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    Pfizer-BioNTech begin trials of new vaccine against Omicron variant

    Synopsis

    The study will have 1420 subjects, with three cohorts examining different regimens of the current Pfizer-BioNTech COVID vaccine or an Omicron-based vaccine. The first participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose.

    pfizer agencies1Agencies
    The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.
    Pfizer and BioNTech on Tuesday announced the initiation of clinical trials to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age.

    The study will have 1420 subjects, with three cohorts examining different regimens of the current Pfizer-BioNTech COVID vaccine or an Omicron-based vaccine.

    The first participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose.

    The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

    The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

    “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, senior vice president and head of Vaccine Research & Development at Pfizer.

    “Vaccines continue to offer strong protection against severe disease caused by Omicron. Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,” said Ugur Sahin, CEO and co-founder of BioNTech.

    “This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against Omicron as it did with earlier variants but with longer duration of protection,” Sahin added.


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