Tozinameran - BioNTech/Pfizer
Alternative Names: BNT 162; BNT 162b2; Bnt-162b2; BNT162b2 vaccine; BNT162b2SA; COMIRNATY; COMIRNATY JN.1; COVID-19 Vaccine, mRNA - BioNTech/Pfizer; Omicron JN.1-adapted monovalent vaccine - BioNTech/Pfizer; Omicron KP.2-adapted monovalent vaccine - BioNTech/Pfizer; PF-07302048; Pfizer-BioNTech COVID-19 vaccine; Pfizer-BioNTech vaccine; SARS-CoV-2 RNA vaccine - BioNTech/PfizerLatest Information Update: 26 Aug 2024
At a glance
- Originator BioNTech; University of Roma La Sapienza
- Developer BioNTech; Pfizer; Pfizer Japan; Shanghai Fosun Pharmaceutical
- Class COVID-19 vaccines; RNA vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed COVID 2019 infections
- Phase II SARS-CoV-2 acute respiratory disease
Most Recent Events
- 22 Aug 2024 US FDA approves sBLA application for Omicron KP.2-adapted mRNA vaccine for COVID-19 infections (Prevention) in USA
- 22 Aug 2024 US FDA grants emergency use authorization for Omicron KP.2-adapted mRNA vaccine for COVID-19 infections (prevention) in USA
- 05 Aug 2024 BioNTech and Pfizer expect US FDA's decision on rolling sBLA for KP.2-adapted monovalent COVID-19 vaccine in USA in September 2024