This is a significant development, given not a single usable dose of the Johnson & Johnson Covid-19 vaccine from that facility has been approved yet.
Around 10 million doses are expected to be included in these batches.
This decision comes after the FDA conducted a quality review on these batches, the source said. The agency is not expected to fully clear the facility yet, however. The FDA has been reviewing the batches on an individual basis so more are available to ship globally, given that demand in the US has dropped.
This is a breaking story and will be updated.