Intensity of SAEs as Per Investigator Assessment;Number of Participants Who Experienced a Fatal SAE;Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity;Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI);Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation;Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE);Number of Participants Who Experienced One or More Serious AE (SAE);Phase 2b Participants Only: Duration of Solicited AEs;Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment;Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment;Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE;Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE

Intensity of SAEs as Per Investigator Assessment;Number of Participants Who Experienced a Fatal SAE;Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity;Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI);Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation;Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE);Number of Participants Who Experienced One or More Serious AE (SAE);Phase 2b Participants Only: Duration of Solicited AEs;Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment;Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment;Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE;Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE

Intensity grading of adverse events of special interest (AESI) as per adapted FDA classification;Intensity grading of medically-attended adverse events (AEs) as per adapted Food and Drug Administration (FDA) classification;Intensity grading of serious adverse events (SAEs) as per adapted FDA classification;Number of participants who experience a fatal serious adverse event (SAE);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience an adverse event (AE) leading to authorized/licensed vaccines withdrawal or trial discontinuation after first dose with an authorized/licensed vaccine for preventing COVID-19 (AV) administered;Number of participants who experience one or more adverse events (AEs) leading to vaccine withdrawal or trial discontinuation;Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Number of participants who experience one or more treatment-related serious adverse events (SAEs);Phase 2b participants only: Duration of solicited local adverse events (AEs);Phase 2b participants only: Duration of solicited systemic adverse events (AEs);Phase 2b participants only: Intensity grading of solicited local adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Intensity grading of solicited systemic adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Intensity grading of unsolicited adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Number of participants who experience one or more solicited local adverse events (AEs);Phase 2b participants only: Number of participants who experience one or more solicited systemic adverse events (AE);Phase 2b participants only: Number of participants who experience one or more treatment-related unsolicited adverse events (AEs);Phase 2b participants only: Number of participants who experience one or more unsolicited adverse events (AEs)

Intensity grading of adverse events of special interest (AESI) as per adapted FDA classification;Intensity grading of medically-attended adverse events (AEs) as per adapted Food and Drug Administration (FDA) classification;Intensity grading of serious adverse events (SAEs) as per adapted FDA classification;Number of participants who experience a fatal serious adverse event (SAE);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience an adverse event (AE) leading to authorized/licensed vaccines withdrawal or trial discontinuation after first dose with an authorized/licensed vaccine for preventing COVID-19 (AV) administered;Number of participants who experience one or more adverse events (AEs) leading to vaccine withdrawal or trial discontinuation;Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Number of participants who experience one or more treatment-related serious adverse events (SAEs);Phase 2b participants only: Duration of solicited local adverse events (AEs);Phase 2b participants only: Duration of solicited systemic adverse events (AEs);Phase 2b participants only: Intensity grading of solicited local adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Intensity grading of solicited systemic adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Intensity grading of unsolicited adverse events (AEs) as per adapted FDA classification;Phase 2b participants only: Number of participants who experience one or more solicited local adverse events (AEs);Phase 2b participants only: Number of participants who experience one or more solicited systemic adverse events (AE);Phase 2b participants only: Number of participants who experience one or more treatment-related unsolicited adverse events (AEs);Phase 2b participants only: Number of participants who experience one or more unsolicited adverse events (AEs)

Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale;Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale;Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale;Number of participants who experience a fatal serious adverse event (SAE);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Number of participants who experience one or more treatment-related serious adverse events (SAEs)

Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale;Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale;Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale;Number of participants who experience a fatal serious adverse event (SAE);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Number of participants who experience one or more treatment-related serious adverse events (SAEs)

Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more treatment-related serious adverse events (SAEs);Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale;Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale;Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of moderate to severe COVID-19;Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience a fatal serious adverse event (SAE);Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale

Number of participants who experience one or more adverse events of special interest (AESI);Number of participants who experience one or more treatment-related serious adverse events (SAEs);Intensity grading of serious adverse events (SAEs) per FDA toxicity grading scale;Number of participants who experience one or more serious adverse events (SAEs);Number of participants who experience one or more treatment-related medically-attended adverse events (AEs);Intensity grading of medically-attended adverse events (AEs) per FDA toxicity grading scale;Number of participants who experience one or more medically-attended adverse events (AEs);Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of moderate to severe COVID-19;Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Number of participants who experience one or more treatment-related adverse events of special interest (AESI);Number of participants who experience a fatal serious adverse event (SAE);Intensity grading of adverse events of special interest (AESI) per FDA toxicity grading scale