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 Emergent, a contract drug manufacturer, is waiting for the U.S. Food
and Drug Administration to approve release of those doses. The
agency must still inspect and authorize the plant before Emergent
can ship newly manufactured drug substance, one of the sources said.
The exact number of doses sitting idle cannot be determined, the
source said, because Emergent only makes raw vaccine substance and
does not fill vials with finished product.
The FDA in April halted operations at Emergent's production facility
after J&J's vaccine was found to be contaminated with material from
AstraZeneca's COVID-19 shots, which were also being manufactured
there at the time.
The contamination ruined about 15 million J&J doses and set back its
U.S. vaccine rollout by weeks.
Material manufactured for the J&J vaccine at the Baltimore plant
prior to the April shutdown and awaiting FDA approval could be
enough to produce as many as 50 million shots, the two sources said.
They asked not to be named because they were not authorized to speak
publicly on the issue.
Of the 100 million doses worth of vaccine material Emergent
described in an April Congressional hearing as being sidelined, the
FDA has so far cleared nine batches of J&J's vaccine and three
batches of AstraZeneca's. It has not disclosed how many doses were
in those batches.
Emergent in late July said it would resume production of J&J's
vaccine at the plant following additional FDA reviews, but has not
provided updates on production or timing of potential shipments.
[L1N2P535Q]
Emergent has begun making new vaccine substance, but the FDA has yet
to provide guidance on when it plans to inspect the Baltimore
facility, one of the sources said.
The FDA said in a statement that it conducted a limited inspection
of Emergent's facility in July to confirm it had conducted
corrective actions following the April production pause. A previous
inspection had turned up a raft of sanitary, safety and bad
manufacturing practice issues at the plant.
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The agency said it has not yet authorized the facility to ship doses
and continues to review batches made prior to the production halt.
It has based its batch approvals on reviews of facility records and
quality testing conducted by the manufacturer.
The FDA typically waits for a drug manufacturing facility to produce
multiple batches of its product before conducting an inspection,
according to a former FDA official who asked not to be named because
she was not authorized to speak with the media.
Following the Emergent plant shutdown, J&J lowered its production
target for 2021 to between 500 million and 600 million doses from
around 1 billion. It expects to be able to make 1 billion doses
annually starting next year.
J&J has not specified whether it needs Emergent to restart
production to hit its 2022 target. It has another manufacturing
facility in Leiden, Netherlands, and production agreements with
other contract manufacturers, including Catalent Inc and India's
Biological E.
The United States contracted with J&J for 100 million shots in 2020
and ordered an additional 100 million in March.
Last week, the FDA authorized J&J's vaccine as a booster for people
who are already vaccinated but desire additional protection against
COVID-19, including anyone over age 18 who originally received the
company's single-dose shot.
Use of J&J's vaccine fell sharply in the United States after it was
linked to a rare but potentially lethal blood clotting disorder.
(Reporting by Carl O'Donnell; Editing by Caroline Humer and Bill
Berkrot)
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