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Audit noted plant risks

New questions raised on vaccine production by CHRISTOPHER ROWLAND THE WASHINGTON POST | May 20, 2021 at 3:54 a.m.

WASHINGTON -- Johnson & Johnson documented contamination risks at a Baltimore biodefense plant in June, seven months before a contamination problem ruined 15 million doses of coronavirus vaccine and derailed Johnson & Johnson's domestic vaccine production, according to documents disclosed Wednesday by a House panel investigating the incident.

The disclosures by a House subcommittee on Wednesday raise questions about oversight by Johnson & Johnson as well as the Trump administration, which the newly released records show also knew of production risks at the Emergent BioSolutions facility.

The House Oversight select subcommittee on the coronavirus crisis, which is investigating the manufacturing failures by Emergent BioSolutions, released a staff report as part of a hearing Wednesday in which Emergent BioSolutions executives were scheduled to testify.

The report documented in new detail Emergent's persistent problems with contamination, unsanitary conditions, mold, poor training and insufficient attention to procedures.

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While Emergent has received most of the blame for the manufacturing crisis, the documents show that Johnson & Johnson was aware of risks of contamination at the plant. It conducted a virtual audit of the facility over several days in June. The audit report cited mold, inadequate gowning and wipe-down procedures and "deficient" contamination-control measures.

"The site virus contamination control strategy is deficient," the Johnson & Johnson audit report said. "There is not a formal Bayview contamination control strategy for the site."

Johnson & Johnson did not immediately respond to a request for comment Wednesday.

The New York Times previously disclosed that Johnson & Johnson made negative findings in the June audit, but the full document released by the committee contains previously unreported details.

Johnson & Johnson relied on Emergent as its only domestic manufacturer of coronavirus vaccine. The manufacturing shutdown at Emergent, triggered by a cross-contamination incident with the AstraZeneca vaccine in March and a subsequent Food and Drug Administration inspection that found a multitude of problems, has cut off supply in the U.S. of the single-shot vaccine.

Another report in June 2020 performed for the Trump administration by a consultant said Emergent's vaccine operations were put at significant risk by the need to rapidly add new workers and cited a lower-level risk associated with Emergent's "outdated" facilities.

The panel also released a detailed report by Emergent on how Johnson & Johnson discovered the contamination incident that ruined a huge amount of vaccine. The cross-contamination with a viral vector for AstraZeneca vaccine, which was being made in the same plant, was detected by Johnson & Johnson on March 5 in a batch of vaccine manufactured between Jan. 19 and Feb. 21, according to Emergent's report.

Emergent said the most probable route of contamination was during preparation of a growth media for the Johnson & Johnson vaccine, which came into contact with the "waste path" from an area used to make AstraZeneca vaccine.

Rep. James Clyburn, D-S.C., chairman of the select subcommittee on the coronavirus crisis, and Rep. Carolyn Maloney, D-N.Y., chairwoman of the House Committee on Oversight and Reform, opened an investigation April 19 and invited Emergent's CEO, Robert Kramer, and founder and executive chairman, Fuad El-Hibri, to testify.

"We have questions about why Emergent failed to take action to fix the manufacturing problems plaguing its plant -- even after the company was warned that its poor practices led to a very real risk of contamination," Clyburn said in prepared opening remarks the virtual hearing.

He added later during questioning of Kramer, "We are trying to find some accountability for what we consider some egregious failures."

Clyburn and Maloney questioned why the company awarded top executives with bonuses in 2020, given the documented problems. "I have serious concerns that Emergent executives ... appear to have wasted taxpayer dollars while lining their own pockets," Maloney said.

Kramer told the committee that Emergent was working with the FDA to get operations back on track.

"We have implemented an array of corrective steps," he said, including removing AstraZeneca production from the plant. "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 emphasized the high difficulty of manufacturing new vaccines in a matter of months. In attempting to make early batches of AstraZeneca vaccine in 2020, Kramer testified, Emergent had to make 80 changes in the production steps to correct problems, some of which resulted in spoiled batches.

Batches that do not meet specifications are fairly common in vaccine production, specialists have told The Washington Post, though cross-contamination of two vaccines ruining as much as 15 million doses is rare.

Emergent suspended production of the vaccine at the plant on April 19 at the request of the FDA and still lacks FDA manufacturing certification that would allow production to resume.

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