The analysis, which came on the heels of an April 2020 inspection by the Food and Drug Administration, said Emergent only had a fraction of the necessary experienced personnel to oversee quality control and technology transfer operations for Covid-19 vaccine production. The company had already agreed to manufacture J&J’s vaccine and was negotiating a similar deal with AstraZeneca.
The saga underscores the United States’ lack of contract manufacturing capacity to produce critical life-saving drugs and vaccines during a worldwide pandemic. It also raises questions about whether pharmaceutical companies or the federal government could have done more to prevent contamination at Emergent given its critical role fighting a global public-health emergency…
Despite the early and detailed warnings, former federal officials say there were few companies that had the capacity to help produce Covid-19 vaccines and Emergent was a natural pick for the job. The company also had long ties to Kadlec from his previous contracting work and had earlier picked up a profitable federal contract to produce smallpox vaccines, The Washington Post reported last year.
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