J&J Has Hands Full With ‘Troubled’ Vaccine Contractor
Johnson & Johnson is sending quality and compliance experts to its contract manufacturer Emergent Biosolutions after 15 million doses of its Covid-19 vaccine were determined to not meet “quality standards.” The doses were not expected to immediately be in the marketplace because the Baltimore (Bayview) manufacturing plant has been slow to get FDA approval. “Therefore, as we continue to work with FDA and Emergent toward the Emergency Use Authorization (EUA) of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson Covid-19 vaccine,” the company says.
The manufacturing snafu does not affect vaccine doses that are currently being delivered, but it will likely affect future shipments, especially now that FDA’s EUA clearance hangs in the balance. Johnson & Johnson plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021, with most of those delivered by the end of May.
Since 2017, Emergent has been repeatedly cited by FDA inspectors due to poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by the Associated Press (AP) through the Freedom of Information Act. A 4/2020 inspection related to a potential treatment for anthrax cited the Bayview plant for failing to ensure that electronic data generated through testing of drug ingredients “was protected from deletion or manipulation,” the AP report says. It also found 202 deletions and 543 reprocessed files, yet the company had not investigated how those alterations had occurred or their possible impact, according to the records. FDA’s lead investigator, Marcellinus Dordunoo, wrote that Emergent had not investigated these “data integrity concerns.”
Additionally, Emergent did not follow proper testing and lab procedures at Bayview, the FDA inspection records revealed, noting that “deviations from test methods are not investigated, and are manually corrected days after performance, with no supporting data or documented justification.” The agency also hit Emergent for “carelessness in the handling of rejected materials in the Bayview plant,” the AP reports. An inspector observed items in a “reject cage” that did not have reject labels, and wrote that “separate or defined areas to prevent contamination or mix-ups are deficient,” it says.
A 12/2017 inspection of an Emergent plant in Canton, MA said the company had not corrected “continued low level mold and yeast isolates” found in the facility. A 6/2018 inspection of a Baltimore (Camden) plant saw FDA inspectors questioning why Emergent had “an unwritten policy of not conducting routine compliance audits,” according to the AP. In another 2018 inspection, FDA noted Emergent’s ongoing problems managing contamination at the Baltimore facility where BioThrax is produced: “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not adequately established and followed.” FDA’s inspectors also noted that Emergent staff filling vials of vaccine held “their hands directly above open vials” in a way that violated sterility safeguards.