An estimated 30 million to 50 million doses of Johnson & Johnson’s Covid-19 vaccine made early this year sits idle in Emergent BioSolutions Inc’s plant in Baltimore awaiting a green light from US regulators to ship, two sources familiar with the matter said.
Emergent, a contract drug manufacturer, is waiting for the US 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 US vaccine rollout by weeks.
