Employees at a US manufacturing plant which made 15 million unusable doses of Johnson & Johnson’s Covid-19 vaccine, didn’t follow hygiene requirements before entering manufacturing areas, according to a report released on Wednesday.
In a three-week period between January and February, there were nearly 50 instances of personnel at Emergent BioSolutions in Baltimore entering manufacturing areas without documentation of having taken a shower, and so violating protocol, according to a Food and Drug Administration (FDA) report.
One worker only documented a single shower in 19 days of work, the report said.
Inspectors also found problems with mould, unsatisfactory sanitation of plant equipment, and workers mishandling medical waste.
“The firm has failed to adequately train personnel involved in manufacturing operations to prevent cross contamination of bulk drug substances,” government investigators concluded.
The Congress Select Subcommittee on the Coronavirus Crisis held a hearing on Wednesday to examine the plant’s role in the ruined Johnson & Johnson shots, reports the New York Post.
Emergent BioSolutions was awarded US$650 million to manufacture vaccines being developed by medical companies.
“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,” one congressman said. “This was all due to Emergent’s failure to properly maintain its facilities, adequately train its staff and ensure the proper protocols were followed.”
Lawmakers on Wednesday clarified that the Johnson & Johnson vaccine itself was not on trial.
The Baltimore plant is not FDA-authorised to manufacture or distribute Johnson & Johnson’s vaccine in the US. All its doses are for export only.
All Johnson & Johnson doses used in America are shipped in from European manufacturers.
Robert Kramer, the company’s CEO, who made US$5.6 million in salary and incentives last year, sold a US$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.