Drugs / ABDAVOMERAN
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04523571 | Jul → Sep 2020 | COVID-19 | BioNTech SE | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04380701 | Apr 2020 → Jun 2021 | respiratory tract infectious disorder, viral infectious disease | BioNTech SE | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT04368728 | Apr 2020 → Feb 2023 | COVID-19 | BioNTech SE | Completed | Met primary |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-02-01 | BioNTech SE | Results Pfizer and BioNTech Publish Preclinical Data from Investigational COVID-19 Vaccine Program in Nature biontech.com ↗
The preclinical data found immunization of rhesus macaques with either the BNT162b1 or BNT162b2 vaccine candidate elicited SARS-CoV-2 neutralizing geometric mean titers 8.2 to 18.2 times that of a SARS-CoV-2 convalescent human serum panel. |
| 2020-10-14 | BioNTech SE | Results Pfizer and BioNTech Announce New England Journal of Medicine Publication of Phase 1 Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19 biontech.com ↗
The publication describes key safety and immunogenicity data from the Phase 1 portion of the U.S. trial for the BNT162b2 and BNT162b1 vaccine candidates. |
| 2020-09-30 | BioNTech SE | Results BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2 biontech.com ↗
In addition, the initial German trial results demonstrated, for the first time for the BNT62b1 candidate, a concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. |
| 2020-08-12 | BioNTech SE | Results Pfizer and BioNTech Announce Publication of Peer-Reviewed Data from Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate, BNT162b1, Against SARS-CoV-2 in Nature biontech.com ↗
Based on new data, the final, peer-reviewed paper reports that neutralizing titers continued to rise, and, by 14 days after the second dose of 30µg, the participants’ GMT was 4.6-times the convalescent serum panel GMT. |
| 2020-07-20 | Pfizer | Results Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data pfizer.com ↗
BNT162b1 elicited strong CD4 + and CD8 + T cell responses against SARS-CoV-2- receptor binding domain (RBD), compared to baseline |
| 2020-07-14 | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Regulatory Fosun Pharma Announces its Licensed COVID-19 Vaccine Product Receives Acceptance Notice of Clinical Trial Application by NMPA fosunpharma.com ↗
The clinical trial application of the Vaccine was accepted by the National Medical Products Administration (the “NMPA”). |
| 2020-07-13 | Pfizer | Regulatory Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2 pfizer.com ↗ |
| 2020-07-13 | BioNTech SE | Regulatory Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2 biontech.com ↗ |
| 2020-07-01 | Pfizer | Results Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2 pfizer.com ↗ |
| 2020-07-01 | BioNTech SE | Results Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-CoV-2 biontech.com ↗
Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABDAVOMERAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650454 ↗ |
| Known as | BNT162b1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04523571 ↗ |
| Modality | Messenger RNA (mRNA) | “BNT162b1 is a lipid-nanoparticle-formulated, nucleoside-modified mRNA vaccine” PMID 32785213 ↗ Aug 2020 |
| Route | Intramuscular | “Intramuscular injection” NCT04368728 ↗ |