De Notari Stefani, a former CEO of two major pharmaceutical companies, said “serious” human problems and plans to increase staff are “insufficient for the company to manufacture at the speed it needs.” Said.
He also said that audits by individual companies that adopted the FDA and Emergent “emphasized the need for extensive training of human resources and enhanced quality capabilities.”
Nonetheless, he writes that “organizations have the necessary experience / ability” to scale up manufacturing. “Management appears to be knowledgeable and confident,” he said, “with close government oversight,” risk can be mitigated. “
At the time of the visit, Emergent also planned to produce a third Covid-19 vaccine developed by Novavax, which has since partnered with another manufacturer with government support. “Offloading the Novavax program to another facility can also help offload Emergent Bayview,” writes de Notaristefani.
Emergent is a longtime federal contractor in the field of biodefense. Anthrax vaccine sales accounted for almost half of the $ 500 million annual budget of strategic national stockpiles for most of the last decade. Times reported last month. As a result, the government needed less money for the items needed for the pandemic, and last year the shortage of basic medicines in stockpiles symbolized the government’s failure to respond to the coronavirus.
The original federal contract for the Baltimore plant required Emergent to demonstrate the large-scale production of a pandemic flu vaccine, which health officials envisioned as a pressure test of its capacity, but Emergent is still I didn’t do that. Reported Times on Monday. The company was at risk of defaulting on its original transaction, which was due in June 2020. The company also has separate contracts with two vaccine manufacturers worth more than $ 875 million.
To solve factory troubles Federal authorities It simplified Emergent’s mission, limiting it to Johnson & Johnson vaccine production only, and forced AstraZeneca to move its production line to another location. Johnson & Johnson also claims to be in direct control of manufacturing now, but the workforce at the factory in southeastern Baltimore is still emergent.
Top officials warn that Covid vaccine plant needs to be “closely monitored”
Source link Top officials warn that Covid vaccine plant needs to be “closely monitored”