FDA approves Sanofi Pasteur influenza vaccine production facility
The US Food and Drug Administration (FDA) has approved a new plant for the production of influenza virus vaccines. It has received approval for seasonal influenza vaccine production and could be used for a vaccine against the H1N1 influenza strain.
The US Food and Drug Administration (FDA) has approved a new plant for the production of influenza virus vaccines. It has received approval for seasonal influenza vaccine production and could be used for a vaccine against the H1N1 influenza strain.
The US facility in Swiftwater, PA is owned and operated by Sanofi Pasteur, the manufacturer of fluzone egg-based influenza virus vaccine. The bulk manufacturing 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, the FDA's acting director of the Centre for Biologics Evaluation and Research.
"Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic," added Jesse Goodman, the FDA's acting chief scientist and deputy commissioner for scientific and medical programmes. "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."
The FDA has worked with Sanofi Pasteur throughout the regulatory process to help ensure compliance with requirements.