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Just two weeks after instructing Johnson & Johnson to take over operations at Emergent BioSolution’s noncompliant Baltimore manufacturing operation, FDA has called a halt in production of vaccine drug substance and to quarantine all remaining product at the Bayview plant. FDA initiated a “for cause” inspection of the facility last week to follow-up on violations found in an inspection last year, but requested the shut-down on April 16, 2021, according to an 8-K disclosure form filed by Emergent.1
This latest enforcement action further muddies the supply outlook for J&J’s troubled COVID-19 vaccine, which separately is being reviewed by FDA and the Centers for Disease Control and Prevention (CDC) as to the cause of rare blood clots following vaccination. The feds had stopped distribution and use of the J&J vaccine pending further review of the safety issues. Meanwhile, Emergent evidently has produced more than 60 million doses of the J&J vaccine, but cannot release the drug substance to a finish-and-fill operation until FDA certifies the Baltimore plant as meeting good manufacturing practices.
FDA had cited serious quality concerns at Emergent’s Bayview plant in an inspection in April 2020, as previously reported here (see PE April 9, 2021). That situation was disclosed when Emergent reported last month that it had to discard 15 million doses of the J&J vaccine drug substance due to possible cross-contamination of two vaccines. Journalists and investigators have further uncovered additional government reports and complaints about Emergent’s operations and practices, raising ongoing questions about how and why federal health officials continued to expand and extend contracts with the company.
The FDA form 483 inspection report issued a year ago described inadequate controls for computer and records systems, disregard of established test procedures and laboratory control mechanisms, failure to investigate deviations from test methods, unclear quality control unit responsibilities and procedures, and lack of employee training on cGMP practices. A final observation cited deficient operations to prevent contamination or mix-ups of products by having separate or defined areas for holding rejected components before disposition. FDA and other government agencies were aware of the serious quality control issues at the Emergent facility, even before the discovery that millions of doses of J&J vaccine doses had to be discarded due to a mix-up with vaccine ingredient being produced for AstraZeneca.
Even though J&J assumed responsibility for manufacturing its vaccine drug substance at the Emergent facility two weeks ago, that apparently was not sufficient time to address the systemic manufacturing issues identified by FDA. At that time, Emergent executives noted that it was receiving an additional $23 million from the Biomedical Advanced Research and Development Authority (BARDA) to improve its manufacturing operations to expand J&J vaccine production and downplayed its quality control issues.2 Hopefully those and other government funds will be used to resolve the vaccine quality issues in time to be useful.