Trial reportThe New England journal of medicine2022
Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine.
Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2022. 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 216 papers, 7 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
216citing papers in PubMed, 7 pooled it
32.5field-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
216 citing papers in PubMed, 7 syntheses or guidelines pooled it, 326 citations in OpenAlex.
- Efficacy of novel SARS-CoV2 vaccines in preventing SARS- CoV- 2 infection: a systematic review and meta-analysis.BMC infectious diseases · 2025Pooled it
- A meta-analysis of vaccine efficacy from phase III clinical trials of approved vaccines against SARS-CoV-2 and variants.BMC infectious diseases · 2025Pooled it
- COVID-19 Vaccine Effectiveness of Booster Doses Against Delta and Omicron Variants Over Follow-up Times Using Longitudinal Meta-analysis.Journal of research in health sciences · 2024Pooled it
- Pooled it
- 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
- Attenuated immunogenicity of SARS-CoV-2 vaccines and risk factors in stem cell transplant recipients: a meta-analysis.Blood advances · 2023Pooled it
- Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023Pooled it
- Real-world evaluation of 2023-2024 XBB.1.5 mRNA and protein-based COVID-19 vaccine reactogenicity from the randomized BEEHIVE trial.Human vaccines & immunotherapeutics · 2026Trial
- 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
- Heterologous RBMRNA-405 mRNA booster enhances humoral immunity post-inactivated COVID-19 vaccination: a randomized clinical trial in adults and older through 12 months.Scientific reports · 2026Trial
- Efficacy of the tetravalent protein COVID-19 vaccine, SCTV01E: a phase 3 double-blind, randomized, placebo-controlled trial.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
- Dosing of Convalescent Plasma and Hyperimmune Anti-SARS-CoV-2 Immunoglobulins: A Phase I/II Dose-Finding Study.Clinical pharmacokinetics · 2024Trial
- Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults.Nature communications · 2023Trial
- Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds.Journal of the Pediatric Infectious Diseases Society · 2023Trial
- Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age.The New England journal of medicine · 2023Trial
- Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years.The New England journal of medicine · 2023Trial
- Colorectal cancer and tumor vaccines (Review).Oncology letters · 2026Review
- 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
- Pulmonary Delivery of Self-Amplifying RNA: Balancing Inflammation and Durable Transgene Expression.ACS nano · 2026Article
156 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
33 authors at 1 institution in 1 country.
Edson D MoreiraFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Nicholas KitchinFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Xia XuFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Samuel S DychterFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Stephen LockhartFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Alejandra GurtmanFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).ORCID 0000-0003-3469-1201
John L PerezFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Cristiano ZerbiniFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Michael E DeverFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Timothy W JenningsFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Donald M BrandonFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Kevin D CannonFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Michael J KorenFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Douglas S DenhamFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Mezgebe BerheFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
David Fitz-PatrickFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Laura L HammittFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Nicola P KleinFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Haylene NellFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Georgina KeepFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Xingbin WangFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Kenneth KouryFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Kena A SwansonFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).ORCID 0000-0002-3389-8414
David CooperFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Claire LuFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Özlem TüreciFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Eleni LagkadinouFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Dina B TresnanFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Philip R DormitzerFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Uğur ŞahinFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
William C GruberFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
Kathrin U JansenFrom Associação Obras Sociais Irmã Dulce and the Oswaldo Cruz Foundation, Bahia (E.D.M.), and Centro Paulista de Investigação Clinica, São Paulo (C.Z.) - both in Brazil; Vaccine Research and Development, Pfizer, Hurley, United Kingdom (N.K., S.L., G.K.); Vaccine Research and Development, Pfizer, Collegeville, PA (X.X., J.L.P., X.W.); Vaccine Research and Development, Pfizer (S.S.D.), and California Research Foundation (D.M.B.), San Diego, and Kaiser Permanente Vaccine Study Center, Oakland (N.P.K.) - all in California; Vaccine Research and Development, Pfizer, Pearl River, NY (A.G., K.K., K.A.S., D.C., C.L., P.R.D., W.C.G., K.U.J.); Clinical Neuroscience Solutions, Orlando (M.E.D.), and Jacksonville Center for Clinical Research, Jacksonville (M.J.K.) - both in Florida; Clinical Research Professionals, Chesterfield, MO (T.W.J.); Accellacare, Wilmington, NC (K.D.C.); Clinical Trials of Texas, San Antonio (D.S.D.), and North Texas Infectious Diseases Consultants, Dallas (M.B.); East-West Medical Research Institute, Honolulu (D.F.P.); Johns Hopkins Bloomberg School of Public Health, Baltimore (L.L.H.); Tiervlei Trial Centre, Karl Bremer Hospital, Cape Town, South Africa (H.N.); BioNTech, Mainz, Germany (Ö.T., E.L., U.Ş.); and Worldwide Safety, Safety Surveillance and Risk Management, Pfizer, Groton, CT (D.B.T.).
C4591031 Clinical Trial Group
Pfizer (United States) · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundActive immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older.
methodsIn this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose.
resultsA total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3).
conclusionsA third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.).
Indexed as
BNT162 VaccineCOVID-19Immunization, SecondaryCOVID-19 VaccinesHumansPandemicsSARS-CoV-2Treatment OutcomeBNT162 VaccineCOVID-19 Vaccines
Identifiers
What OpenQuestion holds
Textmetadata
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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.