• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Newsmakers: Darren Shirley

    Are You Prepared for the 2023 DSCSA Deadline?

    Rethinking the Changing Role of the CRO

    23rd Annual Salary Survey

    Pharma 4.0 and the Modernizing Power of Digital Technology Transfer
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate

    Pfizer, BioNTech Adapt COVID Vax Against Omicron

    CoreRx Expands Capabilities

    Pierre Fabre and Lonza Enter Manufacturing Agreement

    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    CoreRx Expands Capabilities

    Pierre Fabre and Lonza Enter Manufacturing Agreement

    Qosina Strengthens Aseptic Capabilities

    MilliporeSigma Opens $65M CDMO Facility for Cancer Therapies

    Antheia Receives $40 million in Venture Debt Financing
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Tubular Glass Primary Packaging for Pharmaceutical, Biotech and Diagnostic Containment

    How to Improve the Cold Chain System in Remote Locations

    Sentry Biopharma Services: Protecting Pharmaceutical Integrity

    Yourway to Build New Flagship European Depot

    Newsmakers: Darren Shirley
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate

    MasterControl and Elemental Machines Form Biomanufacturing Partnership

    Charles River and Ziphius Vaccines to Manufacture saRNA-based Vaccine

    Cullinan Oncology, Taiho to Develop & Commercialize CLN-081/TAS6417 in the U.S.

    BioNTech Breaks Ground on First mRNA Vax Mfg. Facility in Africa
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Should Remote Pharma GMP Audits End After COVID?

    Why is Big Pharma Increasingly Adopting 505(b)(2)?

    Sentry Biopharma Services: Protecting Pharmaceutical Integrity

    Selkirk Pharma Appoints New Head of Quality

    Be Safer by Doing Less: The Future of Zero Touch AE Case Processing
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Aphena Pharma Solutions

    Societal CDMO

    Quotient Sciences

    IDT Biologika
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Baxter BioPharma Solutions

    Aphena Pharma Solutions

    Societal CDMO

    Quotient Sciences

    IDT Biologika
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY

    Grants first full approval for COVID vaccine.

    FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY
    The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 vaccine).
    Related CONTENT
    • CPhI North America Travel
    • Sekisui
    • pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    • Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany
    • Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate
    08.23.21
    Pfizer and BioNTech announced that the U.S. FDA approved the Biologics License Application (BLA) for COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.
     
    The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 vaccine). The EUA permitted essential rollout of vaccine doses across the U.S. to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.
     
    For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.
     
    “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, chairman and CEO, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the United States since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”
     
    Ugur Sahin, CEO and co-founder, BioNTech, said, “Today's full approval by the FDA underlines the vaccine's high efficacy and favorable safety profile. Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”
     
    As announced on August 16, Pfizer and BioNTech plan to seek licensure of a third, or booster, dose of COMIRNATY in individuals 16 years of age and older via a supplemental BLA. The companies also intend to submit a supplemental BLA to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data out to six months after the second vaccine dose are available. In the meantime, the vaccine remains available to 12- to 15-year-olds under the EUA granted by the FDA on May 10, 2021.
    Related Searches
    • Biologics, Proteins, Vaccines
    Suggested For You
    CPhI North America Travel CPhI North America Travel
    Sekisui Sekisui
    pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany
    Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate  Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate
    Clean Cells Expands Bioproduction Capabilities Clean Cells Expands Bioproduction Capabilities
    CEO Spotlight: Gaston Salinas, Botanical Solution Inc. CEO Spotlight: Gaston Salinas, Botanical Solution Inc.
    Lakes BioScience Signs Agreement with Cytvia Lakes BioScience Signs Agreement with Cytvia
    Boyds Opens US Office in PA Boyds Opens US Office in PA
    COVID Booster Vaccines: What’s Next for FDA COVID Booster Vaccines: What’s Next for FDA
    GeneQuine, Exothera Enter Gene Therapy Partnership GeneQuine, Exothera Enter Gene Therapy Partnership
    Repligen and Navigo Launch Antibody Technology Platform Repligen and Navigo Launch Antibody Technology Platform
    Boehringer Ingelheim, Twist Bioscience Enter Antibody Discovery Collaboration Boehringer Ingelheim, Twist Bioscience Enter Antibody Discovery Collaboration
    GeneQuine Contracts Exothera to Support the Development of Its Osteoarthritis Gene Therapy GeneQuine Contracts Exothera to Support the Development of Its Osteoarthritis Gene Therapy
    Gaston Salinas Botanical Solution Inc. Gaston Salinas Botanical Solution Inc.

