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CHMP positive opinion for Omicron KP.2-adapted COVID-19 vaccine in the EU – Pfizer + BioNTech

Written by | 7 Oct 2024

Pfizer  and BioNTech SE announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended marketing authorization for the companies’… read more.

FDA approval & authorization for Omicron KP.2-adapted COVID-19 Vaccine – BioNTech SE + Pfizer

Written by | 30 Aug 2024

Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY (COVID-19 Vaccine, mRNA),… read more.

Pfizer and BioNTech receive first USA emergency use authorization of a COVID 19 vaccine for children ages 5-11

Written by | 3 Nov 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred… read more.

Pfizer and BioNTech receive first FDA Emergency Use Authorization of a COVID-19 vaccine booster

Written by | 20 Oct 2021

Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.

Pfizer and BioNTech announce submission of initial data to FDA to support booster dose of COVID-19 Vaccine

Written by | 31 Aug 2021

Pfizer Inc. and BioNTech SE announced that they have submitted Phase 1 data to the FDA to support the evaluation of a third, or booster, dose of the… read more.

FDA expands approval of Comirnaty for young people with COVID-19 – Pfizer and BioNTech

Written by | 18 May 2021

Pfizer and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) for their Comirnaty COVID-19 vaccine to include individuals 12 to 15 years of… read more.

Real world evidence from Israeli Ministry of Health analysis confirms high effectiveness of the Pfizer-BioNTech COVID 19 vaccine

Written by | 24 Mar 2021

The Israel Ministry of Health (MoH), Pfizer Inc. and BioNTech SE announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the… read more.

Pfizer and BioNTech SE initiate a study as part of broad development plan to evaluate COVID 19 booster and new vaccine variants

Written by | 1 Mar 2021

Pfizer Inc.and BioNTech SE announced they have begun an evaluation of the safety and immunogenicity of a third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the… read more.

Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to the FDA

Written by | 23 Feb 2021

Pfizer Inc. and BioNTech SE announced the submission of new data to the FDA demonstrating the stability of their COVID-19 vaccine when stored at -25°C to -15°C (-13°F… read more.

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