House Panel Details Baltimore Vaccine Plant Problems

Ralph Ellis

May 20, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Emergent BioSolutions was warned repeatedly of problems at the Baltimore factory where 15 million doses of the Johnson & Johnson COVID-19 vaccine were contaminated, documents released Wednesday by the House Select Subcommittee on the Coronavirus Crisis showed.

"These warnings came in internal inspections as well as inspections and audits by FDA, Johnson & Johnson, and AstraZeneca," the report said. "The inspections found that Emergent's Bayview facility had persistent problems with mold, poor disinfection of plant equipment, and inadequate training of employees."

The vaccine contamination occurred when ingredients for the J&J vaccine were mixed with ingredients for the AstraZeneca vaccine, which was produced in the same plant. Last month, the government ordered no vaccine to be shipped from the factory and put J&J in charge of the factory.

Despite the problems, Emergent paid hundreds of thousands of dollars in bonuses to company executives.

Emergent CEO Robert Kramer received a $1.2 million bonus, the documents said, and three other executives received more than $400,000 each.

The report said the federal government had paid Emergent $650 million starting in May 2020 for plant improvements as the Trump administration rushed to set up production for vaccines. Emergent signed contracts with J&J, whose one-shot vaccine has been authorized for use in the United States, and AstraZeneca, whose vaccine has not been authorized.

"The Committees' investigation raises troubling new questions about the lucrative contract Emergent received under the Trump administration, the company's failure to address manufacturing problems that led to the destruction of millions of desperately needed coronavirus vaccine doses, and large bonuses paid to top executives despite these failures," the report said.

At a Wednesday committee hearing, Kramer said the company is working to fix the problems, including not making the AstraZeneca vaccine at the plant now, according to The Washington Post.  

"We have implemented an array of corrective steps,'' he said. "I apologize for the failure of our controls, and I give you my personal assurance that I will take every step that is needed to resume production safely.''

Kramer testified that the company faced many challenges in trying to manufacture vaccines at a fast pace during that period of the pandemic. He said Emergent made 80 changes in the manufacturing process, and some steps resulted in spoiled batches.

About 100 million vaccine doses made at the factory have been stored at the factory and are awaiting inspection by the FDA, Kramer said, according to The Post.

No vaccine made in the plant has been administered in the United States. The only J&J vaccine administered in the U.S. was made in Europe.

Sources:

House Select Subcommittee on the Coronavirus Crisis: "Preliminary Findings from Investigation into Emergent BioSolutions, Inc."

The Washington Post: "Johnson & Johnson documented contamination risks at Baltimore plant months before vaccine was ruined."

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