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Staffers at a Baltimore manufacturing plant — where 15 million doses of Johnson & Johnson’s COVID-19 vaccine were botched — didn’t shower or change clothes before entering the manufacturing area, according to a report released Wednesday.
In a three week period between January and February, there were more than three dozen instances of personnel at Emergent BioSolutions entering the manufacturing area without documentation of a shower — violating protocol, according to an FDA report released by a Congressional House committee.
In one instance, an associate only documented one shower in 19 days of work, the report said.
Inspectors also found problems with mold and unsatisfactory sanitation of plant equipment — and documented workers mishandling medical waste.
“The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and disperse, and engineering operations to prevent cross contamination of bulk drug substances created for client [redacted] and client [redacted],” government investigators concluded.
The Select Subcommittee on the Coronavirus Crisis held a hearing Wednesday to examine the plant’s role in the ruined J&J shots.
Emergent BioSolutions was awarded $650 million to manufacture vaccines being developed by medical companies, Rep. James Clyburn said.
“But nearly a year later, Emergent has destroyed millions of vaccines due to contaminations, and millions more are being held back for testing to ensure they can be used,” the South Carolina Democrat said.
“All due to Emergent’s failure to properly maintain its facilities, adequately train its staff and ensure the proper protocols were followed.”
Authorities had said the expensive vaccine mishap was due to human error, and cross contamination of vaccine ingredients
Lawmakers Wednesday clarified that the J&J vaccine itself was not on trial. The Baltimore plant is not FDA-authorized to manufacture or distribute J&J’s vaccine in the US, and doses that have been rolled out here are shipped in from Europe.
Robert Kramer, the company’s CEO, who made $5.6 million in salary and incentives last year, sold a $10 million chunk of stock in the company in the months before the vaccines were ruined and the company’s assets plummeted.
Shareholders sued Emergent BioSolutions, saying the stock price was inflated due to the company’s suppression of problems at the plant.
“Emergent’s top priority continues to be the strengthening of the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine,” Kramer said last month. “We have been working closely with Johnson & Johnson and welcome the additional oversight and support at our Bayview facility.”
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