Created at Source Raw Value Validated value
Nov. 4, 2022, 8 a.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSC - the immune response to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age and a third dose of BNT162b2 30 µg in a randomly selected subset of participants 18 through 55 years of age from study C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only);SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSC - the immune response to BNT162b2 10 µg and 30 µg given as the third dose in participants 12 through 17 years of age and a third dose of BNT162b2 30 µg in a randomly selected subset of participants 18 through 55 years of age from study C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only);SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

July 21, 2022, 12:30 p.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in age-matched participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only);SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in age-matched participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Noninferiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Percentage of participants with elevated troponin I levels (18-55 years of age, sentinel cohort only);SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of bivalent BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSE - Superiority of neutralizing titer after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants >55 years of age;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

May 12, 2022, 6:30 a.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in age-matched participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose BNT162b2 OMI compared to after 1 dose BNT162b2 given as the D4 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titer and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 2 doses BNT162b2 OMI compared to after 2 doses BNT162b2 in age-matched participants from the C4591001 study;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse of anti-Omi immune response after 2 doses BNT162b2 OMI given as D3+D4 compared to after 1 dose BNT162b2 given as D3 in BNT162b2-experienced participants;SSD-Superiority with respect to neutralizing titers and noninferiority with respect to seroresponse rate of the anti-Omi immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as D3 in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

April 7, 2022, 9:30 p.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants;SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants;SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - For each of the 2 age groups (12 through 17, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 30 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - For each of the 4 age groups (12 through 17, 18 through 30, 31 through 55, and ≥56 years of age): Demonstrate immunobridging of immune response of D3 of BNT162b2 at 10 µg compared to after D2 in age-matched participants from the C4591001 study;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the fourth dose in BNT162b2-experienced participants;SSD - The superiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants;SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - The superiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI given as the third and fourth doses compared to after 1 dose of BNT162b2 given as the third dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

March 3, 2022, 8:30 p.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Noninferiority of anti-OMI immune response after D1 of BNT162b2 OMI as D3 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI given as the fourth dose compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after the fourth dose of BNT162b2 compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-OMI immune response after D2 of BNT162b2 OMI as D3 and D4 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after D2 of BNT162b2 in age-matched participants from C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Noninferiority of anti-OMI immune response after D1 of BNT162b2 OMI as D3 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI given as the fourth dose compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after the fourth dose of BNT162b2 compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-OMI immune response after D2 of BNT162b2 OMI as D3 and D4 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after D2 of BNT162b2 in age-matched participants from C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events;SSE - Noninferiority of anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-Omicron immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of anti-reference-strain immune responses after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Noninferiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Percentage of participants reporting adverse events;SSE - Percentage of participants reporting local reactions;SSE - Percentage of participants reporting serious adverse events;SSE - Percentage of participants reporting systemic events;SSE - Superiority of anti-Omicron immune response after 1 dose of BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of anti-reference-strain immune responses after 1 dose of BNT162b2 at 60 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-Omicron immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 30 µg compared to after 1 dose of BNT162b2 OMI at 30 µg given as a fourth dose in BNT162b2-experienced participants;SSE - Superiority of the anti-reference-strain immune response after 1 dose of a combination of BNT162b2 and BNT162b2 OMI at 60 µg compared to after 1 dose of BNT162b2 OMI at 60 µg given as a fourth dose in BNT162b2-experienced participants;SSF - Percentage of participants reporting adverse events;SSF - Percentage of participants reporting local reactions;SSF - Percentage of participants reporting serious adverse events;SSF - Percentage of participants reporting systemic events;SSF - To describe the immune response to BNT162b2 (30 µg or 60 µg), BNT162b2 OMI (30 µg or 60 µg), and a combination of BNT162b2 and BNT162b2 OMI (30 µg or 60 µg) given as a fourth dose in BNT162b2-experienced participants

Feb. 9, 2022, 3 p.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Noninferiority of anti-OMI immune response after D1 of BNT162b2 OMI as D3 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI given as the fourth dose compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after the fourth dose of BNT162b2 compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-OMI immune response after D2 of BNT162b2 OMI as D3 and D4 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after D2 of BNT162b2 in age-matched participants from C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events;SSD - Noninferiority of anti-OMI immune response after D1 of BNT162b2 OMI as D3 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after 1 dose of BNT162b2 OMI given as the fourth dose compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-Omicron immune response after 2 doses of BNT162b2 OMI compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in age-matched participants randomly selected from the C4591001 study;SSD - Noninferiority of the anti-Omicron immune response after the fourth dose of BNT162b2 compared to the anti-reference-strain immune response after 2 doses of BNT162b2 in the same set of participants;SSD - Noninferiority of the anti-OMI immune response after D2 of BNT162b2 OMI as D3 and D4 in BNT162b2-experienced participants compared to the anti-reference-strain immune response after D2 of BNT162b2 in age-matched participants from C4591001;SSD - Percentage of participants reporting adverse events;SSD - Percentage of participants reporting local reactions;SSD - Percentage of participants reporting serious adverse events;SSD - Percentage of participants reporting systemic events

Dec. 19, 2021, 2:30 a.m. usa

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events

SSA - Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;SSA - Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;SSA - Percentage of participants reporting adverse events;SSA - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting adverse events;SSB - Percentage of participants reporting local reactions;SSB - Percentage of participants reporting serious adverse events;SSB - Percentage of participants reporting systemic events;SSB - Percentage of participants with elevated troponin I levels;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 10 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a booster (third) dose of BNT162b2 at 30 µg compared to after the second dose in the same set of participants 12 through 17 years of age without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 18 to 30 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants 31 to 55 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 10 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Demonstrate immunobridging of immune response of a third dose of BNT162b2 at 30 µg in participants ≥56 years of age compared to after the second dose in age-matched participants from the C4591001 study, without evidence of SARS-CoV-2 infection;SSC - Percentage of participants reporting adverse events;SSC - Percentage of participants reporting local reactions;SSC - Percentage of participants reporting serious adverse events;SSC - Percentage of participants reporting systemic events

July 14, 2021, 6 a.m. usa

Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;Percentage of participants reporting adverse events;Percentage of participants reporting serious adverse events

Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;Percentage of participants reporting adverse events;Percentage of participants reporting serious adverse events