The FDA had halted production of J & J’s vaccine at the plant, run by Emergent BioSolutions Inc, in April after an inspection reported numerous serious quality control and hygiene issues.
The regulator is now expected to give the plant emergency use authorization to produce the Covid-19 vaccine as early as Friday, the Journal said, citing US officials.
As part of the deal to bring the plant online, the US government and J&J have tentatively agreed that approximately 60 million doses of J&J vaccine manufactured at the Baltimore plant will now be licensed in the US or in other countries, according to the report.
The factory produced millions of doses that were in inventory awaiting clearance, but most are unfinished and are being placed in vials, the Journal said, adding that it could be months before all of those doses. are ready for use.
J&J and Emergent declined to comment, while the FDA did not immediately respond to a request for comment.
Emergent had to throw away a batch of J&J vaccine in March after being contaminated with part of AstraZeneca Plc’s Covid-19 vaccine, which it also made at the plant.
The US government then gave J&J responsibility for the plant and prevented the UK drugmaker from using it.