Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT162b3 · 1 trial · 2 indications
Solicited local reactions at the injection site (pain, tenderness, erythema/redness, and induration/swelling) were monitored and 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 reporting of local reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) were monitored and 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 reporting of systemic reactions was based on the participant's assessments via daily solicited reports in the participant diaries.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The number and percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
Treatment emergent adverse events (TEAEs) were analyzed by age group, dose level, and for each IMP dose. The percentage of participants reporting at least one TEAE was summarized by adverse event types (any TEAE and any grade \>=3 TEAE) using the Safety Set.
| Arm | Type | Description |
|---|---|---|
| Part A participants aged 18 to 55 years | EXPERIMENTAL | Escalating dose levels |
| Part A participants aged 56 to 85 years (optional) | EXPERIMENTAL | Escalating dose levels |
| Name | Type | Description |
|---|---|---|
| BNT162b3 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen). |
Inclusion Criteria: * Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures. * They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social di...
BNT162b3 is an investigational vaccine being studied for the prevention of Covid-19. It is designed to provide protection against the SARS-CoV-2 virus, which causes Covid-19. The vaccine is currently in Phase 1 clinical development and has not been approved for use.
BNT162b3 is a messenger RNA (mRNA) vaccine that encodes the spike protein of the SARS-CoV-2 virus. The spike protein is the primary target of the immune response, and the vaccine aims to generate neutralizing antibodies against it to prevent Covid-19.
BNT162b3 is being developed by BioNTech SE, a German biotechnology company. BioNTech is publicly traded on the Nasdaq under the ticker symbol BNTX. The company is focused on developing immunotherapies and vaccines, including this Covid-19 vaccine candidate.
BNT162b3 is in Phase 1 clinical development. The Phase 1 trial has been completed, and the vaccine is still investigational. It has not been approved by regulatory authorities, and further clinical studies would be needed to assess its safety and efficacy.
BNT162b3 has been studied in one clinical trial with the identifier NCT04537949. This was a Phase 1 trial conducted in Germany that investigated the safety and effects of the vaccine in healthy adults. The trial enrolled 96 participants and has been completed.
BNT162b3 is one of several vaccine candidates in the BNT162 program developed by BioNTech. It is a distinct candidate with its own formulation and is being evaluated separately. Other candidates in the program may have different characteristics and are not the same as BNT162b3.