Drug Type Prophylactic vaccine, mRNA vaccine |
Synonyms BNT-162b2 Bivalent (WT/OMI BA.4/BA.5), BNT162b2 Bivalent (WT/OMI BA.4/BA.5), ORIGINAL AND OMICRON BA.4/BA.5 + [2] |
Target |
Mechanism SARS-CoV-2 S protein inhibitors(Coronavirus spike glycoprotein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (31 Aug 2022), |
RegulationEmergency Use Authorization (US) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
COVID-19 | US | 31 Aug 2022 | |
COVID-19 | US | 31 Aug 2022 |
Phase 1/2 | - | (uhoqtvrpqa) = Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains hlzeazkjbr (tvbjezwyry ) View more | Positive | 26 Oct 2023 | |||
Phase 2/3 | 74 | (ages 18 to 55 years) | (dedwneolen) = uncqcdebrl ofsgwkekzs (hojjshlouu ) | Positive | 04 Nov 2022 | ||
(55 years and older) | (dedwneolen) = aftuuoyxhd ofsgwkekzs (hojjshlouu ) | ||||||
Phase 2/3 | 40 | carvtuukhl(szmynciyvv) = Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels cuigqjlrzw (ckcsqiolsk ) View more | Positive | 13 Oct 2022 |