Emerging Biosolutions Executives Address Questions From Lawmakers In Vaccine Investigation

Besieged biotech firm Emergent Biosolutions will face a congressional investigation on Wednesday, scrutinized for what investigators say are the “serious shortcomings” in their manufacture that have led to up to 15 million doses of COVID-vaccine ingredients. 19 compromised and eliminated due to cross contamination.

Top emerging executives Fuad El-Hibri, founder and executive chairman of the company, and Robert Kramer, its CEO, will appear on Capitol Hill as part of a congressional inquiry into their company’s manufacturing issues and the issue of Whether the company leveraged its ties to the Trump administration improperly secured its multi-million dollar pandemic contract.

Emergent highlighted its long-standing work with federal leaders of all political stripes and underlined the urgency of the pandemic backdrop – that “the rapid ramp-up of manufacturing has never been done before in the history of the planet, “said a spokesperson. mentionned.

“Emergent has carried out many vital missions for the United States government since its founding in 1998, and especially since the nation focused on the critical importance of biodefense after the 9/11 terrorist attack and attacks. anthrax that followed, ”a spokesperson said in a statement to ABC. News Wednesday morning. “We look forward to clarifying misconceptions and addressing the Committee’s concerns.” For now, we are focused on the way forward to release the drug substance currently under evaluation, resume production, and do our part to help strengthen Johnson’s global supply chain. And Johnson’s COVID-19 vaccine. “

The Special House Subcommittee on Coronavirus, chaired by Rep. Jim Clyburn, DS.C., and the House Committee on Oversight and Reform, chaired by Rep. Carolyn Maloney, DN.Y. announced last month that they were opening an investigation into the company. On Wednesday morning, ahead of Kramer’s and El-Hibri’s appearance on the Hill, the committee released preliminary findings that should be questioned as the couple clash with lawmakers.

“Committees’ investigation raises troubling new questions about the lucrative contract Emerging received under the Trump administration, the company’s inability to resolve the manufacturing issues that led to the destruction of millions of doses of the vaccine desperately needed anti-coronavirus, and large bonuses paid to top executives despite this failures, ”according to a staff memo distributed ahead of the hearing.

The Johnson & Johnson single dose vaccine relies on an essential viral vector component manufactured by Emergent and other international facilities. Emergent is one of the few facilities in the US capable of producing this crucial ingredient and is the primary US supplier to Johnson & Johnson’s US production line. Emergent was supposed to deliver millions of doses of this key ingredient – but currently none of them can leave the company’s Baltimore plant as production is halted due to cross-contamination concerns.

However, the recent cross-contamination at the Baltimore plant is not the first time Emerg has had to answer questions about its quality control.

ABC News has previously reported on the company’s long-standing quality control issues, detailed in federal inspection reports over more than a decade, including leaks and cracks in critical equipment, mold, peeling paint, stained ceiling tiles, inadequate staff training and IT. infrastructure left vulnerable to data compromise, which was observed by on-site investigators and flagged for immediate remediation.

In a private report in June 2020, a federal government advisor to Operation Warp Speed ​​identified key “risks” in leveraging Emerging’s facility in Baltimore to manage the production of vaccine ingredients, affirming that Emergent “will have to strengthen the process of change control, systems auditing and quality monitoring”, which “would require significant resources and commitment”.

“Emergent was aware of the problems and did not take sufficient action,” the House subcommittee said in its preliminary report, noting what it calls the “scathing inspection report” released by the FDA. later than April 2021.

Despite the litany of quality control issues, Emergent won a $ 628 million contract from the Trump administration in June 2020 to build domestic vaccine manufacturing capacity, making it one of the most successful partners. of the federal government in the manufacture of vaccines in the United States.

Emergent says identifying deficiencies is part of the regulatory process – especially for the “difficult and complex” products they make – and that the company is under unprecedented pressure from the pandemic.

“There are a lot of complex and detailed steps involved,” Emerging CEO Robert Kramer said during a call in late April with investors. “We took a process that normally takes years and condensed it into months… I’m proud of the fact that we got into this process and did all we could, all we could now, to support and stabilize this supply chain. And we would absolutely do it again. “

Lawmakers are expected to investigate Wednesday the involvement of Dr Robert Kadlec, former senior adviser to President Donald Trump, in awarding the coronavirus vaccine contract to Emergent. The committee’s note stated that Kadlec had personally vouched for Emergent and “requested in August 2020 that Emergent’s contract be given a ‘priority rating’.”

Prior to joining the Trump administration, however, Kadlec accepted more than $ 360,000 in consulting fees from Emerging, according to documents released by the committee.

“These documents raise further questions about Dr. Kadlec’s role in awarding major contracts to Emergent during the Trump administration,” the committee wrote in the staff memo.