Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT162b2s01 · 1 trial · 2 indications
For treatment-emergent SAEs and AESIs (TESAEs, TEAESIs), the data refers to the interval "Dose 1 up to 28 days after Dose 1". For other SAEs and AESIs, the data refers to the interval "Dose 1 up to 26 weeks after Dose 1". A TESAE/TEAESI is defined as any SAE/AESI with an onset after the first IMP dose or worsened after the first IMP dose (if the SAE/AESI was present before the first administration of IMP). SAEs/AESIs with an onset date more than 28 days after the last administration of IMP will be considered as TESAE/TEAESI only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are also included in the respective Group B arms and therefore counted in more than one arm/group. Overall a total of 137 participants were enrolled into this study (including the Group B immunology subset participants).
Local reactions (pain, tenderness, erythema/redness, induration/swelling) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
Systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) were graded using criteria based on the guidance given in US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials"; the guidance uses the Grades 1 (mild), 2 (moderate), 3 (severe), and 4 (potentially life-threatening). The reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
A TEAE is defined as any AE with an onset after the first IMP injection or worsened after the first IMP injection (if the AE was present before the first administration of IMP). AEs with an onset date more than 28 days after the last administration of IMP will be considered as treatment-emergent only if assessed as related to IMP by the investigator. Participants of the Group B immunology subset are part of the Group B. The 'Total' arms include all participants from the respective Group A and Group B immunology subset arms presented.
| Arm | Type | Description |
|---|---|---|
| Group A, BNT162b2s01 30 μg (1 dose) | EXPERIMENTAL | Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) in the parent trial received one booster injection of BNT162b2s01 on Day 1. Day 1 (baseline in this trial) must have occurred ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial. |
| Group A, BNT162b2 30 μg (1 dose) | EXPERIMENTAL | Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) in the parent trial received one booster injection of BNT162b2 (Comirnaty) on Day 1. Day 1 (baseline in this trial) must have occurred ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial. |
| Group B, BNT162b2 30 μg (2 doses) | EXPERIMENTAL | Trial participants in either the trial BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) in the respective parent trial were offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. Day 1 (baseline in this trial) must have occurred ≥12 weeks after receiving the last BNT162 candidate vaccine in the respective parent BNT162-01 or BNT162-04 trial. |
| Group B transplant subjects, BNT162b2 30 μg (2 doses) | EXPERIMENTAL | Transplant trial participants from Cohort 13 of the trial BNT162-01 received one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which was followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). Day 1 (baseline in this trial) must have occurred ≥12 weeks after receiving the last BNT162 candidate vaccine in the parent BNT162-01 trial. |
| Name | Type | Description |
|---|---|---|
| BNT162b2s01 | BIOLOGICAL | intramuscular (IM) injection |
| BNT162b2 | BIOLOGICAL | IM injection |
Inclusion Criteria: * Had given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. * Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the Ger...
BNT162b2s01 is an investigational monoclonal antibody being studied for COVID-19 and SARS-CoV-2 infection. It is being evaluated as a potential additional dose option in individuals who previously participated in BNT162-01 or BNT162-04 trials. The drug is currently in Phase 2 clinical development and is not yet approved.
BNT162b2s01 is a monoclonal antibody designed to target SARS-CoV-2, the virus that causes COVID-19. As an antibody, it is intended to neutralize the virus, though specific molecular targets have not been disclosed. The drug is being investigated for its safety and effects in a clinical trial setting.
BNT162b2s01 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. BioNTech is conducting clinical research on this monoclonal antibody for COVID-19, with the drug currently in Phase 2 development.
BNT162b2s01 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for COVID-19 and SARS-CoV-2 infection, with one completed Phase 2 trial involving 137 participants.
BNT162b2s01 has been studied in one clinical trial, NCT04949490, which is a Phase 2 study titled 'A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects'. The trial was conducted in Germany and has been completed.
BNT162b2s01 is not the same as Comirnaty. Comirnaty is a COVID-19 vaccine, while BNT162b2s01 is a monoclonal antibody. The clinical trial NCT04949490 compared the effects of additional doses of Comirnaty with one dose of BNT162b2s01, indicating they are distinct investigational products.