Mr de Notaristefani, a former senior executive at two large pharmaceutical companies, cited “significant” staffing problems and wrote that plans to increase staff were “insufficient to enable the company to produce at the required speed”.
He also noted that audits by the FDA and individual companies hiring Emergent “highlighted the need for extensive staff training and strengthening the quality function.”
Nonetheless, he wrote: “The organization has the necessary experience / competence” to expand its manufacturing. He wrote that “management is knowledgeable and appears confident” and that with adequate 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. Since then, this company has partnered with another manufacturer. “Offloading the Novavax program to another facility will also help ease the burden on Emergent Bayview,” wrote de Notaristefani.
Emergent is a longtime federal entrepreneur in the biological defense field. Sales of its anthrax vaccines accounted for nearly half of Strategic National Stockpile’s annual budget of half a billion dollars for most of the past decade, The Times reported last month. This left the government with less money on items needed during a pandemic, and last year the lack of basic health care in inventory became a symbol of the government’s botched coronavirus response.
Although the original federal contract for the Baltimore plant required Emergent to demonstrate large-scale manufacture of a pandemic influenza vaccine – designated by health officials as a pressure test of its capabilities – Emergent had yet to do so, The Times reported Tuesday. The company risked default on the original contract, which set a deadline of June 2020. The company also has separate agreements with the two vaccine makers valued at more than $ 875 million.
In an effort to resolve the factory’s problems, federal officials simplified Emergent’s mission, narrowing it down to making Johnson & Johnson’s vaccine, and forcing AstraZeneca to relocate its production lines. Johnson & Johnson now also maintains direct control of manufacturing, although the workforce at the facility in southeast Baltimore remains with Emergent.