BALTIMORE — Top officials at the U.S. Food and Drug Administration detail a series of mistakes and costly human errors that rendered millions of doses of Johnson & Johnson’s COVID-19 vaccine unusable in a memo posted over the weekend.
The memo also elaborates on federal regulators’ decision to authorize use of two batches of the vaccine made around the same time as the tainted ones, saying while the facility did not operate in compliance, those products have been cleared following a testing and records-review period.
The new documents shed light on the process errors by Emergent BioSolutions, a Gaithersburg-based vaccine producer that runs a Baltimore plant subsidized with millions of dollars in federal money to make COVID-19 vaccines. The information also underscores the high stakes of the missteps, as both Johnson & Johnson and AsztraZeneca had contracted with Emergent to produce their immunizations at the plant also built and operated with federal subsidies.
Public health officials said the situation highlights the challenges of vaccine handling, and the tension that exists between matters involving both speed and efficiency but also precision and delicacy.
“It shows that making vaccines is complicated,” said Matthew Frieman, a professor of microbiology and immunology and coronavirus vaccine researcher at the University of Maryland School of Medicine in Baltimore.
Emergent BioSoultions’ Baltimore plant still lacks authorization to manufacture vaccines from the federal government, an FDA spokesperson said Monday, adding that the agency continues to work through issues there with Johnson & Johnson’s Janssen unit and Emergent BioSolutions management. Production at the plant near Johns Hopkins Bayview Hospital has been stalled since April.
Matt Hartwig, a spokesperson at Emergent BioSolutions, said the company will “continue working with the FDA and Johnson & Johnson to address any concerns, help get additional doses released and to resume production of this important COVID-19 vaccine.”
Janssen, the pharmaceutical company owned by Johnson & Johnson, detected AstraZeneca’s COVID-19 vaccine virus in a batch of J&J vaccine in March, according to the memo signed by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. AstraZeneca’s vaccine inserts the coronavirus’ DNA inside an adenovirus, a common vehicle used for vaccinations, which can train cells to fight the virus without replicating inside the body.
The discovery surfaced after Emergent workers had been instructed to adjust their practices after a series of visits by federal regulators to the site, where they found “crowded manufacturing areas with equipment and supplies; inadequate quality assurance support; and several issues related to laboratory controls. Additionally, improvements were needed in the material and equipment flows,” according to the latest FDA memo.
Inspectors in February also found “many personnel changes and new hires in Quality and Manufacturing ... as well as the need for better documentation and procedures, and consistency with established practices.”