FDA OKs AstraZeneca’s Emergent-produced vaccine for export

After facing months of setbacks concerning its contract production of COVID-19 vaccine, Emergent BioSolutions (NYSE:EBS) is making progress.

Most recently, the FDA announced that “certain lots” of AstraZeneca (LON:AZN) COVID-19 vaccine drug substance produced in a facility in Baltimore are acceptable for export.

Last week, the FDA gave the company permission to restart Johnson & Johnson’s (J&J) COVID-19 vaccine production.

While Emergent BioSolutions signed an agreement with AstraZeneca to produce that company’s vaccine in July 2020, the Biden administration required Johnson & Johnson to manage the plant after identifying potential contamination. As a result, FDA ultimately required Johnson & Johnson to discard 60 million doses produced at the Emergent plant.

While the Johnson & Johnson vaccine has won emergency use authorization in the U.S., the AstraZeneca vaccine hasn’t.

The AstraZeneca vaccine, however, has found broad use internationally. FDA thus anticipates that the “AstraZeneca lots, or vaccine made from the lots, will now be exported for use,” as it explained in a statement.

To arrive at its conclusion, the agency carefully reviewed facility records and data from Emergent’s quality testing protocols.