institution in 1 country.
Edward E WalshFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Robert W FrenckFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Ann R FalseyFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Nicholas KitchinFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Judith AbsalonFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Alejandra GurtmanFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Stephen LockhartFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kathleen NeuzilFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Mark J MulliganFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Ruth BaileyFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kena A SwansonFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Ping LiFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kenneth KouryFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Warren KalinaFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
David CooperFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Camila Fontes-GarfiasFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Pei-Yong ShiFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Özlem TüreciFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kristin R TompkinsFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kirsten E LykeFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Vanessa RaabeFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Philip R DormitzerFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Kathrin U JansenFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
Uğur ŞahinFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
William C GruberFrom the University of Rochester and Rochester General Hospital, Rochester (E.E.W., A.R.F.), Vaccine Research and Development, Pfizer, Pearl River (J.A., A.G., K.A.S., K.K., W.K., D.C., K.R.T., P.R.D., K.U.J., W.C.G.), and New York University Langone Vaccine Center and Grossman School of Medicine, New York (M.J.M., V.R.) - all in New York; Cincinnati Children's Hospital, Cincinnati (R.W.F.); Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., R.B.); the University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore (K.N., K.E.L.); Vaccine Research and Development, Pfizer, Collegeville, PA (P.L.); the University of Texas Medical Branch, Galveston (C.F.-G., P.-Y.S.); and BioNTech, Mainz, Germany (ÖT., U.Ş.).
University of Rochester · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been reported previously from trials in Germany and the United States.
methodsIn an ongoing, placebo-controlled, observer-blinded, dose-escalation, phase 1 trial conducted in the United States, we randomly assigned healthy adults 18 to 55 years of age and those 65 to 85 years of age to receive either placebo or one of two lipid nanoparticle-formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain; or BNT162b2, which encodes a membrane-anchored SARS-CoV-2 full-length spike, stabilized in the prefusion conformation. The primary outcome was safety (e.g., local and systemic reactions and adverse events); immunogenicity was a secondary outcome. Trial groups were defined according to vaccine candidate, age of the participants, and vaccine dose level (10 μg, 20 μg, 30 μg, and 100 μg). In all groups but one, participants received two doses, with a 21-day interval between doses; in one group (100 μg of BNT162b1), participants received one dose.
resultsA total of 195 participants underwent randomization. In each of 13 groups of 15 participants, 12 participants received vaccine and 3 received placebo. BNT162b2 was associated with a lower incidence and severity of systemic reactions than BNT162b1, particularly in older adults. In both younger and older adults, the two vaccine candidates elicited similar dose-dependent SARS-CoV-2-neutralizing geometric mean titers, which were similar to or higher than the geometric mean titer of a panel of SARS-CoV-2 convalescent serum samples.
conclusionsThe safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2-3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.).
Indexed as
AdolescentAdultAgedAged, 80 and overAntibodies, ViralBNT162 VaccineCOVID-19COVID-19 VaccinesFemaleHumansInjections, IntramuscularMaleMiddle AgedNeutralization TestsSARS-CoV-2Single-Blind MethodAntibodies, ViralBNT162 VaccineCOVID-19 VaccinesSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2
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Registered trials
NCT04368728ClinicalTrials.gov
NCT04944095ClinicalTrials.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.