Epub 2020 Aug 12. Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. The book recommends changes to the Advisory Committee on Immunization Practices (ACIP)-the entity that currently recommends vaccines-and calls for a series of public meetings, a post-implementation evaluation study, and development of a ... Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Numbers of hospitalizations and deaths for COVID-19 in … Coronavirus disease (COVID-19) mass vaccination has been a chief priority for health systems globally, which needs to be accelerated in order to control the acute phase of the pandemic [1,2].Nevertheless, vaccine hesitancy (VH)—which refers to the "delay in acceptance or refusal of vaccines despite the availability of vaccine services"—remains a serious challenge for . Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Numbers of hospitalizations and deaths for COVID-19 in comparison to varicella, rubella, hepatitis A, and rotavirus in pre-vaccine era* Virus Hospitalizations/year Deaths COVID-19 19.4 per 100,000 age 0-4 yrs 11.4 per 100,000 age 5 -17 yrs This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of screening. Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The U.S. Food and Drug Administration . Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. The COVID-19 Vaccine Working Group on Pediatric Oncology convened in early March 2021 to answer vaccine questions. The American Academy of Pediatrics, which represents 67 000 primary care and specialist paediatricians, urged the Food and Drug Administration to work "aggressively toward authorising safe and effective covid-19 vaccines for children under age 12 as soon as possible.". The national study is a Phase 1/2/3, randomized, placebo-controlled, observer . August 11, 2021; 2:41 PM EDT (Reuters) - Moderna Inc is planning to double the size of an ongoing trial testing its COVID-19 vaccines in children aged six months to less than 12 years.. Developing a pediatric COVID-19 vaccine could prevent disease, mitigate downstream effects and enable children to re-engage in their world. Information provided by (Responsible Party): Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. Clinical signs indicative of symptomatic COVID-19 as predefined for the study. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The ACIP COVID-19 Vaccines Work Group, comprising experts in infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings since April 2020 to review COVID-19 surveillance data, evidence for vaccine efficacy and safety, and implementation considerations for COVID-19 vaccination programs. The availability of the COVID 19 vaccine has been widely anticipated, yet not all individuals will seek the vaccine. FDA Approves First COVID-19 Vaccine. Rady Children's Health Network is partnering with the Altman Clinical and Translational Research Institute and the Mother-Child-Adolescent Program at UC San Diego to study the safety and effectiveness of Moderna's COVID-19 vaccine for children. Halfpoint/iStock(NEW YORK) -- The United States is facing a COVID-19 surge this summer as the more contagious delta variant spreads. This is a comprehensive textbook of Hodgkin's and non-Hodgkin's lymphomas written by leaders in the field of childhood lymphomas. It includes clinical, pathologic and molecular biology of each subtype of lymphoma. For general information, Learn About Clinical Studies. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Johnson & Johnson's Janssen. UPMC Children's Hospital of Pittsburgh is enrolling children ages 6 months to 12 years in a pediatric COVID-19 vaccine trial. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. You have reached the maximum number of saved studies (100). Pfizer. Receipt of medications intended to prevent COVID 19. The review of this product was associated with the following … About Study Results Reporting on ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Clinical signs indicative of SARS-CoV-2 infection as predefined for the study. Please access http://TeenCoveStudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study. COVID-19 vaccines cannot give you COVID-19. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Farenheit. Epub 2020 Oct 14. Walsh EE, Frenck RW Jr, Falsey AR, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Mulligan MJ, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Lyke KE, Raabe V, Dormitzer PR, Jansen KU, Şahin U, Gruber WC. a free Pfizer COVID-19 vaccine, even if they don't have insurance and regardless of their immigration status. Nonchildbearing potential is defined as premenarche or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy). 3 Pediatric Vaccine Clinical Trials • Sponsors have decades of experience collaborating with FDA on pediatric vaccine clinical trials. Emmanuel (Chip) B. Walter, MD, MPH, pediatric infectious diseases specialist, is principal investigator on a clinical trial for a SARS-COV-2 (COVID-19) vaccine.Geeta Swamy, MD, maternal-fetal medicine specialist, is co-investigator.Recruitment is now underway for vaccine candidate selection among healthy adults. