Top Official Warned That Covid Vaccine Plant Had to Be ‘Monitored Closely’

Mr. de Notaristefani, a former top executive at two major pharmaceutical companies, cited “significant” personnel problems, writing that plans to increase staffing seemed “inadequate to enable the company to manufacture at the required rate.”

He also noted that audits by the F.D.A. and individual companies that had hired Emergent “highlighted the need for extensive training of personnel, and strengthening of the quality function.”

Nonetheless, he wrote, “the organization has the necessary experience/competence” to scale up its manufacturing. He wrote that “management is knowledgeable and appears self-confident,” and with enough government oversight, “risks can be mitigated.”

At the time of the visit, Emergent also planned to make a third Covid-19 vaccine, developed by Novavax, but that company has since partnered with another manufacturer in 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 longtime federal contractor in the area of biodefense. Sales of its anthrax vaccines accounted for nearly half the Strategic National Stockpile’s half-billion-dollar annual budget through most of the last decade, The Times reported last month. That left the government with less money for items needed in a pandemic, and last year, the stockpile’s shortage of basic medical supplies became a symbol of the government’s bungled coronavirus response.

Though the original federal contract for the Baltimore plant required Emergent to demonstrate large-scale manufacturing of a pandemic influenza vaccine — envisioned by health officials as a pressure test of its abilities — Emergent had yet to do so, The Times reported on Tuesday. The company risked defaulting on the original deal, which had set a deadline of June 2020. The company also has separate agreements with the two vaccine makers worth more than $875 million.

In the effort to resolve the factory’s troubles, federal officials have simplified Emergent’s mission, limiting it to only producing Johnson & Johnson’s vaccine and forcing AstraZeneca to move its production lines elsewhere. Johnson & Johnson is also now asserting direct control over the manufacturing, although the work force at the plant in southeast Baltimore remains Emergent’s.

Related Articles

JPMorgan says China tech stocks are in a ‘good buying spot’ despite regulatory crackdown

JPMorgan Asset Management is bullish on Chinese technology stocks even though regulators are cracking down on internet giants in the mainland.Shares of major Chinese...

I.P.A. Signing Bonuses and Free Subs: Luring Labor as a Beach Economy Booms

REHOBOTH BEACH, Del. — Dogfish Head Craft Brewery is struggling to hire manufacturing workers for its beer factory and staff members for its restaurants...

Exclusive-Foxconn’s iPhone output in India down amid COVID surge-sources By Reuters

© Reuters. FILE PHOTO: The Apple Inc logo is shown outside the company's 2016 Worldwide Developers Conference in San Francisco, California, U.S. June 13,...

Stay Connected

21,914FansLike
2,507FollowersFollow
0SubscribersSubscribe
- Advertisement -

Latest Articles

JPMorgan says China tech stocks are in a ‘good buying spot’ despite regulatory crackdown

JPMorgan Asset Management is bullish on Chinese technology stocks even though regulators are cracking down on internet giants in the mainland.Shares of major Chinese...

I.P.A. Signing Bonuses and Free Subs: Luring Labor as a Beach Economy Booms

REHOBOTH BEACH, Del. — Dogfish Head Craft Brewery is struggling to hire manufacturing workers for its beer factory and staff members for its restaurants...

Exclusive-Foxconn’s iPhone output in India down amid COVID surge-sources By Reuters

© Reuters. FILE PHOTO: The Apple Inc logo is shown outside the company's 2016 Worldwide Developers Conference in San Francisco, California, U.S. June 13,...

Simon Guobadia: 5 Things To Know About ‘RHOA’ Star Porsha Williams’ Fiance

Who Is Simon Guobadia: 5 Things On Porsha Williams’ Fiance – Hollywood Life

Biden picks Rahm Emanuel as U.S. envoy to Japan -FT By Reuters

© Reuters. FILE PHOTO: Rahm Emanuel, former mayor of Chicago, listens during the Wall Street Journal CEO Council, in Washington, U.S., December 10, 2019....