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House Democrats on Wednesday questioned Emergent BioSolutions executives on how millions of Johnson & Johnson COVID-19 vaccine doses were botched at the company's Baltimore manufacturing plant earlier this year.

Company CEO Robert Kramer also revealed to lawmakers, during a of the House Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform, that more than 100 million Johnson & Johnson shots have been held up by FDA for inspection due to contamination concerns.

Democratic lawmakers also raised the specter of possible insider trading, and questioned whether Robert Kadlec, MD, the former Assistant Secretary for Preparedness and Response at HHS, as well as a former consultant to Emergent, helped to win the company the $628 million no-bid contract to manufacture COVID-19 vaccines.

Wasted Doses

In February, Emergent employees with that of AstraZeneca's at the company's Bayview facility in Baltimore.

"Exactly how many doses ... were destroyed due to contamination at your plant?" asked Rep. James Clyburn (D-S.C.).

Kramer pegged the number of Johnson & Johnson doses at approximately 15 million, but acknowledged that during "the early stages of manufacturing" there had been a "number of lost batches," in particular of AstraZeneca due to the accelerated pace of starting up and producing the vaccines.

"We were really working at [an] unprecedented pace," said Kramer.

Fuad El-Hibri, executive chairman for Emergent's board of directors, said the cross-contamination event was "unacceptable," but stressed the odds the company was up against.

"Manufacturing drug substance for two viral products in one facility on a massive scale, while incorporating new manufacturing technology into the facility" would have been difficult under ordinary circumstances, then factor in a public health emergency, El-Hibri said.

To address the problem, Emergent BioSolutions developed a special committee dedicated to manufacturing and oversight, changed the reporting structure of the organization, and overhauled the management of oversight at the Bayview facility.

But Democrats did not seem to sympathize with the company's struggles.

"Because the company was unable to deliver [on its contract], the vaccinations for millions of people around the world have been delayed, putting their lives at needless risk," said Clyburn, who chairs the Select Subcommittee on the Coronavirus Crisis.

Clyburn cited a staff memorandum that revealed "multiple warnings" of serious manufacturing problems and an "inadequate contamination control strategy."

Rep. Carolyn Maloney (D-N.Y.), who chairs the Committee on Oversight and Reform, pointed out that reports of contamination had been found by Johnson & Johnson as early as June 2020.

Kramer said the company took action in response to the findings, but Maloney interrupted before he could provide more details. Regardless, millions of vaccine doses still had to be destroyed as a result, she said.

Stock Moves Questioned

While Emergent was destroying millions of vaccine doses, and before the error was made public, "you entered into a plan to dump over 10 million of your own company's stock, which you knew were going to go down," said Maloney. "That makes me think you were more interested in enriching yourself than serving the public."

"Appears to be insider trading," suggested Rep. Maxine Waters (D-Calif.). "I think we know enough about Emergent not to trust them."

Kramer said all of his stock sales were made "pursuant to a plan that was approved by the company" during a "quiet period." Once the plan was filed he was "completely removed from the execution of those trades," he said.

Maloney also highlighted the waste to taxpayers.

Emergent was given a $628 million contract, of which $271 million has been taken, and yet not a single American has been given a vaccine.

"Yes or no? Have we gotten any vaccines out of your company that we could use?" she asked.

Kramer conceded that none of the vaccines manufactured by Emergent were made available in the U.S. At one point during the hearing he noted that "probably over 100 million doses" of the Johnson & Johnson vaccine are being evaluated by the FDA for potential release.

'Eyes Wide Open'

Other committee members including Rep. Raja Krishnamoorthi (D-Ill.) remarked on an FDA report that referenced "brown ... and black residue" on plant walls.

"My teenage son's room gives your plant a run for its money in terms of its cleanliness," he said.

El-Hibri, at one point in the hearing, found an opening to defend his company, suggesting that certain problems with the plant were known in advance of the contract.

"Everyone went into this with their eyes wide open," he said of AstraZeneca, Johnson & Johnson, and the Biomedical Advanced Research and Development Authority (BARDA), which was charged with developing the partnership. Despite the fact that the facility was "not in perfect condition" it had "the highest level of state of readiness," he said.

As to the claim that Kadlec, a former consultant for Emergent, used his influence to help Emergent land a contract, El- Hibri argued that this was "simply not true."

"Emergent's contracts with the U.S. government have all been subject to standard government contracting procedures, overseen by independent career government contracting officers," El- Hibri said.

IP Concerns

Republicans at the hearing sought to shift the discussion to President Biden's proposal to eliminate intellectual property rights for vaccines, arguing that sharing such information with the Chinese government would make America less safe.

"Handing them this technology on a silver platter is a threat to national security," said Rep. Mark Green, MD (R- Tenn.).

Republicans also argued that millions more vaccine doses awaiting FDA inspection could be donated abroad instead, on top of the 80 million already promised.

"Why don't we allow those to get out and [be] used instead of giving the entire intellectual property away?" asked Ranking Member Steve Scalise (R-La.)

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