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649151. Overview of the Moderna Pediatric COVID-19 Vaccine Study. Also available are the "Inventario II: Palabras y Enunciados" and the "User's Guide and Technical Manual." These forms are part of the "MacArthur-Bates Inventarios del Desarrollo de Habilidades Comunicativas (Inventarios). Moderna. Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. 2021 Apr;592(7853):283-289. doi: 10.1038/s41586-021-03275-y. Investigator assessment that the participant, in the case of an emancipated minor, or parent(s)/legally acceptable representative(s) [LAR(s)] understand and is willing and physically able to comply with protocol-mandated follow up, including all procedures and provides written informed consent/assent. Biomedical Advanced Research and Development Authority. Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi PY, Türeci Ö, Tompkins KR, Walsh EE, Frenck R, Falsey AR, Dormitzer PR, Gruber WC, Şahin U, Jansen KU. Trials of coronavirus disease 2019 (COVID-19) vaccination included limited numbers of children, so they may not have detected rare but important adverse events in this population. Choosing to participate in a study is an important personal decision. Capable of giving personal signed informed consent. Massachusetts General Hospital is participating in a number of local, regional and national … Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. Clinical trials will be conducted at Rady . Moderna doubles size of COVID-19 vaccine pediatric study. Once vaccines are available for children under the age of 16 years, this long-standing pediatric management issue may again emerge and impact public health. Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥20 mg/day prednisone equivalent). For general information, Learn About Clinical Studies. Pfizer is now conducting a clinical trial in children down to age 6 months. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Jaime G. Deville, M.D., a pediatrician at the David Geffen School of Medicine at UCLA, was one of the reviewers who approved the protocol for the Phase 3 Pfizer and Moderna mRNA vaccine clinical trials for COVID-19. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. Why Should I Register and Submit Results? Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each dose) ], Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each dose) ], Number of Participants with Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), or Adverse Events of Special Interest (AESI) of Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 394 (1 year after second dose) ], Number of Participants With Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection From COVID-19 [ Time Frame: Day 57 (28 days after second dose) ], Geometric Mean (GM) of the Serum Ab Level [ Time Frame: Day 57 (28 days after second dose) ], Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (28 days after second dose) ], GM of SARS-CoV-2 Spike Protein (S2P)-Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2) ], GM of SARS-CoV-2-Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 57 (1 month after dose 2), Day 209 (6 months after dose 2), and Day 394 (1 year after dose 2) ], Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) Starting 14 Days after the Second Dose of mRNA-1273 or Placebo [ Time Frame: Day 43 up to Day 394 ], Number of Participants With Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein [ Time Frame: Day 43 up to Day 394 ], Number of Participants with a First Occurrence of Symptomatic COVID-19 Starting 14 days After Second Dose of mRNA-1273 or Placebo [ Time Frame: Day 43 up to Day 394 ]. (Clinical Trial), Triple (Participant, Care Provider, Investigator), 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, Experimental: 10 µg dose, 18-55 years of age (2 doses), Experimental: 20 µg dose, 18-55 years of age (2 doses), Experimental: 30 µg dose, 18-55 years of age (2 doses), Experimental: 10 µg dose, 65-85 years of age (2 doses), Experimental: 20 µg dose, 65-85 years of age (2 doses), Experimental: 30 µg dose, 65-85 years of age (2 doses), Experimental: 30 µg dose, ≥12 years of age (2 doses), Placebo Comparator: Placebo, 18-55 years of age, Placebo Comparator: Placebo, 65-85 years of age, Placebo Comparator: Placebo, ≥12 years of age, Experimental: 100 µg dose, 18-55 years of age (2 doses), Vaccination of Placebo recipients with BNT162b2 - Stage 1, Vaccination of placebo recipients with BNT162b2 - Stage 2, Experimental: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg, Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg, Experimental: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg, Experimental: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg, Experimental: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg, Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg, Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg, 12 Years and older (Child, Adult, Older