• 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
    Phastar Appoints Chris Schoonmaker as Chief Operations Officer

    Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK

    EQT Private Equity Acquires SPT Labtech from Battery Ventures

    Shimadzu Scientific Instruments Extends HQ Campus

    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
    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

    Shimadzu Scientific Instruments Extends HQ Campus

    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills

    Batavia Enters Commercial Manufacturing Business

    CoreRx Expands Capabilities

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    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

    Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK

    EQT Private Equity Acquires SPT Labtech from Battery Ventures

    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
    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
    Kyongbo Pharmaceutical

    Biosynth Carbosynth

    Qosina

    Societal CDMO

    CMC Pharmaceuticals
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Kyongbo Pharmaceutical

    Biosynth Carbosynth

    Qosina

    Societal CDMO

    CMC Pharmaceuticals
    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 Issues Guidance on EUA for COVID-19 Vaccines

    Provides further information on the EUA process for investigational vaccines.

    FDA Issues Guidance on EUA for COVID-19 Vaccines
    The recommendations in the guidance describe key information and data that would support issuance of an EUA.
    Related CONTENT
    • Sekisui
    • pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    • Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients
    • J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax
    • Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate
    Contract Pharma Staff10.07.20
    On October 6, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.
     
    The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
     
    This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency's June guidance regarding the development and licensure of COVID-19 vaccines.
     
    An EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine's safety and effectiveness.
     
    This guidance also reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.
     
    Assuring Quality, Safety and Efficacy
     
    "Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” commented Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. “The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.”
     
    “In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved,” Marks added.
     
    The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines.
    Related Searches
    • Biologics, Proteins, Vaccines
    Suggested For You
    Sekisui Sekisui
    pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray
    Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients  Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients
    J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax
    Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate  Naobios to Manufacture FluGen’s M2SR Flu Vax Candidate
    CuriRx Launches CuriLytics Platform for Biotherapeutic Development CuriRx Launches CuriLytics Platform for Biotherapeutic Development
    Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention Lilly’s Antibody Treatment Gets EUA for Post-Exposure COVID Prevention
    BioVaxys Reports Progress on Covid-19 Vax Candidate BioVaxys Reports Progress on Covid-19 Vax Candidate
    Vaccine Developer Intravacc Adopts Hybrid Business Model Vaccine Developer Intravacc Adopts Hybrid Business Model
    Clean Cells Expands Bioproduction Capabilities Clean Cells Expands Bioproduction Capabilities
    Symbiosis Completes Successful MHRA Audit Symbiosis Completes Successful MHRA Audit
    Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals Catalent Signs Commercial Supply Agreement with Phathom Pharmaceuticals
    U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail U.S. Govt. to Purchase Additional Doses of REGEN-COV Antibody Cocktail
    U.S. Govt. Purchases Additional Doses of Lilly U.S. Govt. Purchases Additional Doses of Lilly's Antibody Therapies for COVID
    CEO Spotlight: Gaston Salinas, Botanical Solution Inc. CEO Spotlight: Gaston Salinas, Botanical Solution Inc.

    Related Content

    • 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

    • Breaking News | Drug Development | Industry News
      Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients

      Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients

      Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization.
      09.22.21


    • Biologics, Proteins, Vaccines | Breaking News | Industry News
      J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax

      J&J Data Confirms Strong and Long-Lasting Protection of COVID-19 Vax

      Phase 3 ENSEMBLE trial shows booster shot at two months provided 94 percent protection against COVID-19 in the U.S.
      09.21.21

    • 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
      • Regulatory Report: Analytical Procedure Development
      • Pierre Fabre And Lonza Enter Manufacturing Agreement
      • Pfizer, BioNTech Adapt COVID Vax Against Omicron
      • Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
      • Shimadzu Scientific Instruments Extends HQ Campus
      Breaking News
      • Phastar Appoints Chris Schoonmaker as Chief Operations Officer
      • Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK
      • EQT Private Equity Acquires SPT Labtech from Battery Ventures
      • Shimadzu Scientific Instruments Extends HQ Campus
      • Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
      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

      Kensing Acquires Vitae Naturals
      CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
      Shiitake Mushroom Extract Appears Helpful in HPV Infections
      Coatings World

      Latest Breaking News From Coatings World

      Sheboygan Paint Company Adds Rosey Malchow as Customer Experience Manager
      PPG to Announce Second Quarter 2022 Results July 21
      Evonik Unveils Range of Sustainable Liquid Polybutadienes
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Researchers Develop New Apparatus for the Treatment of Cardiovascular Diseases
      NovaXS Unveils New Prototype of Needle-Free Injection Therapy Smart Medical Device
      Meddux Opens New Facility in Boulder, Colorado
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Phastar Appoints Chris Schoonmaker as Chief Operations Officer
      Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK
      EQT Private Equity Acquires SPT Labtech from Battery Ventures
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Highlights from Paris Packaging Week
      Walgreens Boots Alliance Decides Not to Sell Boots and No7 Beauty Company Businesses
      WWP Beauty Unveils New Packaging Collections in Collaboration with Eastman
      Happi

      Latest Breaking News From Happi

      Evonik Holds Groundbreaking Ceremony for Commercial Rhamnolipid Production Facility
      CHT USA Hosts Groundbreaking Ceremony for $20 Million US Headquarters Expansion
      Azelis Expands Global Flavors & Fragrances Platform with Acquisition in India
      Ink World

      Latest Breaking News From Ink World

      Temporary Content Title
      Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
      Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Sibress launches FADS3D flexo plate measuring device
      Mike Brown appointed VP for Davis-Standard’s Canadian operations
      Constantia Flexibles introduces chemical resistant recycle-ready laminate
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Suominen Launches Hydraspun Reserve
      Richard Knowlson Receives Lifetime Technical Achievement Award
      Skylark Launches Thicker Label Closure Technology in North American
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tecomet Appoints Bill Dow as President & CEO
      Medacta, InSilicoTrials Partner on Orthopedic Device Development
      Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Avery Dennison Launches New Dual-Frequency RFID Inlay
      Avery Dennison Highlights New Approach to Apparel with ADX Lab
      trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments

      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