ATLANTA -- The Centers for Disease Control and Prevention has "heightened concern" that the nation will not receive all the seasonal influenza shots it needs this fall, in the aftermath of the Food and Drug Administration's stern warning over contamination issues against Sanofi Pasteur, the country's largest flu vaccine maker.
Sanofi, which is producing 50 million doses of injectable influenza vaccine at its Swiftwater, Pa., manufacturing plant, was slapped by the FDA last week for what the regulatory agency called "a number of significant objectionable conditions" at the plant.
Among them were findings that 11 lots of Fluzone concentrate used to make the seasonal flu doses were contaminated with an unnamed microbe, out of 250 to 300 lots needed to make the promised vaccine.
"We are concerned," said Dr. Lance Rodewald, director of the CDC's immunization services division. "We are always concerned. Now, concern is heightened."
Since problems have hit the nation's seasonal flu vaccine program in four of the last six years, Rodewald said the CDC is watching Sanofi "very closely," not just because the firm is America's largest producer, but because it also produces vaccine for children under age 4, one of the groups at highest risk for seasonal influenza.
The FDA would not identify the contaminant, but agreed with Sanofi that the problem appeared unlikely to prevent Sanofi Pasteur from making its 50 million doses.
That amount is about 40 percent of the 120 million total flu shots expected for the United States this year.