Emergent Biosolutions in Baltimore is under scrutiny by U.S. House lawmakers after mishaps caused the company to dump millions of COVID-19 vaccine doses. Photo from the executive office of Maryland Gov. Larry Hogan.
WASHINGTON — Angry U.S. House Democrats on Wednesday had one key question as they grilled executives of a Maryland biotech manufacturer forced to dump 15 million doses of Johnson & Johnson’s COVID-19 vaccine: Has there been one usable vaccine dose produced as a result of the $271 million paid to date by the U.S. government?
The answer is no, Emergent BioSolutions chief executive officer Robert Kramer acknowledged when pressed during a hearing of the House Select Subcommittee on the Coronavirus Crisis.
“None of the vaccine that we’ve manufactured has been made available to the U.S.,” Kramer said. Quality control errors have plagued the rollout.
Kramer and Emergent’s founder and executive chairman, Fuad El-Hibri, faced an onslaught of questions from Democratic lawmakers during Wednesday’s hearing about the circumstances surrounding the company’s cross-contamination of the substance used to produce doses of J&J’s one-shot coronavirus vaccine at its Baltimore facility.
The nearly 10 million J&J shots administered in the United States to date have been imported from the company’s plant in the Netherlands.
The incorrect vaccine doses from Emergent were never distributed or administered after being discovered in late March, but the loss was particularly painful at a point when U.S. vaccine demand still outstripped supply.
Production at the plant has remained on hold pending approval from federal regulators.
Lawmakers on the panel also questioned how Emergent was granted an overall $650 million federal contract to boost domestic vaccine production capabilities, of which $271 million has been paid out to date on a monthly basis.
They also asked about the timing of bonuses to and stock sales by top company officials as the Baltimore plant struggled with production and discarded several batches of substance needed for the AstraZeneca COVID-19 vaccine last fall.
“As they’re destroying the vaccines, they’re cashing out, taking stock out of the company,” said Rep. Carolyn Maloney, D-N.Y., referencing news reports that Kramer sold $11 million in stock between January and February, prior to the stock price plummeting.
Ahead of the hearing, Democrats on the panel released a memo Wednesday morning detailing initial findings from the committee’s investigation into company operations.
Among the new findings were documents detailing the federal contract that paid Emergent $27 million a month to reserve manufacturing space, regardless of whether the company produced vaccines.
Other documents showed a Trump administration adviser flagged risks at the Emergent plant in June 2020, highlighting “inadequate” staffing plans and the need for “substantial remediation and expansion” of equipment before production could begin.
The memo also detailed at least $360,000 in consulting fees received by Dr. Robert Kadlec, a senior Trump administration official contracted by Emergent from 2012 to 2015, and the bonus received by its executive vice president responsible for manufacturing amid issues at the Baltimore plant.
Emergent’s executives defended their bonuses and stock sales, and denied any political impropriety by Kadlec in connection with the company’s work with J&J and AstraZeneca.
Kramer attributed the cross-contamination of the J&J doses to the rapid pace at which the company attempted to scale up production of not one, but two brand-new vaccines when it was not yet fully staffed.
The company has taken steps to prevent such contamination in the future, including no longer producing AstraZeneca material at the Baltimore facility, he said, adding that J&J officials also are now providing 24-7 oversight of its production.
“I apologize for the failure of our controls, and I give you my personal assurance that I’ll take every step that is needed to resume production safely,” Kramer told the panel.
The company’s struggles came to public view in late March, when quality control checks revealed cross-contamination at that facility, which was producing substances to be used in vaccine doses from both J&J and AstraZeneca.
In April, Food and Drug Administration investigators flagged a series of shortcomings at the plant, including failure to properly disinfect equipment and improperly training employees.
Kramer said the company’s internal review indicates that the cross-contamination occurred when substances transported from the part of the facility that produces the AstraZeneca materials “came in the general vicinity” of where the J&J materials are produced.
Republicans on the panel had few critical questions for the Emergent executives, largely focusing instead on criticizing the House’s mask mandate and President Joe Biden’s decision to waive intellectual property protections for COVID-19 vaccines in order to boost global access to those shots.
Rep. Steve Scalise, R-La., the ranking GOP member on the subcommittee, used his questions to underscore that quality control checks caught the contamination and that none of the material left the facility.
Scalise also criticized the FDA for not acting faster to approve use of an estimated 100 million doses’ worth of J&J vaccine substance in batches deemed free of contamination.
“If both Emergent’s and Johnson & Johnson’s internal reviews have said that those 100-plus million doses are OK, why hold them up?” he asked.
Scalise is one of three lawmakers on the panel who have received campaign contributions from Emergent executives, according to the New York Times. He and his campaign organizations received at least $150,000 since 2018.
Rep. Jim Jordan, an Ohio Republican, and Rep. Jamie Raskin, D-Md., each received $1,000 during the 2020 election cycle from the company’s political action committee. Raskin told the Times that he had returned the money after being contacted about the contribution.
During Wednesday’s hearing, Raskin pressed Emergent executives on the price tag and requirements of the contract, as well as the circumstances of the contamination, describing that as “a catastrophic failure.”
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