By Susan Heavey and Lisa Richwine
U.S. regulators approved a new flu vaccine manufacturing plant to boost not only production of seasonal flu shots, but also possible vaccines to protect against the H1N1 swine flu.
The facility, owned by Sanofi-Aventis SA, was cleared to make the company's seasonal Fluzone influenza vaccine in Swiftwater, Pennsylvania, and will eventually more than double the company's yearly flu vaccine production, the Food and Drug Administration said.
It could also be used to produce immunizations against the new H1N1 flu strain if needed, the agency said.
"This is very, very good news for a major important supplier ... it immediately (and) substantially increases their production capacity," Dr. Jesse Goodman, the FDA's acting chief scientist and deputy commissioner for scientific and medical programs, told Reuters.
The company's Sanofi Pasteur unit -- the major supplier for the U.S. market -- already operates another plant in Swiftwater that produces 50 million doses of seasonal flu vaccines a year. The new plant could produce another 50 million doses this year and up to 100 million doses later on, the company has said.
"In total, Sanofi Pasteur will have a capacity of approximately 150 million doses of trivalent seasonal influenza vaccine per year in the U.S. ... from the new facility when it is operating at full capacity," the company said in a statement. It did not say when it would reach full capacity.
Health experts have been concerned for years that the United States lacks enough domestic flu vaccine manufacturing capacity to inoculate the U.S. population. Officials worry countries could reserve the vaccine for their own population in the face of a flu pandemic.
Global health officials are debating whether the threat from the H1N1 virus is serious enough to ask manufacturers to mass-produce a vaccine for it.
It is not clear how many doses of H1N1 vaccine the Sanofi plant could produce with the additional capacity, Goodman said. Experts do not know how quickly the new virus will grow during production or how big a dose will be needed for a vaccine to be effective, he said.
Even with the new facility, Goodman said there is still room for further production increases in the United States.
"We all recognize that there are still unmet needs with seasonal influenza," he added.
Other makers of U.S.-approved seasonal flu vaccines include GlaxoSmithKline, Novartis AG, CSL Ltd's, and AstraZeneca Plc's MedImmune unit. At least some of their flu vaccine is produced outside the United States.