    Related Content

    • CPhI North America Travel

      CPhI North America Travel

      ...
      04.21.22

    • Sekisui

      ...
      Jim Alferman, Associate Director, Business Development 10.13.21

    • Breaking News | Clinical Trials
      pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

      pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

      According to the study, the novel prophylactic nasal spray prevented infection from SARS-CoV-2, the virus that causes COVID-19.
      09.22.21


    • Biologics, Proteins, Vaccines | Breaking News | Clinical Trials
      Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany

      Immunic Inc. Signs In-License Agreement with University Medical Center Goettingen, Germany

      Covers the combination of DHODH inhibitors and nucleoside analogues to treat viral infections, including Covid-19.
      09.22.21

    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
      Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate

      Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate

      Will initiate the GMP manufacturing of the clinical batches of FluGen’s M2SR influenza vaccine candidate for upcoming clinical trials.
      09.21.21

      Loading, Please Wait..
      Trending
      • Pierre Fabre And Lonza Enter Manufacturing Agreement
      • 17th Annual Contracting & Outsourcing Conference Photos
      • Machine Learning-based Predictive Modeling: Notable Uses In Clinical Trials
      • LabVantage Solutions Adds Mixed Reality Technology to Its Advanced LIMS Platform
      • MilliporeSigma Opens $65M CDMO Facility For Cancer Therapies
      Breaking News
      • Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
      • Pfizer, BioNTech Adapt COVID Vax Against Omicron
      • CoreRx Expands Capabilities
      • Qosina Strengthens Aseptic Capabilities
      • Charles River and Ziphius Vaccines to Manufacture saRNA-based Vaccine
      View Breaking News >
      CURRENT ISSUE

      June 2022

      • Newsmakers: Darren Shirley
      • Are You Prepared for the 2023 DSCSA Deadline?
      • Rethinking the Changing Role of the CRO
      • 23rd Annual Salary Survey
      • Pharma 4.0 and the Modernizing Power of Digital Technology Transfer
      • CEO Spotlight: David Chang
      • Changes are on the Horizon for Single-use Systems in Pharmaceutical Manufacturing
      • CRO Industry Market Report

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Japanese Mushroom Extract Appears Helpful in HPV Infections
      Fi & Hi Europe Returns with Over 20,000 Global Attendees Expected
      United Plant Savers Launches First Film Festival
      Coatings World

      Latest Breaking News From Coatings World

      American Colors to Expand Sandusky, Ohio Facility
      Vaughn O’Dea Named Director of Epoxytec
      Dr. Tammo Boinowitz to Join ALTANA's Management Board
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Accelmed Partners II, Lauxera Capital Partners Invest in Veranex
      Agnes Lee Named SVP of Investor Relations, Strategic Planning at Inogen
      Dr. Brandee Pappalardo Joins Fresenius Kabi as Chief Medical Officer
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate
      Pfizer, BioNTech Adapt COVID Vax Against Omicron
      CoreRx Expands Capabilities
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Top 5 Beauty Tech Trends at Perfect Corp.'s Global Forum
      John Frieda Supports the LGBTQIA+ Community
      Athena Club Launches in Canada
      Happi

      Latest Breaking News From Happi

      Color Street Celebrates Foster, Adoption Awareness with Limited-Edition Print
      CIR Panel Conducts 161st Meeting Regarding Safety Assessments for Cosmetic Ingredients
      DIY Nail Care Is Outperforming the Professional Segment: Kline
      Ink World

      Latest Breaking News From Ink World

      Dr. Tammo Boinowitz to Join Management Board of ALTANA AG
      Flint Offset Packaging Solutions Announces Price Increases for Sheetfed Inks
      Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Harveer Sahni recognized with Global Achievement Award
      Color-Logic partners with Taktiful 
      ALTANA announces Management Board change
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Fibertex Personal Care Awarded EcoVadis Awards for Sustainability
      Yanpai Orders Batt Forming Equipment for Needlepunch Line
      Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Researchers Discover Novel Patching Material for Bone Defects
      Boston Centerless Opens Second Manufacturing Plant in Indiana
      Researchers Develop Patient-Specific 3D-Printed Smart Metamaterial Implants
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Identiv-Powered CVS Spoken Rx Wins NFC Forum 2022 Innovation Award
      LG Display Announces Winners of This Year’s OLEDs GO! Competition
      Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login