- Some Emergent BioSolutions employees failed to shower at a Baltimore plant, ignoring protocol, an FDA report said.
- Emergent disposed of 15 million Johnson & Johnson vaccine doses from the plant after some had been contaminated.
- "Systemic" failures in sanitation and training "led to the destruction of millions" of doses, a House committee said.
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Some staff failed to shower or change their clothes at the Emergent BioSolutions plant in Baltimore that may have contaminated millions of Johnson & Johnson COVID-19 vaccine doses, according to an FDA report released by a House committee.
These failures to follow protocol, in addition to other "systemic" failures related to sanitation and staff training, "led to the destruction of millions of vaccine doses," the Select Subcommittee on the Coronavirus Crisis said in a memo.
In a five-week period over January and February, 40 staff entered the manufacturing area, and only three showers were documented, the FDA report said. One associate documented one shower in 19 days of work, the report said.
The biopharma company ruined up to 15 million J&J doses earlier this year by cross-contaminating them with ingredients used to make AstraZeneca's vaccine, which is also produced at the facility, the New York Times first reported in March.
The committee, which is investigating Emergent, also said that the company knew about the contamination risks at its plant, but failed to act.
Emergent CEO Robert Kramer told Wednesday's committee hearing that 100 million J&J vaccine doses were on hold for testing by the FDA, which has not yet authorized use of doses of the J&J vaccine produced at the plant.
Emergent signed a $628 million contract with the US government in June last year to expand manufacturing capacity of COVID-19 vaccines. The government asked J&J to take charge of the Baltimore plant following the contamination incident.
The House memo also said that Emergent executives "reaped a windfall as vaccines were destroyed," and that Kramer had received a $1.2 million bonus in 2020 for his "exceptional leadership."
Emergent did not immediately respond to Insider's request for comment.
In April, the FDA inspected the plant and found peeling paint, mold, and inadequate disinfection of factory equipment. The FDA report said that Emergent had "failed to adequately train personnel" manufacturing the vaccine.
Emergent said at the time that it would act quickly to solve the problems at the facility. "While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them," it said in a statement.