European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
No Result
View All Result
Home < INDUSTRIES Health

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

by Alex Weber
July 20, 2022
A A
Share on LinkedinShare on Twitter

NEW YORK and MAINZ, GERMANY, July 19, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they 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) to work towards introducing an Omicron-adapted bivalent vaccine candidate to address the continued evolution of SARS-CoV-2.

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine. The bivalent vaccine candidate was well-tolerated with a favorable safety profile.

Pfizer and BioNTech previously shared these data with the U.S. Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

  • A 3-dose primary series to individuals 6 months through 4 years of age
  • a 2-dose primary series to individuals 5 years through 11 years of age
  • a 2-dose primary series to individuals 12 years of age and older
  • a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise

Booster Series

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
  • a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

COMIRNATY® INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

HOW IS COMIRNATY ® GIVEN?
COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart.

COMIRNATY® AUTHORIZED USES
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

  • a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise

Booster Dose

  • a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

Emergency Use Authorization
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITY
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably.

Tags: < New Launches

Related Industries

Health

Interview with Mr. Sébastien Huron, CEO, Virbac group

March 6, 2023
Health

Bayer driving innovation in radiology with new research across the portfolio presented at ECR

February 23, 2023
Health

Philips recognized as top innovator for 10th consecutive year

February 17, 2023
Health

Bayer completes acquisition of Blackford Analysis Ltd.

February 14, 2023
Health

Sandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolio

January 25, 2023
Health

Aleksandra Rizo Appointed as CEO of Vividion Therapeutics

January 25, 2023

Interview with Vincent Graziani, CEO, IDEX Biometrics

March 2, 2023

...

Volkswagen Appoints Nicole Mommsen as Head of Global Communications and Sustainability at Group Technology

March 1, 2023

...

Alstom’s Virtual Universe: bringing rail innovation to life in a digital world

March 24, 2023

...

Leasys and Free2move Lease Consolidation: New Top Leadership Announced

March 3, 2023

...

ELC Partners with boom! to Empower Women in Supply Chain in the UK and Worldwide

March 7, 2023

...

Amazon named as a “Top Employer 2023” in Europe

March 1, 2023

...

Dorothea von Boxberg to be CEO of Brussels Airlines

March 24, 2023

...

L’ORÉAL INVESTS IN BIOTECHNOLOGY VENTURE TO SCALE DEVELOPMENT OF PLANT-BASED INGREDIENTS FOR SUSTAINABLE BEAUTY

March 22, 2023

...

Two Wins for Continental at this Year’s Tire Technology International Awards for Innovation and Excellence

March 23, 2023

...

GE Renewable Energy continues to add wind power to Lithuania

March 3, 2023

...

Asia Pacific Business Asia Pacific Business Asia Pacific Business

EUROPEAN BUSINESS is a premier source of corporate news, business information and insights across broad spectrum of industries in Europe and worldwide.  We are one of the members of the Business World Network.

RESOURCES

  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

CONTACT US

EDITORIAL:     editor # european-biz.com

PARTNERSHIP:     partnership # european-biz.com

HUMAN RESOURCE:     hr # european-biz.com

* (replace # with @)

  • Official Site

Copyright © EUROPEAN-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © EUROPEAN-BIZ.COM All rights reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist