FDA Orders J&J Vaccines Made At Baltimore Emergent Plant To Be Tossed
BALTIMORE (WJZ) -- The Food and Drug Administration is forcing Johnson & Johnson to throw out millions of vaccine doses made at a plant here in Baltimore.
The FDA, for months, had been reviewing and testing the doses manufactured at the Emergent Biosolutions facility here in Baltimore.
The FDA said "several batches" of the J&J vaccine made here in Baltimore need to be tossed. The New York Times is reporting that number totals 60 million doses.
"It's obviously very tragic that now an additional 60 million doses will have to be discarded because of the problems at this plant at a time there's a huge global shortage of vaccines," said Dr. Bill Moss, professor at Johns Hopkins University Bloomberg School of Public Health and executive director of the International Vaccine Access Center.
The Emergent plant has been closed for two months.
An FDA report released in April showed a number of issues at the plant, including "the design of the building," "improper medical waste handling," "peeling paint," "black and brown residue on the floors and walls" and "poorly trained staff."
"We have to scale up manufacturing, but that needs to be done very carefully," Moss said.
A source tells WJZ 10 million doses were authorized.
The FDA approved two batches of the vaccine after a review of facility records and quality testing.
Tinglong Dai, an associate professor at the Johns Hopkins Carey Business School and on the leadership team at the Hopkins Business of Health Initiative, said the move is necessary.
"By taking such action, the FDA is really helping restore the public trust," he said.
The company's CEO told Congress last month quality control measures worked.
"The production lot was quarantined, set aside and never left our facility," said Robert Kramer, Emergent CEO.
In a statement to WJZ, an Emergent spokesperson said, in part, they "look forward to continuing to work with the the FDA and Johnson & Johnson toward release of additional doses and resuming production at our Bayview facility.
Regulators, however, say they're "not ready" to authorize manufacturing again at the East Baltimore Plant.
The FDA said those approved batches, totaling about 10 million doses can be used here and other countries.
