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A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

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Trial Profile

A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 14 Sep 2023

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At a glance

  • Drugs Abdavomeran (Primary) ; Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors BioNTech

    • Most Recent Events

    • 11 Sep 2023 According to a Pfizer media release, this decision follows guidance from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), which recommended an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season.
    • 11 Sep 2023 According to a Pfizer media release, the USA Food and Drug Administration (FDA) approved the supplemental Biologics License Application (COMIRNATY 2023-2024 Formulation) for individuals 12 years and older and granted emergency use authorization for individuals 6 months through 11 years of age for the companies Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.
    • 27 Feb 2023 According to a Pfizer media release, company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as a primary series and booster dose(s) for individuals 12 years of age and older.
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