Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT162a1 · 1 trial · 6 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.
TEAEs without AEs based on solicited reporting via diaries, were analyzed by vaccine, 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.
TEAEs, without AEs based on solicited reporting via diaries, were analyzed by vaccine, 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 |
|---|---|---|
| BNT162a1 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b1 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162c2 (P/B) - Part A 18-55 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162c2 (prime only) - Part A 18-55 years of age | EXPERIMENTAL | Single dose |
| BNT162b1 (P/B) - Part A 56-85 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 56-85 years of age | EXPERIMENTAL | Escalating dose levels |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13) | EXPERIMENTAL | Fixed doses used; cohort 11: alternative posology dose group expansion cohort; cohort 12: adaptive immune response dose group expansion cohort; cohort 13: immunocompromised (IC) participants expansion cohort |
| BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohort 14) | EXPERIMENTAL | fixed doses used; B-cell immune response dose group expansion cohort |
| Name | Type | Description |
|---|---|---|
| BNT162a1 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162b1 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162b2 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
| BNT162c2 | BIOLOGICAL | Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection. |
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...
BNT162a1 is an investigational monoclonal antibody being developed for infectious and respiratory conditions, specifically for protection against COVID-19 and infections with SARS-CoV-2. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BNT162a1 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and effects of this investigational product.
BNT162a1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety and efficacy.
BNT162a1 has been studied in one completed clinical trial, NCT04380701, which investigated the safety and effects of four BNT162 vaccines against COVID-19 in healthy and immunocompromised adults. The trial enrolled 512 participants in Germany and was a controlled study.
BNT162a1 is one of several BNT162 vaccine candidates developed by BioNTech. The clinical trial NCT04380701 investigated four BNT162 vaccines, including BNT162a1, to evaluate their safety and effects against COVID-19. Each candidate may have different characteristics.