It looks like the final round of Emergent's AstraZeneca Covid-19 doses have been released
Four more batches of AstraZeneca’s Covid-19 vaccine that were made at Emergent BioSolutions’ Baltimore plant have been cleared for shipment outside the US by the FDA, but it seems like this will be the last round of updates the agency is providing in connection to the quarantined doses from the CDMO, wrapping up a nearly one-year saga that led to the tossing of millions of Covid-19 doses.
The FDA disclosed the news in its roundup on Friday, but did not make Emergent aware of the news, a spokesperson told Endpoints News in an email Tuesday. In the roundup, the agency said:
The AstraZeneca vaccine is not authorized for use in the U.S., but the FDA understands that these AstraZeneca lots, or vaccine made from these lots, may now be exported for use. The agency conducted a thorough review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review, taking into consideration the current worldwide COVID-19 public health emergency.
“At this time, the agency does not anticipate making any more determinations on additional AstraZeneca lots manufactured at the Emergent facility,” it said.
The problem originated at the company’s Bayview facility, which generally had been touted for its capacity to rapidly scale manufacturing. CEO Bob Kramer has repeatedly stated that his company was one of a few that stepped up to the plate when the company desperately needed manufacturing capacity. But as a result, drug substance from J&J’s batch was contaminated during a mix-up with AstraZeneca’s viral vectors. That led to 15 million doses of J&J’s shot being ruined, and 60 million doses total getting tossed, as the FDA quarantined and tested even more doses. Before Friday’s announcement, at least nine batches of J&J’s shot and three batches of AstraZeneca’s — good for about 100 million doses — had been released from that hold.
Meanwhile, an investigation of the Baltimore site revealed embarrassing details about the cleanliness of the site. A Form 483 revealed that the plant was filthy, with paint chipping on the walls, mold and other unknown black and brown substances growing and a failure to decontaminate bags of waste before transporting it throughout the warehouse.
Shares of the CDMO’s stock plummeted, dropping from $133.42 per share all the way down to $33.11 in November. Last month, founder and the original CEO Fuad El-Hibri announced he would retire in April.
In July, the FDA gave the go-ahead to resume production. last month, Emergent landed another big-money contract from BARDA to manufacture an anthrax vaccine for the national stockpile.