Johnson & Johnson’s plan to lean on partners to help produce its COVID-19 vaccine has hit a major bump. The international pharmaceutical giant disposed of 15 million doses of its one-shot vaccine after a batch produced by Emergent BioSystems failed quality control checks.
In a statement, Johnson & Johnson noted that Emergent’s Bayview factory in Baltimore, Maryland was not cleared to produce the vaccine by the FDA, and that none of the failed doses were finished or placed in vials for distribution. Johnson & Johnson also said it would put more of its own experts on the ground at Bayview to oversee technical operations and quality assurance.
“As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards,” the company said. “The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).”
In an interview with CBS, Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases confirmed that no COVID-19 drugs produced by the plant in question even came close to being administered.
“You have checks and balances,” said Fauci, and said it was “good news” that the contamination was detected. “Nothing from that plant has gone into anyone that we’ve administered to,” he said.
So far, all existing doses of the Johnson & Johnson vaccine were produced by the company’s own Janssen Pharmaceuticals factories in the Netherlands and shipped overseas. Johnson & Johnson has partnered with a number of other companies, including Emergent BioSystems, in an attempt to boost production.
Johnson & Johnson says that despite the setback, which will almost certainly delay Emergent BioSystems’ approval by the FDA to produce the vaccine, the company is still on target to deliver 24 million more doses through April, as previously promised.
Federal officials, including Fauci, attributed the failure to human error. The New York Times, which broke the story on the quality control failure, reported that workers at the plant mixed up two ingredients in an error that contaminated millions of doses.
The Associated Press reported that the company has a history of running afoul of the FDA’s quality guidelines. In December 2017, the FDA faulted the company for failing to correct “mold and yeast isolates” in a Massachusetts plant. In 2018, the FDA alleged that Emergent had “an unwritten policy of not conducting routine compliance audits.”
And, in 2020, as J&J was announcing its partnership with the company, the FDA complained to Emergent that its Bayview factory was falling short on a number of issues, including testing and lab procedure, data integrity concerns, and careless handling of rejected batches. Even before the facility was beginning to work on J&J’s COVID vaccine, the FDA told them that “separate or defined areas to prevent contamination or mix-ups are deficient.”
