May 6, 2009 (CIDRAP News) –The US Food and Drug Administration (FDA) today announced approval of a new influenza vaccine manufacturing facility in Pennsylvania that could be used to produce a vaccine against the novel influenza H1N1 (swine flu) virus.
The Sweetwater, Pa., facility is owned and operated by Sanofi Pasteur, which is already the nation's largest seasonal flu vaccine producer and manufactures the only prepandemic H5N1 avian influenza vaccine for the nation's Strategic National Stockpile.
Jesse Goodman, MD, MPH, the FDA's acting chief scientist and deputy commissioner for scientific and medical programs, said in a press release today that increased capacity for influenza vaccines is critical for pandemic preparedness as well as seasonal influenza. "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 5 years," he said.
Sanofi will use the new facility to make Fluzone, the company's egg-based influenza vaccine. It completed construction of the new $150 million, 140,000-square-foot plant injury 2007 and said it had hoped to bring the facility online by late 2008 or early 2009, according to a company press release in 2007.
In 2007 the US Department of Health and Human Services (HHS) awarded Sanofi a $77.4 million grant to retrofit existing vaccine production facilities and keep them ready for 2 years to produce pandemic flu vaccines, with an option to extend the time to 5 years, according to previous reports. Sanofi had said it hoped to complete the retrofitting by late 2010. The company contributed $25 million toward there novation of its existing plant.
Construction of Sanofi's new facility was designed to add capacity for 100 million doses of seasonal flu vaccine each year, while the renovation was expected to add production capacity of about 50 million doses each year.
When the HHS awarded the contract to Sanofi, it also awarded a similar retrofitting contract for $55.1million to MedImmune, Inc. The department's goal in boosting capacity at the two plants was to allow them to produce 100 million doses of a pandemic vaccine within 6 months of the start of a pandemic.
Officials from the Centers for Disease Control and Prevention (CDC) have said that they are working on a seed strain for a vaccine against the novel H1N1 influenza virus. If pilot trials and production go smoothly, the nation could have a vaccine against the new influenza strain this fall. However, they also said that the decision about whether to use the vaccine would be made separately.
May 6 FDA news release
Jun 20, 2007, CIDRAP News story "Flu vaccine makers get HHS funds to prepare for pandemic"
Jul 20, 2007, Sanofi press release