The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of doses coronavirus vaccine doses, also apologized during his first testimony before Congress.,


Continue reading the main story

More than 100 million J.&J. doses are on hold as U.S. regulators inspect them, an executive testifies.

Wednesday marked the first time that Emergent BioSolutions executives have publicly defended the company amid continuing questions about its manufacturing capability and whether it has leveraged its connections in Washington to win lucrative government contracts.Credit…Saul Loeb/Agence France-Presse — Getty Images

May 19, 2021, 1:42 p.m. ET

The chief executive of Emergent BioSolutions, whose Baltimore plant ruined millions of coronavirus vaccine doses, disclosed for the first time on Wednesday that more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for potential contamination, and apologized to members of Congress.

“No one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine,” the chief executive, Robert G. Kramer, told members of a House subcommittee that is investigating his firm, adding, “I apologize for the failure of our controls.”

Mr. Kramer’s appearance before the House Select Subcommittee on the Coronavirus Crisis marked the first time that company executives have publicly defended Emergent amid continuing questions about the firm’s manufacturing capability and whether it has leveraged its connections in Washington to win lucrative government contracts.

In more than three hours of testimony, Mr. Kramer acknowledged unsanitary conditions, including mold, at the Baltimore plant; conceded that Johnson & Johnson — not Emergent — had discovered the potential contamination; and fended off aggressive questions from House Democrats about his stock sales and hundreds of thousands of dollars in bonuses for top company executives last year.

Under aggressive questioning by House Democrats, he said he expects the Baltimore plant, which was forced to halt operation a month ago after contamination spoiled the equivalent of 15 million doses, to resume production “in a matter of days.” He said he took “very seriously” a recent Food and Drug Administration inspection showing unsanitary conditions — including mold — in the plant, and conceded that quality tests by Johnson & Johnson, not Emergent, had identified the contamination that forced Emergent to discard so many doses.

“My teenage son’s room gives your facility a run for its money in terms of its cleanliness,” Representative Raja Krishnamoorthi, Democrat of Illinois, told Mr. Kramer at one point.

Mr. Kramer’s estimate added another 30 million doses to the number of Johnson & Johnson doses that remain on hold because of regulatory concerns about the contamination at the plant. Federal officials had previously estimated that the equivalent of about 70 million doses of that vaccine — most of them destined for domestic use — could not be released until further tests are conducted for purity. So far, the federal government has paid Emergent more than $271 million but American regulators have not released a single dose of vaccine manufactured at Emergent’s plant for use by the American public.

Mr. Kramer, who testified virtually, was joined at the hearing by Fuad El-Hibri, the company’s founder and executive chairman, who also expressed contrition.

“Let me be clear,” Mr. El-Hibri declared. “The cross-contamination incident is unacceptable. Period.”

House Democrats launched a broad inquiry into Emergent after The New York Times documented months of problems at the plant, including failure to properly disinfect equipment and to protect against viral and bacterial contamination. Committee staff released a series of confidential audits, previously reported by The Times, that found a range of violations of manufacturing standards as well as a June 2020 report by a top federal manufacturing expert warning that Emergent lacked trained staff and adequate systems for quality control.

Lawmakers are looking into whether company officials leveraged relationships with the Trump administration to win a $628 million federal contract, and whether Emergent executives accepted the award despite known deficiencies. They are also looking at Mr. Kramer’s sale of $10 million worth of Emergent stock this year, and at hundreds of thousands of dollars in cash bonuses Emergent’s board awarded to its top executives.

Representative Carolyn Maloney, Democrat of New York, complained that Emergent officials “appear to have wasted taxpayer dollars while lining their own pockets.” Mr. Krishnamoorthi asked Mr. Kramer sharply if he would consider turning over his $1.2 million bonus from 2020 to the American taxpayers.

“Congressman, I will not make that commitment,” Mr. Kramer replied evenly.

“I didn’t think so,” Mr. Krishnamoorthi shot back.

As to his stock trades, Mr. Kramer said they were “made pursuant to a plan that was approved by the company” and put in during “a quiet period that was also approved by the company.” He added, “My participation was completely removed from those trades.”

Early in the hearing, Mr. Kramer testified that the possible contamination of the Johnson & Johnson doses “was identified through our quality control procedures and checks and balance.” But under questioning, he later acknowledged that it was picked up by a Johnson & Johnson lab in the Netherlands.

While Democrats pressed Mr. Kramer for information about vaccine manufacturing, Republicans sought to defend the company, and tried to change the subject by talking about the unproven theory that the coronavirus emerged from a laboratory in China, the “lies of the Communist Party of China” and mask mandates, as well as the Biden administration’s call for a waiver of an international intellectual property agreement, which is strongly opposed by the pharmaceutical industry.

“You are a reputable company that has done yeoman’s work to protect this country in biodefense!” Representative Mark Green, Republican of Tennessee, exclaimed at one point, adding, “So you gave your folks a bonus for their incredible work.”