The top two executives of Emergent BioSolutions Inc. on Wednesday promised to provide additional documentation requested by congressional lawmakers who are investigating the Maryland-based biopharmaceutical company’s failure to manufacture usable coronavirus vaccines under a contract with the United States government.
Emergent President and Chief Executive Officer Robert Kramer and Fuad El-Hibri, Emergent’s founder and executive chairman, testified during a May 19 hearing held by the U.S. House Select Subcommittee on the Coronavirus Crisis, which along with the U.S. House Oversight and Reform Committee is investigating Emergent for several manufacturing and government contract issues. Most recently, Emergent had to dump roughly 15 million doses of the Johnson & Johnson vaccine that it was manufacturing following cross contamination with the AstraZeneca vaccine that it was also producing at its Baltimore Bayview plant.
“Manufacturing drug substance for two viral products in one facility on a massive scale while incorporating new manufacturing technology into the facility is a challenge at any time, even more so in the midst of a public health emergency,” El-Hibri said during his opening statement. “Let me be clear: the cross-contamination incident is unacceptable. Period.”
“I can assure you that no one is more disappointed than we are that we had to suspend our 24/7 manufacturing of new vaccine,” Kramer testified. “As CEO, I take full responsibility for that.”
Emergent, which is focused on public health threats that pose an extraordinary danger to the nation, such as bioterror weapons, has a current portfolio comprised of vaccines and therapies for anthrax, smallpox, typhoid fever, cholera, and botulism, and produces the Narcan nasal spray product, which reverses opioid overdoses.
Following the 2009 H1N1 pandemic, the Biomedical Advanced Research and Development Authority (BARDA), which has awarded several contracts to Emergent, recognized that the United States lacked sufficient domestic capability to rapidly manufacture vaccines in quantities that would meet the demands of a pandemic emergency, according to Kramer’s testimony.
In response, BARDA funded three centers for innovation and advanced development and manufacturing, or CIADM, and in 2012, Emergent’s Bayview operation was selected as one of those facilities.
However, despite Emergent’s own investment of more than $200 million, Kramer said the expected pipeline of government task orders to utilize the facility persistently fell short of what was needed to reach full operating potential.
“As a result, by the end of 2019, Bayview had roughly 100 employees and was less than a year away from licensure,” he said. “When the COVID-19 pandemic began, Emergent, the U.S. government and our other partners recognized that while Bayview was not yet fully staffed or operating at scale, the facility’s unique attributes could be used to support the challenge of producing mass amounts of vaccine.”
So, in April 2020, Emergent agreed to manufacture a drug substance for the Johnson & Johnson COVID-19 vaccine candidate at Bayview. In late May 2020, the government issued a task order under the CIADM contract requiring Emergent to reserve additional Bayview capacity and the company was later directed to release that capacity to AstraZeneca, Kramer testified.
“Ramping up production of two novel vaccines on 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,” said Kramer. “We moved with extraordinary speed to scale up the new technology.”
Emergent in August 2020 started manufacturing the drug substance for AstraZeneca and in November 2020 did the same for Johnson & Johnson, he said.
“However, in March of 2021, a single batch of J&J’s COVID-19 vaccine candidate failed routine quality control testing,” said Kramer. “We immediately initiated an investigation. It was determined that the bioreactor material used for the J&J program was in the vicinity of material being disposed of from the AstraZeneca suite.”
Kramer explained that Emergent has implemented an array of corrective steps and removed the AstraZeneca vaccine candidate from its Bayview facility, which is now dedicated only to the Johnson & Johnson vaccine. And he said that Johnson & Johnson has been on-site with Emergent throughout the pandemic and now provides 24/7 oversight of all production areas, change controls, qualifications, and processed items.
”I understand that we’re here today to answer for the contamination incident, and I apologize for the failure of our controls, and I give you my personal assurance that I’ll take every step as needed to resume the production safely,” testified Kramer.
The cross-contamination event resulted in more than 15 million doses of the Johnson & Johnson vaccine being contaminated and Emergent was forced to stop its coronavirus vaccine production process. However, Kramer told lawmakers that the Baltimore plant was expected to resume production within days.
Some 100 million more J&J doses manufactured by Emergent currently can’t leave the Bayview facility until approval by the Food and Drug Administration (FDA).
“I would like to emphasize that Emergent takes very seriously its role as a reliable supplier of medical countermeasures, vaccines and therapeutics for public health threats to the U.S. government and patients,” El-Hibri testified. “We remain very focused on addressing the manufacturing challenges at the Bayview facility, and the board’s top priority is ensuring that management takes all corrective actions required to resume production.”
In response to the cross contamination, U.S. Rep. James Clyburn (D-SC), chairman of the House Select Subcommittee on the Coronavirus Crisis, and U.S. Rep. Carolyn Maloney (D-NY), chairwoman of the House Oversight and Reform Committee, on April 19 sent a letter to Emergent executives notifying them that they were launching an investigation.
They acknowledged that the cross contamination did not affect the safety and efficacy of vaccines available to the public because none of the coronavirus vaccines produced at Emergent’s Bayview site were distributed to the public. And the FDA asked and Emergent agreed to pause vaccine manufacturing at the plant.
Nevertheless, the lawmakers said that the Oversight Committee and the Select Subcommittee “have serious concerns” regarding the contracts awarded to Emergent. During Wednesday’s hearing, they said they want to determine whether Emergent leveraged its relationship with a key Trump administration official to profit from federal contracts despite its track record of raising prices and not meeting contract requirements. They also want to determine whether such actions impeded the nation’s response to the coronavirus pandemic, Clyburn said during the hearing.
“Now I want you to understand, we are not second-guessing anything here,” Clyburn said during the hearing he chaired. “This committee is really trying to find some accountability for what we consider to be some egregious failures.”
For instance, Democratic lawmakers noted during the hearing that they are investigating reports that Emergent received multimillion-dollar contracts to manufacture coronavirus vaccines despite its history of inadequately trained staff and quality control issues. They also pointed out that Dr. Robert Kadlec, who served as Assistant Secretary for Preparedness and Response under former-President Donald Trump and previously worked as a consultant for Emergent, appears to have pushed for the award despite indications that Emergent did not have the ability to reliably fulfill the contract.
“We would also like to address the suggestion that my personal relationship with Dr. Robert Kadlec influenced the award of government contracts to Emergent,” El-Hibri testified. “This is simply not true.”
Dr. Kadlec has had a distinguished career in public, private and military capacities working on biodefense issues, said El-Hibri, and outside of Kadlec’s government work, he was a valued consultant to Emergent and others. “Emergent’s contracts for the U.S. government have all been subject to standard government contracting procedures overseen by independent, career government contracting officers,” El-Hibri added.
Also Wednesday, ahead of testimonies by Kramer and El-Hibri, the two committees released preliminary findings in their investigation that lawmakers said raise “troubling new questions” about all of these issues.
As part of their ongoing investigation, Rep. Maloney asked both Emergent executives if they would commit to both providing overdue documents to the committees, as well as to testify again about the suggested issues.
Both Kramer and El-Hibri said under oath that each of them would testify and assured them that other relevant, requested documents would be provided.
“I would like to emphasize that Emergent takes very seriously its role as a reliable supplier of medical countermeasures, vaccines and therapeutics for public health threats to the U.S. government and patients,” El-Hibri said. “We remain very focused on addressing the manufacturing challenges at the Bayview facility and the board’s top priority is ensuring that management takes all corrective actions required to resume production.”