Pfizer Inc.

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Pfizer And Biontech Initiate Rolling Submission Of Supplemental Biologics License Application To U.S. FDA For Booster Dose Of Comirnaty® In Individuals 16 And Older

Published: 08/25/2021 16:36 GMT
Pfizer Inc. (PFE) - Pfizer and Biontech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty® in Individuals 16 and Older.
Pfizer - New Phase 3 Data Show Booster Dose of Comirnaty Induces Significant Sars-cov-2 Neutralizing Antibody Titers and Shows Favorable Safety, Tolerability Profile.
Pfizer Inc - Sars-cov-2 Neutralizing Titers Against Wild-type Strain One Month After Booster Dose Were 3.3 Times Titers One Month After Second Dose.
Pfizer Inc - Post-dose-three Neutralizing Titers Met Prespecified 1.5-fold Non-inferiority Criterion for Success and Were Statistically Superior.
Pfizer Inc - Adverse Event Profile Was Generally Consistent With Other Clinical Data for Comirnaty.
Pfizer Inc - Titers After Dose Three Met Pre-specified 10% Non-inferiority Margin for Difference in Four-fold Seroresponse Rates.
Pfizer - Co & Biontech Intend to File Phase 3 Data of Comirnaty With Ema and Other Regulatory Authorities Around World in Coming Weeks.
Pfizer Inc - Intend to Complete Submission of Sbla for Booster Dose of Comirnaty by End of This Week.
Pfizer Inc - Reactogenicity Profile Within Seven Days After Booster (third) Dose Was Typically Mild to Moderate.