UPDATE: FDA Wyeth Recalls One Lot Of Prevnar Vaccine
July 16 2009 - 8:06PM
Dow Jones News
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;
jennifer.corbett@dowjones.com