Adult), Birmingham, Alabama, United States, 35216, Huntsville, Alabama, United States, 35801, Huntsville, Alabama, United States, 35802, Alliance for Multispecialty Research, LLC, Chinle Comprehensive Health Care Facility, Johns Hopkins Center for American Indian Health, Whiteriver, Arizona, United States, 85941, Anaheim, California, United States, 92801, Long Beach, California, United States, 90806, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 90027, Los Angeles, California, United States, 90057, North Hollywood, California, United States, 91606, Redding, California, United States, 96001, Sacramento, California, United States, 95815, Sacramento, California, United States, 95817, San Diego, California, United States, 92123-1881, Santa Clara, California, United States, 95051, Valley Village, California, United States, 91607, Walnut Creek, California, United States, 94598, Milford, Connecticut, United States, 06460, Yale Center for Clinical Investigations (CSRU), New Haven, Connecticut, United States, 06519, Alliance for Multispecialty Research, LLC-Miami, Coral Gables, Florida, United States, 33134, Fleming Island Center for Clinical Research, Fleming Island, Florida, United States, 32003, Jacksonville Center for Clinical Research, Jacksonville, Florida, United States, 32216, Jacksonville, Florida, United States, 32256, Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Stockbridge, Georgia, United States, 30281, University of Iowa Hospitals & Clinics Investigational Drug Servces, Bardstown, Kentucky, United States, 40004, Metairie, Louisiana, United States, 70006, New Orleans, Louisiana, United States, 70121, Shreveport, Louisiana, United States, 71101, Shreveport, Louisiana, United States, 71103, Baltimore, Maryland, United States, 21201, University of Maryland Medical Center Investigational Drug Service Pharmacy, University of Maryland, Baltimore, Health Sciences Research Facility III, University of Maryland, Center for Vaccine Development and Global Health, Center for Immunization Research Inpatient Unit, Baltimore, Maryland, United States, 21224, Boston, Massachusetts, United States, 02118, UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States, 01655, Farmington Hills, Michigan, United States, 48334, Gulfport, Mississippi, United States, 39503, Chesterfield, Missouri, United States, 63005, Saint Louis, Missouri, United States, 63141, Bozeman Health Deaconess Hospital dba Bozeman Health Clinical Research, Methodist Physicians Clinic / CCT Research, Wake Research-Clinical Research Center of Nevada, LLC, Raritan, New Jersey, United States, 08869, Somers Point, New Jersey, United States, 08244, Shiprock, New Mexico, United States, 87420, Binghamton, New York, United States, 13901, Rochester, New York, United States, 14609, Rochester Regional Health/Rochester General Hospital, Rochester, New York, United States, 14621, Cary, North Carolina, United States, 27518, Charlotte, North Carolina, United States, 28209, Durham, North Carolina, United States, 27705, Durham, North Carolina, United States, 27710, Duke University Medicine Circle- Duke Early Phase Clinical Research Unit, Greensboro, North Carolina, United States, 27408, Hickory, North Carolina, United States, 28601, Raleigh, North Carolina, United States, 27609, Raleigh, North Carolina, United States, 27612, Salisbury, North Carolina, United States, 28144, Wilmington, North Carolina, United States, 28401, Winston-Salem, North Carolina, United States, 27103, Fargo, North Dakota, United States, 58104, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229-3039, University Hospitals Cleveland Medical Center, Kaiser Permanente Northwest-Center for Health Research, Lehigh Valley Health Network/Network Office of Research and Innovation, Allentown, Pennsylvania, United States, 18102, Warwick, Rhode Island, United States, 02886, Little River, South Carolina, United States, 29566, Loris, South Carolina, United States, 29569, Kingsport, Tennessee, United States, 37660, Knoxville, Tennessee, United States, 37909, Knoxville, Tennessee, United States, 37920, Nashville, Tennessee, United States, 37203, Tullahoma, Tennessee, United States, 37388. Part A (Blinded Phase): Participants will receive 2 intramuscular (IM) injections of mRNA-1273 (100 microgram [ug] each), 28 days apart, on Day 1 and Day 29. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Learn more to bust myths and learn the facts about COVID-19 vaccines. Phase 1 is the open-label dose-finding portion of the study to evaluate safety, tolerability, and immunogenicity of BNT162b2 on a 2-dose (separated by approximately 21 … 0. comments. Found inside13 https://clinicaltrials.gov/ 14 https://www.statistics/732804/top-clinical-research-organizations-by-revenue/ 15 Marcia Angell, ... 22 https://www.cnn.com/2020/07/22/health/pfizer-covid-19-vaccine-government-contract/index.html 23 ... 713-798-4710. Accelerated vaccine development and approval did not sacrifice scientific standards or the integrity of the FDA evaluation process. The agency first authorized the vaccine for emergency use in this age group in December after clinical trials showed it was safe and effective for at least two months. 