FDA preparing to clear roughly 10 million Johnson & Johnson Covid-19 vaccine doses

The Food and Drug Administration is preparing to clear two batches of Johnson & Johnson Covid-19 vaccines that were produced at the troubled Emergent BioSolutions facility in Baltimore, a source familiar with the plans told CNN.

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.

In March, Johnson & Johnson said the quality control process at the plant identified one batch of drug substance that did not meet quality standards. The statement followed a New York Times report that said as many as 15 million potential doses of vaccines had been ruined, delaying FDA authorization of the Baltimore plant. An FDA inspection report released in April detailed numerous concerns at the facility, including that Emergent had not thoroughly investigated cross-contamination of a viral vaccine drug substance batch, and there was not a thorough review of how people moved in and around the facility as a potential source of contamination.

No shipments of Johnson & Johnson’s coronavirus vaccine have gone out from the federal government in several weeks because the vaccine is in short supply, CNN has reported. The lack of shipments is directly linked to the issues related to the plant in Baltimore.

The lag in shipments comes as the pace of vaccination in the US has slowed in recent weeks.

In five states — Alabama, Louisiana, Mississippi, Tennessee and Wyoming — fewer than half of adult residents have received one dose of Covid-19 vaccine, according to data published Thursday by the US Centers for Disease Control and Prevention.

In the US overall, 64% of adults have received at least one dose of Covid-19 vaccine and about 53% are fully vaccinated. The President has set a goal of 70% of US adults getting at least one Covid vaccine shot by July 4, but the US may not reach that goal at this current pace.

Johnson & Johnson said this week that the FDA had authorized an extension of the shelf life of its Covid-19 vaccine. The move increases the refrigerated storage time for the vaccine from three months to four-and-a-half months, and comes as some states had said currently available doses were set to expire at the end of June, potentially before being used.

This story has been updated with additional information.