UPDATE: FDA Wyeth Recalls One Lot Of Prevnar Vaccine >WYE
(Updates with quote from Wyeth spokeswoman)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Wyeth (WYE) is recalling one lot of its pediatric Prevnar vaccine after the company discovered a portion of the lot contained material not intended for commercial use.
In a recall notice posted on FDA's Web site Thursday, Wyeth said it "concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate."
Lili Gordon, a Wyeth spokeswoman, said the recall affects 96,280 doses although the company believes that most of the doses have already been used. The doses, which were lot number D50002, were shipped in January and February of this year. The vaccine is given in a four-dose series.
She said the company, "determined that 16,000 doses of one lot of pre-filled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product." The material used in all of the syringes, however, was of the same quality.
Although the company believes most of the recalled lot has already been used, doctors who have remaining vaccine can return it.
Prevnar, given to infants and toddlers, is designed to protect against seven types of streptococcus pneumoniae, strains of bacteria that cause a range of illnesses like ear infections, pneumonia, bloodstream infections and meningitis, an infection of the covering of the brain and spinal cord. The vaccine had $2.7 billion in sales last year. Wyeth is currently awaiting FDA approval of a new version of the vaccine designed to protect against 13 types of bacteria.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; firstname.lastname@example.org