Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.
The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.
New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized by the FDA for emergency use in March. A handful of days later, the Biden administration announced a contract for 100 million doses of the vaccine.
However, news came to light that workers at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.
A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” according to a statement from Johnson & Johnson. The batch did not reach the fill-and-finish stage of manufacturing.
In response to the error, J&J issued a news release over the weekend stating that it assumes full responsibility for the manufacturing of drug substance for the vaccine at the Emergent Bayview facility. It is adding dedicated leaders for operations and quality while significantly increasing the number of manufacturing, quality and technical operations personnel to work alongside specialists already at Emergent.
The company made a point to note that all doses of its COVID-19 vaccine distributed to date have met both company and regulatory quality standards. At the same time, it continues to work with the FDA toward the emergency use authorization (EUA) of the Emergent Bayview Facility.
Johnson & Johnson still expects to deliver the 100 million doses it is contracted to produce to the U.S. government by the end of May.