WASHINGTON — A top federal pandemic official warned in
June that Emergent BioSolutions, the government contractor that last month threw
out millions of doses of COVID-19 vaccines because of contamination, lacked
enough trained staff and had a record of problems with quality control.
اضافة اعلان
A copy of the official’s assessment, obtained by The New
York Times, cited “key risks” in relying on Emergent to handle the production
of vaccines developed by both Johnson & Johnson and AstraZeneca at
Emergent’s Bayview plant in Baltimore.
The assessment, which has not been released publicly,
was based in part on a visit to the plant just days after the government
awarded Emergent a contract worth up to $628 million, mostly to prepare its
factories to make coronavirus vaccines as part of Operation Warp Speed.
Addressing the problems “will require significant
effort,” and the company “will have to be monitored closely,” said the report,
which was written by Carlo de Notaristefani, a manufacturing expert who has
overseen production of COVID-19 vaccines for the federal government since May.
Though marked as a draft, federal officials said the report was considered to
be final.
Ten months after his report, the plant has become a
major headache for the team named by President Joe Biden to oversee the
pandemic response. The Times reported on Tuesday on a host of quality control
problems, flagged in audits and investigations by AstraZeneca, Johnson &
Johnson, two federal agencies and Emergent’s own quality evaluators.
Federal officials ordered major changes to the plant
after revelations late last month that Emergent had to jettison between 13
million and 15 million doses of Johnson & Johnson’s vaccine. It is not
clear what will happen to another 62 million doses of the vaccine produced at
the plant, or whether Johnson & Johnson will be able to deliver the 24
million doses it has promised to the federal government by the end of the
month.
So far, the Food and Drug Administration has not
certified the factory to distribute any doses for public use, and the agency is
not expected to do so until it conducts a thorough review, which can take
weeks.
Asked about the June report, a company spokesman said
Wednesday night: “Emergent’s top priority continues to be the strengthening of
the supply chain for Johnson & Johnson’s vitally needed COVID-19 vaccine.”
.jpg)
.jpg)
