FDA approves new influenza vaccine production facility

The FDA has approved a new manufacturing facility 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 influenza A (H1N1) strain.

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, FDA officials said.

“Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic,” said Jesse Goodman, MD, MPH, 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.”

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.