Sources: Millions of J&J COVID-19 shots idling in facility

As many as 50 million doses of Johnson & Johnson's COVID-19 vaccine made earlier this year may be sitting idle in a Baltimore plant, awaiting a green light to ship from U.S. regulators.

That's according to two sources familiar with the situation, who asked not to be named because they were not authorized to speak publicly about it.

The Baltimore facility is run by Emergent BioSolutions, contracted by J&J to make vaccines.

But the plant was force to halt shipments in April after the U.S. Food and Drug Administration found the J&J vaccines were tainted with material from AstraZeneca's COVID-19 shots, 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.

The FDA said in a statement that it conducted a limited inspection of Emergent's facility in July. A previous inspection had turned up a raft of sanitary, safety and poor manufacturing issues at the plant.

The FDA must still authorize the plant before Emergent can ship the vaccines.

The exact number of J&J doses now sitting idle in Baltimore cannot be determined.

A source told Reuters Emergent only makes the raw vaccine substance, and does not make vials filled with finished product.

Following the Emergent plant shutdown, J&J lowered its production target for 2021 from around one billion doses to between 500 million and 600 million doses. It expects to be able to make one billion doses annually starting next year.

J&J has not specified whether it needs Emergent to restart production to hit its 2022 target.