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A phase II/III trial to evaluate Omicron adapted vaccine candidates (30 µg and 60 µg) against Omicron BA.1 when compared to the Tozinameran

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Trial Profile

A phase II/III trial to evaluate Omicron adapted vaccine candidates (30 µg and 60 µg) against Omicron BA.1 when compared to the Tozinameran

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 21 Jul 2022

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At a glance

Most Recent Events

  • 19 Jul 2022 According to a Pfizer media release, based on results from this study, the company have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older. This application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA).
  • 01 Jul 2022 New trial record
  • 25 Jun 2022 According to a Pfizer media release, these results are being shared with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in advance of upcoming discussions with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28 and with the International Coalition of Medicines Regulatory Authorities (ICMRA) on June 30.

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