Mr De Nauteristefani, a former top executive at two major pharmaceutical companies, wrote that the plan to increase staffing seemed “inadequate to enable the company at an inadequate rate”, citing “significant” personnel problems.
He also mentioned that the audit was appointed by FDA and individual companies to Amergent, “highlighting the need for extensive training of personnel, and strengthening the quality function.”
However, he wrote, “the organization has the necessary experience / capability to enhance its manufacturing”. He wrote that “management is knowledgeable and shows self-confidence,” and with adequate government oversight, “risk can be reduced.”
At the time of the visit, Amergent also planned to build a third Kovid-19 vaccine developed by Novavax, but the company has since partnered with another manufacturer in a government-backed deal. “Loading the Novax program into a separate facility will also help reduce the load on Emergent View,” Mr. de Notaristani wrote.
Emergent is a long-term federal contractor in the field of biodefense. Its anthrax vaccine sales accounted for nearly half of the Strategic National Stockpill’s half-billion dollar annual budget during most of the last decade. The Times reported last month. This left the government with less money for essential goods in an epidemic, and last year, the stockpill shortage in basic medical supplies became a symbol of the government’s blighted coronavirus response.
Although the original federal contract for the Baltimore plant required Emergent to demonstrate large-scale manufacture of the pandemic influenza vaccine – conceived by health officials as a pressure test of its capabilities – Amergent had yet to do so, The Times reported on Tuesday. The company risked defaulting on the original deal, which set a deadline of June 2020. The company has also entered into separate agreements worth more than $ 875 million with the two vaccine manufacturers.
In an effort to solve the factory’s troubles, Union official Has simplified Emergent’s mission, forcing it to produce only Johnson & Johnson’s vaccine, and AstraZeneca to move its production lines elsewhere. Johnson & Johnson is also now claiming direct control over manufacturing, although the work force at the plant in southeast Baltimore remains of Emergent.