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov . Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). Once vaccines are available for children … U.S. Department of Health and Human Services. Vogel AB, Kanevsky I, Che Y, Swanson KA, Muik A, Vormehr M, Kranz LM, Walzer KC, Hein S, Güler A, Loschko J, Maddur MS, Ota-Setlik A, Tompkins K, Cole J, Lui BG, Ziegenhals T, Plaschke A, Eisel D, Dany SC, Fesser S, Erbar S, Bates F, Schneider D, Jesionek B, Sänger B, Wallisch AK, Feuchter Y, Junginger H, Krumm SA, Heinen AP, Adams-Quack P, Schlereth J, Schille S, Kröner C, de la Caridad Güimil Garcia R, Hiller T, Fischer L, Sellers RS, Choudhary S, Gonzalez O, Vascotto F, Gutman MR, Fontenot JA, Hall-Ursone S, Brasky K, Griffor MC, Han S, Su AAH, Lees JA, Nedoma NL, Mashalidis EH, Sahasrabudhe PV, Tan CY, Pavliakova D, Singh G, Fontes-Garfias C, Pride M, Scully IL, Ciolino T, Obregon J, Gazi M, Carrion R Jr, Alfson KJ, Kalina WV, Kaushal D, Shi PY, Klamp T, Rosenbaum C, Kuhn AN, Türeci Ö, Dormitzer PR, Jansen KU, Sahin U. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. GAITHERSBURG, Md., May 3, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company's recombinant protein vaccine candidate against COVID-19.The additional arm of the ongoing PREVENT-19 . Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. The American Academy of Pediatrics and the CDC have independently reviewed the data and the FDA's decision, and recommend vaccination for everyone 12 years of age and older. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 1 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 day after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 1 ], Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values [ Time Frame: 7 days after dose 2 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 day after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 7 days after dose 1 ], Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between before dose 2 and 7 days after dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], Percentage of participants 12-15 years of age in Phase 3 reporting adverse events [ Time Frame: From dose 1 through 6 months after the last dose ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ], In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 and dose 2 ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events [ Time Frame: From dose 1 through 1 month after the last dose ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events [ Time Frame: From dose 1 through 5 or 6 months after the last dose ], In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 (and dose 2) ], In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events [ Time Frame: For 7 days after dose 1 (and dose 2) ], In participants who receive a third dose of BNT162b2, percentage of participants reporting adverse events [ Time Frame: From the third dose through 1 month after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting serious adverse events [ Time Frame: From the third dose through 6 months after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting local reactions [ Time Frame: For 7 days after the third dose ], In participants who receive a third dose of BNT162b2, percentage of participants reporting systemic events [ Time Frame: For 7 days after the third dose ], Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ], In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs [ Time Frame: Through 2 years after the final dose ], Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point [ Time Frame: Through 2 years after the final dose ], In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels [ Time Frame: Through 2 years after the final dose ], Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 7 days after the second dose of study intervention to the end of the study, up to 2 years ], Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination [ Time Frame: From 14 days after the second dose of study intervention to the end of the study, up to 2 years ], GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) [ Time Frame: 1 month after the second dose ], Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose [ Time Frame: Through 1 month after the second dose ], Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection [ Time Frame: Through 6 months after the second dose ], Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ], Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the first dose of BNT162b2SA ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg [ Time Frame: 1 month after the first dose of BNT162b2SA/third dose of BNT162b2 ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the second dose of BNT162b2SA ], Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ], Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ]. 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