Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.
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Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.
During a quarterly financial call with investors Thursday, Chief Executive Officer Robert G. Kramer said he took full responsibility for the botched production of the Johnson & Johnson vaccine, and also the halted production of the AstraZeneca vaccine that has been not been authorized for use in the United States. Kramer said manufacturing biologics is tricky and product loss occurs for a number of reasons. However, he said the loss of a batch for a viral contamination is extremely serious. Kramer said the company believes the batch was contaminated after a failure of disinfection and other protocols implemented to prevent the cross contamination of vaccine ingredients.
“Importantly, our rigorous safety and quality protocols worked as designed, identifying this contamination batch to ensure they never left our facility. Much has been made about the choice to put two viral product candidates in one facility. Cross contamination is a well-known risk when producing drug substance for multiple viral products in a single plant, which is exactly why there are so many fail-safes and quality control measures in place,” Kramer said, according to a transcript of the call.
Kramer went on to explain the extraordinary circumstances that led to two vaccines being manufactured in the same facility. He said the company rose to the challenge to meet the public health crisis and despite best intentions and practices, errors occurred.
“For things we should have done differently, my leadership team and I bear full accountability, but I take issue with the unfair criticism of the dedicated team of more than 400 professionals in Baltimore Bayview have been -- who have been working literally night and day for over a year to make sure that vaccine can be available to the public. In all of this, they are no different from our frontline healthcare workers,” Kramer said.
Those mistakes are forcing a shift at the C-suite level. Syed Husain, head of Emergent’s Contract Development and Manufacturing Operations business unit is leaving the company to “pursue another opportunity.” Catherine Haley, who served under Husain, will take over the role on an interim basis while the company seeks a full-time replacement.
Sean Kirk, executive vice president of Manufacturing and Technical Operations, is taking a personal leave of absence. Kramer praised Kirk for his “laser focus” on the company’s response to COVID-19. But over the past 15 months, he said Kirk set aside important personal matters that now demand his attention.
Senior Vice President of Global Quality Mary Oates, who joined the company in November, is now reporting directly to Kramer. Oates, a veteran from companies like Pfizer and GlaxoSmithKline, is leading Emergent’s response to federal investigations into the company’s manufacturing facility in Baltimore where the mishap occurred.
With Kirk out for the foreseeable future, Adam Harvey, executive vice president of Business Operations, will assume full responsibility for manufacturing. Harvey will work alongside Oates on the remediation plan for the company’s Bayview facility.
Kramer said the company is working on solving the issues that led to the manufacturing error and believes the plans under discussion with the U.S. Food and Drug Administration will see the company returning to the manufacture of COVID-19 vaccines.
“What’s important now is getting an accurate account of the challenges we faced and using the lessons we learned to ensure that Emergent, the government and our other partners can be best prepared to get us out of this pandemic and ready for the next public health crisis,” Kramer said.
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