The FDA had halted production of J&J's vaccine at the plant, run by
Emergent BioSolutions Inc, in April after an inspection flagged
numerous serious quality control and sanitary issues.
The regulator is now expected to give the plant an emergency use
authorization to produce COVID-19 vaccine as early as Friday, the
Journal said, citing U.S. officials.
As part of that arrangement to get the plant online, the United
States government and J&J have tentatively agreed that about 60
million doses of J&J vaccines made at the Baltimore plant now will
be cleared for use either in the United States or other countries,
according to the report.
The plant has produced millions of doses that were in inventory
awaiting authorization, but most aren't finished and are placed in
vials, the Journal said, adding it could take months before all
those doses are ready for use.
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J&J and Emergent declined to
comment, while the FDA did not immediately
respond to a request for comment.
Emergent had to toss out a batch of the J&J
vaccine in March after it became contaminated
with part of AstraZeneca Plc's COVID-19 vaccine,
which it was also making at the plant.
The U.S. government had then put J&J in charge
of the plant and stopped the British drugmaker
from using it.
(Reporting by Sahil Shaw in BengaluruEditing by
Chris Reese and Grant McCool)
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