Emergent BioSolutions CEO: We take ‘full responsibility’ for vaccine mishap

Emergent BioSolutions executives said Wednesday they accept full responsibility for spoiling millions of COVID-19 vaccine doses at a Baltimore plant and pledged to fix problems with “diligence” and “urgency” amid the pandemic.

“No one is more disappointed than we are that we had to suspend our 24-7 manufacturing of new vaccine. As CEO, I take full responsibility for that,” Emergent President and CEO Robert G. Kramer told the House Subcommittee on the Coronavirus Crisis and House Oversight Committee. “I apologize for the failure of our controls and I give you my personal assurance that I’ll take every step that’s needed to resume production safely.”

Emergent made headlines in March after workers at a Baltimore plant exposed ingredients of the J&J vaccine to those used in a version from AstraZeneca, which also uses an adenovirus-vector but is not identical. The company’s also been the subject of unflattering inspection reports from the Food and Drug Administration.

Mr. Kramer said it was difficult to say how much J&J vaccine was lost but the mishap impacted “one batch” — typically equivalent to 15 million doses.

He also said it was the government’s idea in mid-2020 to carve out space at the Bayview facility for AstraZeneca alongside the J&J version.

“Ramping up production of two novel vaccines at a very large scale in the same facility is unprecedented. But the government decided that given the critical need, Emergent should manufacture both drug substances simultaneously,” Mr. Kramer said.

The Biden administration put J&J in total control of the Baltimore plant as it tries to restore a steady supply of the J&J vaccine and run checks on the AstraZeneca doses that it wants to send to other countries.

“The vaccinations of millions of people around the world have been delayed,” said Rep. James E. Clyburn, South Carolina Democrat and chairman of the coronavirus subcommittee

Mr. Clyburn said it was clear from 2020 inspection reports that its Bayview plant in Baltimore had problems, yet company executives received bonuses in subsequent months.

House Oversight Committee Chairwoman Carolyn B. Maloney said Emergent made a commitment to the American people when it accepted a $628 million federal deal on June 1 to manufacture COVID-19 vaccines and therapeutics.

“Unfortunately, the company has failed to live up to that commitment,” the New York Democrat said.

“Have we gotten any vaccines out of your company that we can use? Yes or no?” Mrs. Maloney asked Mr. Kramer.

“None of the vaccine that we’ve manufactured has been made available to the U.S.,” the CEO said after trying to give a more nuanced answer.

Majority Democrats repeatedly steered the hearing toward audits that found quality failures in 2020 and suspicions that personal ties with the Trump administration influenced the federal contracts awarded to Emergent.

Fuad El-Hibri, executive chairman of Emergent, rejected claims his close relationship with Robert Kadlec, a former consultant to Emergent and a high-ranking official in Mr. Trump’s Health and Human Services Department, impacted the awards.

“This is simply not true,” Mr. El-Hibri said.

Mr. Kramer said he is not aware of any “direct contact” with Mr. Kadlec, noting the COVID-19 contract went through a separate federal channel: the Biomedical Advanced Research and Development.

Committee Republicans, meanwhile, pointed to the speed of vaccine development under Mr. Trump and the need to protect those innovations as Mr. Biden discusses patent waivers with global partners.

House Minority Leader Steve Scalise also noted that spoiled doses did not reach the public.

GOP members used their opening statements to highlight other pandemic issues, including confusing mask guidance and whether teacher unions have undue sway over the Centers for Disease Control and Prevention.

Rep. Jim Jordan, Ohio Republican, said the committee should be focused on whether the virus hopped from animals to humans or if it escaped from a lab in China.