Mr de Notaristefani, a former senior executive at two large pharmaceutical companies, spoke of “significant” staffing issues, writing that plans to increase staff appeared “insufficient to allow the company to manufacture at the required rate”.
He also noted that audits of the FDA and of the individual companies that had hired Emergent “highlighted the need for in-depth staff training and a strengthening of the quality function.”
Nonetheless, he wrote, “the organization has the necessary experience / skills” to develop its manufacturing. He wrote that “management is well informed and seems confident” and that with sufficient government oversight, “risks can be mitigated”.
At the time of the visit, Emergent was also planning to manufacture a third Covid-19 vaccine, developed by Novavax, but that company has since partnered with another manufacturer under a government-backed deal. “Offloading the Novavax program to a different facility will also help reduce the load on Emergent Bayview,” Mr. de Notaristefani wrote.
Emergent is a long-time federal entrepreneur in the field of biodefense. Sales of its anthrax vaccines account for nearly half of the national strategic stockpile of half a billion dollars annually for most of the past decade, The Times reported last month. This has left the government with less money for items needed in the event of a pandemic, and over the past year the shortage of basic medical supplies in stock has become a symbol of the government’s wasted response to coronaviruses.
Although the initial federal contract for the Baltimore plant required Emergent to demonstrate the full-scale manufacture of a pandemic influenza vaccine – viewed by health officials as a pressure test of its capabilities – Emergent does not. had not yet done so, The Times reported Monday. The company was at risk of defaulting on the original deal, which set a deadline of June 2020. The company also has separate deals with the two vaccine makers worth more than $ 875 million.
In an effort to fix the plant’s problems, federal officials simplified Emerg’s mission, limiting it to only the production of the Johnson & Johnson vaccine and forcing AstraZeneca to move its production lines elsewhere. Johnson & Johnson also now claims direct control over manufacturing, although the workforce at the Southeast Baltimore plant remains that of Emerg.