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.

Product Showcase

  • SwabTek® Cannabis Test Kit

    The SwabTek® Cannabis Test Kit is a single-use spot test designed for use in screening for cannabis compounds in any sample type or on any surface. The test is capable of identifying the presumed presence of cannabinoids in very small quantities, with a level of detection as little as 6 μg in mass. Learn more about the SwabTek® Cannabis Test Kit and the rest of SwabTek surface drug testing solutions through the webinar titled "Everything You Want To Know About Surface Testing" 3

  • NoiseCHEK Personal Noise Dosimeter

    SKC NoiseCHEK is the easiest-to-use dosimeter available! Designed specifically for OEHS professionals, SKC NoiseCHEK offers the easiest operation and accurate noise measurements. Everything you need is right in your palm. Pair Bluetooth models to your mobile devices and monitor workers remotely with the SmartWave dB app without interrupting workflow. Careful design features like a locking windscreen, sturdy clip, large front-lit display, bright status LEDs, and more make NoiseCHEK the top choice in noise dosimeters. Demo NoiseCHEK at AIHA Connect Booth 1003. 3

  • Safety Shower Test Cart

    The Safety Shower Test Cart speeds up and simplifies emergency shower tests, ensures you stay in compliance with OSHA regulations, and significantly reduces testing costs. With 7 unique features, the cart makes testing easy, effective, and efficient. You can test water clarity, flow, temperature, and spread—all at the same time! Most safety shower testing kits create a mess, take too much time to use, and don't fully help you stay in compliance with OSHA & ANSI standards. Transform the way you test emergency showers with Green Gobbler Safety. 3

Featured

Webinars