As many as 50 million doses of Johnson & Johnson’s COVID-19 vaccine are sitting idle at a plant in Baltimore, waiting for the U.S. Food and Drug Administration’s (FDA) approval to ship, Reuters reported.
Emergent BioSolutions reportedly needs the FDA to inspect and authorize the plant before shipments can begin.
The exact number of doses can’t be determined because Emergent only makes raw vaccine substances, Reuters noted.
In April, the FDA halted operations at Emergent’s facility due to the discovery of traces of material from AstraZeneca’s vaccine, which was also being manufactured at the facility at the time, the news service noted, adding that about 15 million doses of J&J’s vaccine were ruined, setting back its rollout by weeks.
The FDA said that the facility corrected the issues following a limited inspection after the April pause on manufacturing.
Materials manufactured for the vaccine at the plant before its shutdown could be enough to produce about 50 million doses, Reuters reported.
The U.S. contracted for 100 million J&J shots in early 2020 and ordered an additional 100 million in March.
J&J reportedly lowered its production target for 2021 to between 500 million and 600 million doses from around 1 billion after the shutdown in Baltimore. Starting next year, it is estimated to make 1 billion doses, Reuters noted.
The FDA last week voted unanimously to approve a booster shot for those who have already received the one-dose J&J vaccine.
— Updated at 8:15 a.m.