FDA Approves New Influenza Vaccine Production Facility

The Food and Drug Administration (FDA) has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur's production capability.

"This approval represents an important step towards increasing the availability of influenza vaccines," said Karen Midthun, M.D., the FDA's acting director of the Center for Biologics Evaluation and Research.

"Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic," said Jesse Goodman, M.D., M.P.H., the FDA's acting chief scientist and deputy commissioner for scientific and medical programs. "This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation's preparedness has come a long way over the last five years."

FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements. The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur's egg-based influenza vaccine. Sanofi Pasteur is located in Swiftwater, Pa.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2019

    June 2019

    Featuring:

    • ASSP SAFETY 2019 PREVIEW
      New Orleans Networking
    • NATION SAFETY MONTH
      Heed These Summer Safety Tips
    • TRAINING
      Education, Skill Development, and Behavior Change
    • SAFETY MANAGEMENT
      What Good Looks Like
    View This Issue

Bulwark Quiz