Emergent BioSolutions Inc., a multinational biopharmaceutical company, on Wednesday said it is on track to meet federal COVID-19 vaccine manufacturing standards and executives will testify during a congressional hearing next week on the company’s progress since a batch of the coronavirus vaccine became contaminated at its Baltimore facility.
Emergent Founder and Executive Chairman Fuad El-Hibri and Robert Kramer, president and CEO, will testify during a May 19 hearing held by the U.S. House Select Subcommittee on the Coronavirus. The subcommittee in April launched an investigation into whether the Gaithersburg, Md.-based Emergent leveraged its relationship with a key Trump administration official to profit from federal contracts and whether these actions impeded the nation’s response to the coronavirus crisis.
“We lobby the government about helping the country prepare for events that only a small group of public health experts are thinking about,” wrote Emergent’s CEO Kramer in an April 14 commentary published in The Baltimore Sun newspaper. “We don’t favor a party or administration. We try to educate both equally, and we’ve worked extremely well with both sides.”
During the May 19 hearing members said they plan to examine federal contracts awarded to Emergent to manufacture vaccines, quality control and staffing issues at the company’s Baltimore plant, as well as “the impact of these matters on the federal government’s response to the coronavirus crisis,” according to a letter the subcommittee sent to El-Hibri.
In April, it was learned that workers at Emergent’s Baltimore Bayview plant unintentionally contaminated ingredients while manufacturing the Johnson & Johnson and AstraZeneca coronavirus vaccines, resulting in the non-distribution of some 15 million vaccine doses.
“We recently had a setback that was not something we ever like to see,” Kramer wrote in his commentary. “During our rigorous quality control process, we found a batch of Johnson & Johnson vaccines that did not meet specification. In typical pharmaceutical manufacturing, this does occasionally happen. However, I recognize in a world where every dose is critical, this feels catastrophic.”
The situation prompted an inspection by the U.S. Food and Drug Administration (FDA), which made several observations concerning whether the Baltimore facility’s processes met federal requirements and standards.
In a statement released on Wednesday by Emergent, the company said it has responded to the FDA’s observations with a comprehensive quality enhancement plan.
“We have already started making improvements and we are fully committed to making the necessary short- and long-term enhancements to meet or exceed FDA’s standards,” according to Emergent’s statement. “We continue to have constructive, on-going dialogue with the FDA and Johnson & Johnson as we work on the path forward to release drug substance currently under evaluation and to resume production.”
“Our focus is on doing our part to help strengthen the global supply chain for Johnson & Johnson’s COVID-19 vaccine,” the company said.