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Tozinameran - BioNTech/Pfizer

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Drug Profile

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/Pfizer

Latest Information Update: 26 Aug 2024

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • 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

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